Opioid Use DisorderPhase 1/2IBO-CARENCT07871877
Medically Supervised Ibogaine With 12-Month Digital Recovery Support for Opioid Use Disorder
A Phase 1/2 study testing Ibogaine Hydrochloride, Extended-release naltrexone injection, 380 mg and My-E-Health SENTINEL Digital Monitoring and Human-Gated Escalation Platform in people with Opioid Use Disorder and Opioid Withdrawal, run by Clive Michelsen at 1 site in United States.
Trial summary
IBO-CARE is a single-site Phase 1/2a study evaluating the safety, tolerability, feasibility and preliminary outcomes of medically supervised ibogaine with 12 months of recovery support in adults with moderate-to-severe opioid use disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid Use Disorder, Opioid Withdrawal, Substance Use Disorders
- What is being tested?
- Ibogaine Hydrochloride, Extended-release naltrexone injection, 380 mg and My-E-Health SENTINEL Digital Monitoring and Human-Gated Escalation Platform
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2027to 31 Dec 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult aged 18 to 65 years, inclusive.
- Meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision criteria for moderate or severe opioid use disorder, confirmed by a structured diagnostic assessment conducted by a qualified clinician.
- Has current physiological opioid dependence, current non-prescribed use, current opioid agonist treatment requiring an approved transition, or a documented recent history of moderate or severe opioid use disorder followed by supervised withdrawal. Participants entering A/C after at least 30 opioid-free days remain eligible if they otherwise meet the approved criteria. Cohort-specific entry rules govern assignment.
- Is voluntarily seeking treatment and has a documented clinical need for an additional treatment option, demonstrated by one or more of the following: Previous unsuccessful evidence-based treatment or medically supervised withdrawal; Relapse following treatment; Difficulty remaining engaged in treatment despite reasonable support; Previous overdose or clinically significant overdose risk; Intolerance of or insufficient response to a standard treatment; An informed and persistent preference to discontinue opioid agonist treatment after available alternatives have been explained.
- Has received a balanced explanation of available evidence-based treatments, including methadone, buprenorphine, extended-release naltrexone where clinically appropriate, psychosocial treatment, naloxone, and continuing addiction care.
- If receiving methadone, buprenorphine, or another long-acting opioid, has a written specialist-supervised transition and continuity plan that avoids abrupt or unsupervised discontinuation and preserves rapid re-entry to opioid agonist treatment where clinically indicated.
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- A Clinical Opiate Withdrawal Scale total score of at least 5 at the prespecified pre-treatment baseline is required only for the acute-withdrawal endpoint analysis, not for all study enrolment. Analysis eligibility is defined before treatment.
- Is medically and psychiatrically stable enough to participate, based on review by the principal investigator, addiction-medicine physician, cardiologist, and medical monitor.
- Demonstrates decision-making capacity and provides written informed consent.
- Has completed the required medical evaluation, including physical and neurological examination, medication and supplement review, laboratory testing, substance-use testing, and cardiac assessment.
- Has protocol-acceptable screening and immediate pre-dose 12-lead electrocardiogram findings, including a Fridericia-corrected QT interval no greater than 450 milliseconds for males and no greater than 470 milliseconds for females, unless stricter limits are required by the FDA-authorised protocol.
- Has clinically acceptable serum potassium, magnesium, calcium, renal function, hepatic function, haematology, and other protocol-required laboratory results. Correctable abnormalities must be corrected and rechecked before treatment.
- Is willing to remain at the clinical site throughout the required inpatient and observation period and participate in continuous telemetry, serial 12-lead electrocardiograms, laboratory testing, clinical examinations, and emergency procedures.
- Is willing to participate in psychological preparation, recovery planning, continuing addiction care, and 12 months of in-person and remote follow-up.
- Is willing to use SENTINEL, the study-provided Garmin Venu 4 and Apple phone. Equipment, connectivity, training and accessibility support are provided as needed. Lack of personal equipment alone does not exclude participation.
- Provides a reliable means of contact and, where permitted, identifies an emergency contact or supporting person.
- Participants of reproductive potential agree to protocol-required pregnancy testing and contraception requirements.
- Cohort Specific Entry Criteria
- Cohorts A and C: Complete the protocol-approved opioid-free interval and negative naloxone challenge before randomisation and treatment. The proposed stratification is 7-29 versus at least 30 opioid-free days. The precise counting method, opioid-specific safe interval, challenge procedure and naltrexone eligibility must be fixed under D6. No universal 30-day abstinence requirement applies. Naltrexone contraindications, product/excipient allergies and injection suitability must be checked before randomisation.
- Cohort B: Meet the approved recent-use entry pathway without a mandatory 30-day abstinence period. First-session stabilisation may require up to 48 hours in the planning model. Current methadone treatment does not permit direct entry. Previous methadone or buprenorphine treatment does not automatically exclude a person for life, but the approved specialist transition and objective readiness criteria must be satisfied before dosing. The recent-use interval, prohibited medicines and objective stabilisation criteria require D3/D6 confirmation.
- Clinical Priority: Evidence-based treatment, safe withdrawal management and emergency care take priority over research enrolment. A medically necessary therapy must not be stopped solely to qualify where discontinuation would create greater risk.
Who cannot join
- Congenital or acquired long-QT syndrome.
- Fridericia-corrected QT interval greater than 450 milliseconds for males or greater than 470 milliseconds for females on a protocol-qualifying screening or pre-dose electrocardiogram, or a stricter threshold required by the FDA-authorised protocol.
- History or current evidence of clinically important cardiac disease that could materially increase arrhythmia or haemodynamic risk, including: Torsade de pointes; Ventricular tachycardia or ventricular fibrillation; Previous sudden cardiac arrest; Clinically significant conduction disease; Brugada syndrome; Unexplained cardiac syncope; Cardiomyopathy; Significant heart failure; Significant valvular disease; Active myocarditis or pericarditis; Active or inadequately treated infective endocarditis; Unstable coronary disease; Recent myocardial infarction; Clinically significant atrial or ventricular arrhythmia.
- Family history suggesting an inherited arrhythmia syndrome or unexplained premature sudden cardiac death, unless specialist assessment establishes acceptable risk under the protocol.
- Clinically significant bradycardia, tachycardia, uncontrolled hypertension, symptomatic hypotension, or autonomic instability that has not been corrected before treatment.
- Uncorrected hypokalaemia, hypomagnesaemia, hypocalcaemia, or another clinically significant electrolyte or acid-base abnormality.
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- Clinically significant hepatic impairment, decompensated liver disease, acute hepatitis, impaired hepatic synthetic function, or laboratory abnormalities expected to alter ibogaine or noribogaine exposure materially.
- Clinically significant renal impairment or unstable renal disease.
- Unstable respiratory, neurological, endocrine, gastrointestinal, haematological, infectious, or other systemic disease that could increase the risk of treatment, aspiration, arrhythmia, vomiting, immobility, or emergency intervention.
- Current sepsis, uncontrolled systemic infection, active infective endocarditis, or another infection requiring urgent treatment.
- Current pregnancy, intended pregnancy during the protocol-defined risk period, or breastfeeding.
- Known hypersensitivity or previous serious adverse reaction to ibogaine, noribogaine, another iboga alkaloid, or an investigational-product excipient.
- Previous ibogaine exposure associated with clinically significant QT prolongation, arrhythmia, syncope, seizure, mania, psychosis, cardiac arrest, or another serious adverse event.
- Use of a medication, supplement, or substance that creates unacceptable risk through one or more of the following: QT prolongation or torsade de pointes; Bradycardia or conduction disturbance; Clinically significant cytochrome P450 2D6 inhibition or induction; Serotonergic toxicity; Reduction of the seizure threshold; Excessive sedation or respiratory depression; Hemodynamic instability.
- Inability to discontinue, substitute, or medically transition from a prohibited medication within a pharmacologically justified period. A medically necessary treatment will not be stopped solely to qualify for enrolment where discontinuation would create greater risk.
- Current methadone, buprenorphine, or another long-acting opioid unless the participant has completed the protocol-approved specialist-led transition procedure and has a written post-intervention treatment plan.
- Recent cocaine, methamphetamine, amphetamine, 3,4-methylenedioxymethamphetamine, or another stimulant exposure within the protocol-defined safety period, or a pre-dose toxicology finding considered to create unacceptable cardiovascular risk.
- Current alcohol, benzodiazepine, barbiturate, or other sedative-hypnotic dependence requiring separate withdrawal management, or current risk of alcohol- or sedative-withdrawal seizure or delirium.
- Severe uncontrolled polysubstance dependence requiring simultaneous medical detoxification or preventing interpretable safety assessment.
- Current intoxication, delirium, severe uncontrolled withdrawal, or another condition preventing valid informed consent or safe study procedures.
- History of epilepsy, an unprovoked seizure, a clinically significant seizure disorder, or a recent withdrawal-related seizure, unless specifically reviewed and accepted under the FDA-authorised protocol.
- Current psychotic disorder, active psychotic symptoms, schizophrenia-spectrum disorder, or current substance-induced psychosis.
- Current manic or hypomanic episode, uncontrolled bipolar I disorder, or previous ibogaine- or psychedelic-associated mania.
- Current suicidal intent, active suicide plan, recent high-lethality suicide attempt requiring acute intervention, or imminent risk of serious self-harm.
- Current homicidal intent, severe uncontrolled aggression, or behavioural instability that cannot be managed safely in the research setting.
- Severe cognitive impairment or another condition preventing informed consent or meaningful participation.
- An acute medical or psychiatric condition for which hospitalisation or another higher level of care takes priority over research participation.
- Receipt of another investigational drug within 30 days or five elimination half-lives, whichever is longer, unless specifically authorised by the sponsor and medical monitor.
- Inability or unwillingness to remain in the monitored treatment setting for the required period.
- Inability or unwillingness to participate in 12-month follow-up despite reasonable language, disability, equipment, connectivity, and technical accommodations.
- Any condition that, in the judgment of the principal investigator, cardiologist, addiction-medicine physician, psychiatrist, or independent medical monitor, would expose the participant to unreasonable risk, compromise informed consent, interfere materially with interpretation, or make participation contrary to the participant's interests.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1/2a Three-Cohort Study of Ibogaine Versus Extended-Release Naltrexone With 12-Month Recovery Support in Opioid Use Disorder: A Randomised Double-Dummy Comparison and a Recent-Use Cohort
IBO-CARE is a single-site Phase 1/2a study evaluating the safety, tolerability, feasibility and preliminary outcomes of medically supervised ibogaine with 12 months of recovery support in adults with moderate-to-severe opioid use disorder. Up to 120 candidates will be screened to enrol 60 adults aged 18-65 into three cohorts of 20. Participants meeting the shared opioid-free and negative naloxone-challenge criteria will be randomised 1:1 to Cohort A or Cohort C. Cohort A receives extended-release naltrexone 380 mg intramuscularly and matching oral placebo. Cohort C receives oral ibogaine hydrochloride and matching intramuscular placebo. Cohort B follows a separate, nonrandomised recent-use ibogaine pathway with matching intramuscular placebo and clinically supervised stabilisation. All cohorts attend three monitored oral-treatment admissions at Months 0, 1 and 2. Repeat ibogaine administrations require individual eligibility and safety release. The planned injection schedule comprises twelve calendar-monthly administrations at Months 0-11, with final follow-up at Month 12. All participants receive equivalent preparation, psychological support, continuing addiction care, monthly clinical review and SENTINEL digital recovery support with a Garmin Venu 4. The acute monitoring model includes continuous telemetry during a 72-hour post-dose window, serial 12-lead ECGs, laboratory monitoring, emergency capability and independent safety oversight. Monitoring is extended when clinically required. Wearable information does not replace clinical cardiac monitoring. SENTINEL combines participant reports, wearable trends and scheduled assessments, with high-risk findings reviewed by qualified clinicians. Cohorts A and C use a double-blind, double-dummy comparison. Cohort B is open to the treating team, with masked outcome assessment where feasible. Treatment guesses are collected because the acute effects of ibogaine may reveal allocation. The study estimates preliminary effects and is not designed to establish confirmatory efficacy. The IND application has not yet been filed. The study remains not yet recruiting. ClinicalTrials.gov registration and assignment of an NCT number do not authorise study conduct. Enrolment and investigational treatment will begin only after the IND is in effect, IRB approval is in place, and all applicable DEA, Colorado, investigational-product, clinical-site and digital-system requirements have been satisfied. The registration will be updated when the actual FDA filing details are available.
Read the detailed description
1 Purpose and design This funding- and authorisation-dependent study has three parallel cohorts. A and C constitute the randomised comparison of XR-naltrexone and ibogaine using matching oral and intramuscular placebos. B is a separate recent-use cohort and is analysed separately. The study evaluates acute safety, cardiac effects, eligible acute-withdrawal outcomes, feasibility and preliminary recovery outcomes during equivalent 12-month support. It does not include a placebo-only cohort deprived of continuing addiction care.
5 Study Description continued
2 Screening and baseline Potential participants undergo confirmation of DSM-5-TR moderate or severe opioid use disorder, consent capacity, treatment need and cohort eligibility. Screening includes medical and psychiatric history, physical and neurological examination, suicide and self-harm assessment, medicine and supplement reconciliation, recent-substance assessment, safety laboratory tests, pregnancy testing where applicable and specialist cardiovascular evaluation. Cardiac screening includes qualifying 12-lead ECGs, electrolytes and personal and family arrhythmia history, with further investigations where indicated.
The study provides a Garmin Venu 4, an Apple phone, training, connectivity and accessibility support. A 14-28-day digital baseline is sought where feasible without delaying clinically necessary care; shorter baselines and reasons are recorded. Baseline digital information includes participant-reported mood, craving, withdrawal, sleep, adherence and engagement, together with wearable-derived longitudinal wellness measures. Interpretation emphasises change within the participant. Minimum evaluable baseline coverage is specified in the data plan.
3 Cohort assignment and treatment transition Participants entering A/C complete the approved opioid-free interval and negative naloxone challenge before randomisation and assigned treatment. Randomisation is 1:1; the proposed opioid-free strata of 7-29 versus at least 30 days require confirmation. The safe interval depends on the opioid, treatment history and specialist assessment; the strata do not replace eligibility requirements.
Cohort B uses the approved recent-use pathway without a universal 30-day abstinence requirement. The planning model permits up to 48 hours of first-admission stabilisation. Current methadone treatment does not permit direct entry to B. Previous methadone or buprenorphine exposure is not a lifetime exclusion, but a protocol-approved specialist transition must be completed before dosing. Abrupt or unsupervised discontinuation of effective treatment is not required to enter the trial.
4 Monitored treatment admissions Three oral-treatment sessions occur at Months 0, 1 and 2. A receives matching oral placebo and B/C receive pharmaceutical-quality ibogaine hydrochloride. Formulation, dose, weight cap, timing, prohibited medicines, interaction controls, residual-noribogaine criteria and repeat-dose release conditions require final clinical and regulatory agreement. No numerical ibogaine dose is specified by this registration consolidation.
All cohorts receive equivalent clinical observation and supportive care. The shared planning model retains continuous telemetry for the 72-hour post-dose window, serial clinically interpreted 12-lead ECGs, vital signs, safety laboratory testing and pharmacokinetic sampling where applicable. Monitoring continues beyond the scheduled window when clinically required. Resuscitation capability, cardiology and emergency support, and a documented transfer pathway must be operational before site activation.
The protocol monitors cardiovascular, neurological and psychiatric adverse events, including dehydration, vomiting, aspiration, ataxia, falls, seizures, agitation, mania, psychosis and suicidality. Clinically relevant abnormalities require assessment and correction. QTcF of at least 500 ms or an increase of at least 60 ms enters the proposed stopping pathway; the confirmed measurement, action and cohort-pause rules must appear in the controlled clinical protocol. Consumer wearables are not used to measure QTc or to replace telemetry or 12-lead ECGs.
5 Study Description continued
5 Continuing care and injections The planned schedule comprises twelve calendar-monthly IM injections at Months 0-11: XR-naltrexone 380 mg in A and matching placebo in B/C. The first three injections occur during the corresponding monitored admissions when medically appropriate. The first-injection reference date, exact visit windows, eligibility, missed-dose management and rescue rules require D5 confirmation. No study injection is scheduled at Month 12.
All cohorts attend monthly clinical visits through Month 12 for review, ECG, protocol-defined laboratory testing, toxicology, recovery planning and face-to-face support. Naloxone challenge is performed only when required by the approved A/C pathway and clinical circumstances; it is not automatically repeated at every monthly visit. Weekly online integration continues through Month 3, with continuing clinical support throughout follow-up.
Before discharge, participants receive an individual continuing-care and overdose-prevention plan, naloxone access and education, information about reduced opioid tolerance, rapid access to opioid agonist treatment when indicated or requested, psychiatric and addiction referrals, emergency contacts and relevant social support. Rescue care and transition to ordinary treatment are not withheld to preserve study allocation. Follow-up continues after treatment discontinuation when consent permits.
6 Digital support and participant assessments Daily participant check-ins and Garmin-derived wellness data feed SENTINEL outside scheduled acute-admission pauses. Clinical monitoring continues during these pauses. PHQ-9 and GAD-7 are collected weekly through Month 12. EFP Mini, PCL-5 and the selected quality-of-life instrument are collected monthly, with registered change analyses at Months 1, 3, 6 and 12. SOWS and OOWS follow the acute schedule and are collected weekly through Month 3, then monthly during Months 4-12. Craving measurement and all instrument-specific rules require the decisions identified in Appendix C.
The five-state model comprises Green, Yellow, Orange, Red and Urgent. Orange requires same-day qualified clinical review; Red requires immediate live contact and urgent evaluation; Urgent directs immediate emergency action. Exact operational response windows, staffing, backup and coverage require the approved escalation SOP. Medical emergencies are directed to 911; 988 may support suicide or crisis needs without delaying emergency response. Students may support Green/Yellow activities under supervision and must not independently close Orange or higher events. SENTINEL does not autonomously diagnose, prescribe or change medication.
7 Trial data and regulatory status The validated study electronic data capture system remains the trial data system of record. Source records, ECGs, laboratory results, adverse events, protocol deviations and investigational-product accountability remain within the sponsor-approved architecture. SENTINEL supplies governed data transfers, audit trails, recorded human actions and longitudinal support. The study will report results by cohort, account for missingness and rescue treatment, and avoid treating the nonrandomised B cohort as part of the randomised A/C comparison.
The IND application has not yet been filed. The study remains not yet recruiting. ClinicalTrials.gov registration and assignment of an NCT number do not authorise study conduct. Enrolment and investigational treatment will begin only after the IND is in effect, IRB approval is in place, and all applicable DEA, Colorado, investigational-product, clinical-site and digital-system requirements have been satisfied. The registration will be updated when the actual FDA filing details are available.
- Being tested
- Ibogaine Hydrochloride, Extended-release naltrexone injection, 380 mg, Matching Oral Placebo, Matching Intramuscular Placebo, My-E-Health SENTINEL Digital Monitoring and Human-Gated Escalation Platform
- Keywords
- Ibogaine, Ibogaine Hydrochloride, Noribogaine, Opioid Use Disorder, Opioid Withdrawal, Opioid Dependence, Craving, Detoxification, Relapse, Overdose Prevention, Psychedelic-Assisted Treatment, Addiction Medicine, Digital Recovery Support, Remote Patient Monitoring, Wearable Technology, Garmin, Quality of Life, Continuing Care, Heart Rate Variability, QTc Prolongation
- Medical subject headings
- Opioid-Related Disorders, Substance-Related Disorders, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibogaine HydrochlorideDrug
Pharmaceutical-quality ibogaine hydrochloride administered orally during monitored admissions at Months 0, 1 and 2 in Cohorts B and C. The formulation, strength, weight-capped dose ceiling, interaction controls, pharmacokinetic schedule, repeat-dose release criteria, residual-noribogaine criteria and stopping rules require approval in the controlled protocol and Investigator's Brochure. Each administration requires a documented eligibility and safety review.
Arm Associations: B and C
Extended-release naltrexone injection, 380 mgDrug
Extended-release naltrexone 380 mg administered intramuscularly to Cohort A after the approved opioid-free interval, negative naloxone challenge and other clinical eligibility checks. The shared planning schedule is twelve calendar-monthly injections at Months 0-11. Exact timing, first-injection date, subsequent eligibility and missed-dose rules require D5 confirmation.
Arm Associations: A
Matching Oral PlaceboDrug
Matching oral placebo administered during the three monitored admissions at Months 0, 1 and 2 in Cohort A to maintain the double-dummy comparison. Composition, matching, manufacture, accountability and release follow the approved product documentation.
Arm Associations: A
Matching Intramuscular PlaceboDrug
Matching intramuscular placebo administered every four weeks for 12 months.
My-E-Health SENTINEL Digital Monitoring and Human-Gated Escalation PlatformDevice
SENTINEL is a study-provided digital monitoring and clinician-support platform used by all cohorts during baseline monitoring and 12-month follow-up. It combines daily participant reports, Garmin-derived longitudinal wellness data, scheduled psychometric assessments, adherence information, trend visualisation and protocol-defined risk-state classification. Orange, Red and Urgent states route to a named qualified clinician or emergency service under the escalation SOP. SENTINEL does not autonomously diagnose, prescribe, change medication or determine emergency treatment. It does not replace continuous telemetry, clinically interpreted 12-lead ECGs, toxicology, bedside examination or emergency assessment. Remote routines pause during scheduled acute admissions while clinical monitoring continues.
Arm Associations: A, B and C
Standardized Psychological Preparation, Integration and Recovery SupportBehavioural
All cohorts receive standardised psychological preparation, supportive care during monitored admissions, post-treatment integration, weekly online support through Month 3, relapse-prevention planning, overdose-prevention education, continuing-care coordination and monthly face-to-face clinical support through Month 12. Support intensity is equivalent across cohorts. Rescue care, access to evidence-based addiction treatment and individual clinical needs take priority over preserving study allocation.
Arm Associations: A, B and C
Garmin-Enabled Longitudinal Wellness MonitoringOther
All cohorts receive a Garmin Venu 4 with a study-provided Apple phone, training and connectivity. Protocol-specified wellness information includes sleep, resting heart rate, overnight heart-rate variability, respiration, overnight oxygen-saturation estimates, steps, activity, all-day stress and Body Battery. Data support exploratory longitudinal trends in SENTINEL. The wearable is not used to measure QTc, diagnose arrhythmia or replace telemetry, 12-lead ECGs or clinical assessment. Valid-day and baseline rules and scheduled acute-admission pauses are defined in the data plan.
Arm Associations: A, B and C
| Study group | Role | What they receive |
|---|---|---|
| Extended-Release Naltrexone With Oral Placebo and SENTINEL | Active comparator | Twenty participants meeting the protocol-approved opioid-free and negative naloxone-challenge criteria are randomised 1:1 against Cohort C. Participants attend monitored admissions at Months 0, 1 and 2 and receive matching oral placebo during each admission. XR-naltrexone 380 mg is administered intramuscularly on the planned calendar-monthly schedule at Months 0-11, for twelve injections. Participants receive equivalent preparation, clinical monitoring, psychological support, continuing care, monthly follow-up, SENTINEL support and Garmin monitoring through Month 12. Receives: Drug: Extended-release naltrexone injection, 380 mg; Drug: Matching Oral Placebo; Device: My-E-Health SENTINEL Digital Monitoring and Human-Gated Escalation Platform; Behavioral: Standardized Psychological Preparation, Integration and Recovery Support; Other: Garmin-Enabled Longitudinal Wellness Monitoring |
| Recent-Use Ibogaine With Placebo Injection and SENTINEL | Experimental | Twenty participants enter nonrandomly through the protocol-approved recent-opioid-use pathway. Three oral administrations of pharmaceutical-quality ibogaine hydrochloride are planned during monitored admissions at Months 0, 1 and 2, subject to eligibility and individual repeat-dose release. Matching IM placebo is administered on the planned calendar-monthly schedule at Months 0-11. The first admission includes clinically supervised stabilisation when required, with up to 48 hours allowed in the planning model. Equivalent preparation, clinical monitoring, psychological support, continuing care, monthly follow-up and SENTINEL/Garmin support continue through Month 12. Receives: Drug: Ibogaine Hydrochloride; Drug: Matching Intramuscular Placebo; Device: My-E-Health SENTINEL Digital Monitoring and Human-Gated Escalation Platform; Behavioral: Standardized Psychological Preparation, Integration and Recovery Support; Other: Garmin-Enabled Longitudinal Wellness Monitoring |
| Randomized Ibogaine With Placebo Injection and SENTINEL | Experimental | Twenty participants meeting the shared opioid-free and negative naloxone-challenge criteria are randomised 1:1 against Cohort A. Three oral administrations of pharmaceutical-quality ibogaine hydrochloride are planned during monitored admissions at Months 0, 1 and 2, subject to eligibility and individual repeat-dose release. Matching IM placebo is administered on the planned calendar-monthly schedule at Months 0-11. Equivalent preparation, clinical monitoring, psychological support, continuing care, monthly follow-up and SENTINEL/Garmin support continue through Month 12. Receives: Drug: Ibogaine Hydrochloride; Drug: Matching Intramuscular Placebo; Device: My-E-Health SENTINEL Digital Monitoring and Human-Gated Escalation Platform; Behavioral: Standardized Psychological Preparation, Integration and Recovery Support; Other: Garmin-Enabled Longitudinal Wellness Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants With One or More Treatment-Emergent Serious Adverse Events or Prespecified Adverse Events of Special Interest
Number of participants who experience at least one treatment-emergent serious adverse event or prespecified adverse event of special interest. Prespecified events include death, cardiac arrest, torsade de pointes, ventricular tachycardia or ventricular fibrillation, protocol-defined clinically significant QTcF prolongation, syncope, seizure, aspiration, intensive-care transfer, severe agitation, mania, psychosis, suicide attempt, precipitated withdrawal meeting serious-adverse-event criteria, or overdose. Each participant will be counted once regardless of the number of qualifying events.
Measured: From first assigned study intervention through 7 days after the third monitored admission, or 7 days after the last actual admission if the treatment course ends early.
Maximum Change From the Corresponding Pre-Dose Baseline in Fridericia-Corrected QT Interval
For each monitored admission, change in the Fridericia-corrected QT interval (QTcF) is calculated in milliseconds as each post-dose 12-lead ECG value minus the protocol-defined averaged pre-dose 12-lead ECG baseline for that admission. The outcome is the largest observed QTcF change for each participant across the three admissions. ECGs undergo clinical interpretation. This measure reports QTcF change only; threshold crossings and ventricular arrhythmias are separate outcomes.
Measured: Pre-dose through 72 hours after each assigned treatment administration at Months 0, 1 and 2.
Participants With QTcF of at Least 500 Milliseconds
Number of participants with at least one post-intervention, clinically interpreted 12-lead ECG showing a Fridericia-corrected QT interval (QTcF) of 500 milliseconds or more during any monitored admission. Each participant is counted once regardless of the number of qualifying ECGs. The reported unit is participants.
Measured: Pre-dose through 72 hours after each assigned treatment administration at Months 0, 1 and 2.
Participants With an Increase in QTcF of at Least 60 Milliseconds
Number of participants with at least one post-intervention increase in Fridericia-corrected QT interval (QTcF) of 60 milliseconds or more from the corresponding admission averaged pre-dose 12-lead ECG baseline. ECGs undergo clinical interpretation. Each participant is counted once regardless of the number of qualifying ECGs. The reported unit is participants.
Measured: Pre-dose through 72 hours after each assigned treatment administration at Months 0, 1 and 2.
Participants With a Protocol-Defined Ventricular Arrhythmia
Number of participants with torsade de pointes, sustained or clinically significant ventricular tachycardia, ventricular fibrillation, or another protocol-defined ventricular-arrhythmia stopping event during the acute monitoring windows. Events are determined from continuous telemetry, clinically interpreted 12-lead ECGs and clinical adjudication. Each participant is counted once. The reported unit is participants.
Measured: During the first 72 hours after each assigned treatment administration at Months 0, 1 and 2.
Area Under the Clinical Opiate Withdrawal Scale Total Score-Time Curve
Area under the total score-time curve from repeated Clinical Opiate Withdrawal Scale (COWS) assessments, reported in score-hours. COWS is an 11-item clinician-rated scale ranging from 0 to 48; higher scores indicate more severe withdrawal. The acute-withdrawal analysis population comprises participants with COWS of at least 5 at the prespecified pre-treatment baseline. Eligibility is assessed in each cohort, and results are reported separately by cohort. Cohort B is nonrandomised and is not pooled with Cohort C as a randomised comparison against Cohort A.
Measured: From pre-treatment baseline through 72 hours after the first assigned treatment administration in participants meeting the acute-withdrawal analysis criteria.
Secondary outcomes (29)
Area Under the Subjective Opiate Withdrawal Scale Total Score-Time Curve
Area under the total score-time curve from repeated Subjective Opiate Withdrawal Scale (SOWS) assessments, reported in score-hours. The 16 participant-reported items each score from 0 (not at all) to 4 (extremely), giving a total score from 0 to 64. Higher scores indicate more severe withdrawal. Use the same prespecified acute-withdrawal analysis population as for COWS, with results reported separately by cohort.
Measured: From pre-treatment baseline through 72 hours after the first assigned treatment administration in participants meeting the acute-withdrawal analysis criteria.
Change From Baseline in Objective Opiate Withdrawal Scale Total Score
The Objective Opiate Withdrawal Scale (OOWS) is a clinician-rated assessment of 13 observable signs of opioid withdrawal. Each sign is scored 0 if absent and 1 if present. The total score ranges from 0 to 13; higher scores indicate more severe withdrawal. Change is calculated as the total score at each follow-up assessment minus the pre-treatment baseline total score. Negative changes indicate improvement.
Measured: Pre-treatment baseline; 24, 48 and 72 hours and Day 7 after first assigned treatment; weekly through Month 3 and monthly during Months 4 to 12.
Participants Requiring Withdrawal Rescue Treatment
Number of participants requiring protocol-defined withdrawal rescue medication, opioid re-administration or transfer to another withdrawal-management pathway. Rescue use is ascertained from medication-administration and clinical records. Each participant is counted once regardless of the number of rescue interventions. The reported unit is participants; rescue type and reason are recorded separately.
Measured: From the first assigned treatment administration through 72 hours.
Number of Non-Prescribed Opioid-Use Days
Number of days with non-prescribed opioid use, assessed by Timeline Follow-Back and corroborated where possible by toxicology. A day is counted once regardless of the number of use episodes. Results are reported in days for each prespecified recall interval, separately by cohort. Prescribed opioid agonist treatment is distinguished from non-prescribed opioid use.
Measured: Pre-treatment baseline and monthly assessments through Month 12.
Percentage of Participants With Toxicology-Supported Non-Prescribed Opioid Abstinence
Percentage of participants with no reported non-prescribed opioid use during the prespecified recall interval and a concordant toxicology result at the assessment. Participant report and the study toxicology assessment are the measurement sources. The recall interval, specimen and test panel, handling of prescribed treatment, analysis denominator and missing-result rule require final specification.
Measured: Months 1, 3, 6 and 12 after first assigned study treatment.
Time to First Return to Non-Prescribed Opioid Use
Days from first assigned study treatment to the first protocol-defined return to non-prescribed opioid use among participants with established abstinence at the prespecified risk-set entry. Events are ascertained from participant reports and clinical or toxicology records. Ongoing use without established abstinence is not classified as a return to use.
Measured: From the first assigned study treatment through Month 12.
Percentage of Participants Engaged in Continuing Addiction Treatment
Percentage of enrolled participants with documented current engagement in at least one continuing-care pathway at each assessment, including methadone, buprenorphine, naltrexone, behavioural treatment, residential treatment, mutual-help or another protocol-accepted pathway. Engagement is determined from clinical/treatment records and participant report. The numerator is participants meeting the engagement definition; the denominator is all enrolled participants in the corresponding cohort. The range is 0-100%, with higher values indicating greater engagement.
Measured: Months 1, 3, 6 and 12 after first assigned study treatment.
Number of Overdose Events
Count of distinct fatal and nonfatal overdose events confirmed through clinical records, participant or collateral reports and independent clinical adjudication. Fatality and rescue interventions are recorded as event attributes. The reported unit is overdose events; repeat-event and episode-deduplication rules are prespecified.
Measured: From the first assigned study treatment through Month 12.
Number of Naloxone Rescue Administrations
Count of documented naloxone administrations for suspected or confirmed overdose, ascertained from clinical, emergency-service and participant or collateral records. Each separate administration is counted, including repeated administrations during one overdose. The reported unit is administrations. Protocol naloxone challenges are excluded.
Measured: From the first assigned study treatment through Month 12.
Number of Overdose-Related Emergency-Department Attendances
Count of emergency-department attendances for suspected or confirmed overdose, ascertained from clinical records and adjudication. The reported unit is attendances. Attendance episodes are deduplicated according to the prespecified event rules.
Measured: From the first assigned study treatment through Month 12.
Number of Overdose-Related Hospital Admissions
Count of inpatient admissions for suspected or confirmed overdose, ascertained from clinical records and adjudication. Transfers within the same inpatient episode are not counted as new admissions under the prespecified episode rules. The reported unit is admissions.
Measured: From the first assigned study treatment through Month 12.
Number of All-Cause Hospital Admissions
Count of inpatient hospital admissions for any cause, ascertained from clinical records and participant or collateral reports. Transfers within one inpatient episode are deduplicated. The reported unit is admissions. Planned research admissions are distinguished from clinical hospital admissions under the prespecified event rules.
Measured: From the first assigned study treatment through Month 12.
Number of Intensive-Care Admissions
Count of intensive-care admissions for any cause, ascertained from clinical records. Episode and transfer rules are prespecified to avoid duplicate counting. The reported unit is intensive-care admissions.
Measured: From the first assigned study treatment through Month 12.From the first assigned study treatment through Month 12.
Participants Who Die From Any Cause
Number of participants who die from any cause, established from clinical records, death records or other verified source documentation. Each participant is counted once. Cause and relationship to study treatment are recorded separately. The reported unit is participants.
Measured: From the first assigned study treatment through Month 12.
Participants With One or More Prespecified Suicide-Related Adverse Events
Number of participants with at least one qualifying suicide-related event, counted once regardless of the number of events. Event categories include qualifying suicidal ideation, suicide attempt, self-injury, crisis intervention, psychiatric hospitalisation or suicide death, as defined in the protocol. Events are ascertained using the selected suicide assessment, clinical records and clinical adjudication.
Measured: Baseline through Month 12.
Change From Baseline in Health-Related Quality of Life
Change from the pre-treatment baseline in the selected quality-of-life score. The instrument, version, specific score or domain, score range, direction and applicable value set must be selected before this outcome is released. Distinct index, visual-analogue or domain scores will be entered as separate measures if more than one is adopted.
Measured: Pre-treatment baseline and Months 1, 3, 6 and 12 after first assigned study treatment.
Change From Baseline in Patient Health Questionnaire-9 Total Score
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item participant-reported measure of depressive symptoms over the preceding 2 weeks. Each item is scored from 0 to 3, giving a total score from 0 to 27. Higher total scores indicate more severe depressive symptoms. Change is calculated as the score at each follow-up assessment minus the pre-treatment baseline score; negative changes indicate improvement.
Measured: Pre-treatment baseline and weekly through Month 12 after the first assigned treatment administration.
Change From Baseline in Generalized Anxiety Disorder-7 Total Score
The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item participant-reported measure of anxiety symptoms over the preceding 2 weeks. Each item is scored from 0 to 3, giving a total score from 0 to 21. Higher total scores indicate more severe anxiety symptoms. Change is calculated as the score at each follow-up assessment minus the pre-treatment baseline score; negative changes indicate improvement.
Measured: Pre-treatment baseline and weekly through Month 12 after the first assigned treatment administration.
Change From Baseline in PTSD Checklist for DSM-5 Total Score
The PTSD Checklist for DSM-5 (PCL-5) is a 20-item participant-reported measure of post-traumatic stress symptoms. Each item is scored from 0 to 4, giving a total score from 0 to 80. Higher scores indicate greater symptom severity. Change is the total score at each follow-up minus the pre-treatment baseline total; negative changes indicate improvement. Results are reported for participants meeting the prespecified trauma-analysis criteria.
Measured: Pre-treatment baseline and Months 1, 3, 6 and 12 after first assigned treatment.
Change From Baseline in EFP Mini Total Score
Change from the pre-treatment baseline in the EFP Mini overall score at each analysis visit. The study uses the 51-item EFP Mini assessment. The instrument owner must verify the official name, item coding, direction, reverse scoring, missing-item rules and validity of the overall total before the numerical range and interpretation are finalised. If only domain scores are adopted, each domain will be specified separately.
Measured: Pre-treatment baseline and Months 1, 3, 6 and 12 after first assigned study treatment.
Percentage of Participants Completing the Month 12 Clinical Outcome Assessment
Percentage of enrolled participants who complete the protocol-defined Month 12 clinical outcome assessment. The numerator is participants completing that assessment; the denominator is all enrolled participants in the corresponding cohort, multiplied by 100. The range is 0-100%, with higher percentages indicating greater follow-up retention. Reasons for non-completion, including withdrawal, loss to follow-up and death, are reported separately.
Measured: Month 12 after first assigned study treatment.
Percentage of Expected Daily Check-Ins Completed
For each participant, 100 multiplied by the number of completed scheduled SENTINEL daily check-ins divided by the number expected during follow-up. Completion is determined from platform audit records. Expected days exclude only the protocol-scheduled acute-admission pauses; unscheduled non-completion remains missing. The range is 0-100%, with higher values indicating greater adherence.
Measured: From activation of baseline monitoring through Month 12.
Percentage of Expected Wearable-Data Days Available
For each participant, 100 multiplied by the number of days with evaluable Garmin data divided by the number of expected monitoring days. Evaluable days meet the prespecified minimum wear and data-coverage criteria. Expected days exclude only protocol-scheduled acute-admission pauses; unscheduled missingness is retained. The range is 0-100%, with higher values indicating greater data availability.
Measured: From activation of baseline monitoring through Month 12.
Percentage of Scheduled Remote Assessments Completed
For each participant, 100 multiplied by the number of completed scheduled remote assessments divided by the number expected. Completion and expected assessments are determined from the protocol schedule and platform records, including approved acute-admission pause rules. Unscheduled missingness is retained. The range is 0-100%, with higher values indicating greater adherence.
Measured: From activation of baseline monitoring through Month 12.
Participants With Adverse Events During 12-Month Follow-Up
Number of participants with one or more serious or non-serious adverse events from first assigned treatment through Month 12, ascertained from clinical review, participant reports and source records. Each participant is counted once. Cardiovascular, neurological, psychiatric, overdose and substance-use event categories are recorded separately. This observation window includes and overlaps the acute primary safety window.
Measured: From the first assigned study treatment through Month 12.
Participants Enrolled by Cohort
Number of participants enrolled into each of Cohorts A, B and C, reported separately. Enrolment is established from signed consent and the study enrolment records under the protocol definition. Screening totals and reasons for non-enrolment are recorded separately. The reported unit is participants.
Measured: From the start of screening through closure of study enrolment.
Cohort B Participants Completing Protocol-Defined Stabilisation
Number of Cohort B entrants who satisfy the approved first-session stabilisation criteria before their first ibogaine administration. Status is determined by the clinical team from the stabilisation assessment and source records. The number entering stabilisation is reported as the denominator. The reported outcome unit is participants.
Measured: During the first admission, before the first ibogaine administration.
Participants Completing All Three Assigned Treatment Sessions
Number of participants who receive all three assigned oral treatment administrations at Months 0, 1 and 2: matching oral placebo in Cohort A or ibogaine in Cohorts B and C. Completion is determined from treatment-administration records and reported separately by cohort. Missed or stopped sessions and reasons are recorded. The reported unit is participants.
Measured: From the Month 0 session through completion of the Month 2 session.
Change From Baseline in Opioid Craving
Change from the pre-treatment baseline in the protocol-selected opioid-craving score. The instrument, version, item and total scoring, recall period, direction of interpretation and analysis rule require selection before registration. The selected score will be reported separately from withdrawal and other psychological assessments.
Measured: Pre-treatment baseline; weekly through Month 3 and monthly during Months 4 to 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start1 Jul 2027 (estimated)
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This single-site Phase 1/2a study comprises three parallel cohorts of 20 participants each. Participants meeting the shared opioid-free and negative naloxone-challenge criteria are randomised 1:1 to Cohort A, extended-release naltrexone with matching oral placebo, or Cohort C, ibogaine hydrochloride with matching intramuscular placebo. Cohort B enrols nonrandomly through a separate recent-use ibogaine pathway with matching intramuscular placebo. All cohorts have three planned monitored admissions at Months 0, 1 and 2 and 12 months of continuing care and follow-up. Repeat ibogaine administrations require individual release. The randomised comparison is A versus C; Cohort B is analysed separately.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clive Michelsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Clive Michelsen, My-E-Health UK LImited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871877
- Sponsor's protocol ID
- IBOCARE-2026-01
- Acronym
- IBO-CARE
- Status last verified
- Oct 2026
- First submitted
- 19 Sep 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The sponsor plans to make available a deidentified individual-participant dataset underlying the primary and secondary results, together with the data dictionary, study protocol, statistical analysis plan, informed-consent form, and relevant analytic code. Access will be considered for qualified researchers whose proposed use has received scientific and ethical review and who enter into a data-use agreement protecting participant privacy, Indigenous and community interests, commercial confidential information, and investigational-product information. Data are expected to become available approximately 12 months after publication of the principal results and remain available for at least five years. Access will be provided through a controlled-access repository or secure analysis environment. Direct identifiers, free-text clinical conversations, exact locations, device identifiers, and other information presenting an unacceptable re-identification risk will not be released. Wearable da
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a Three-Cohort Study of Ibogaine Versus Extended-Release Naltrexone With 12-Month Recovery Support in Opioid Use Disorder: A Randomised Double-Dummy Comparison and a Recent-Use Cohort
- ClinicalTrials.gov ID
- NCT07871877
- Acronym / sponsor ID
- IBO-CARE / IBOCARE-2026-01
- Keywords
- Ibogaine, Ibogaine Hydrochloride, Noribogaine, Opioid Use Disorder, Opioid Withdrawal, Opioid Dependence, Craving, Detoxification
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Clive MichelsenIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2027 (estimated)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 13 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
IBO-CARE is a single-site Phase 1/2a study evaluating the safety, tolerability, feasibility and preliminary outcomes of medically supervised ibogaine with 12 months of recovery support in adults with moderate-to-severe opioid use disorder. Up to 120 candidates will be screened to enrol 60 adults aged 18-65 into three cohorts of 20. Participants meeting the shared opioid-free and negative naloxone-challenge criteria will be randomised 1:1 to Cohort A or Cohort C. Cohort A receives extended-release naltrexone 380 mg intramuscularly and matching oral placebo. Cohort C receives oral ibogaine hydrochloride and matching intramuscular placebo. Cohort B follows a separate, nonrandomised recent-use ibogaine pathway with matching intramuscular placebo and clinically supervised stabilisation. All cohorts attend three monitored oral-treatment admissions at Months 0, 1 and 2. Repeat ibogaine administrations require individual eligibility and safety release. The planned injection schedule comprises twelve calendar-monthly administrations at Months 0-11, with final follow-up at Month 12. All participants receive equivalent preparation, psychological support, continuing addiction care, monthly clinical review and SENTINEL digital recovery support with a Garmin Venu 4. The acute monitoring model includes continuous telemetry during a 72-hour post-dose window, serial 12-lead ECGs, laboratory monitoring, emergency capability and independent safety oversight. Monitoring is extended when clinically required. Wearable information does not replace clinical cardiac monitoring. SENTINEL combines participant reports, wearable trends and scheduled assessments, with high-risk findings reviewed by qualified clinicians. Cohorts A and C use a double-blind, double-dummy comparison. Cohort B is open to the treating team, with masked outcome assessment where feasible. Treatment guesses are collected because the acute effects of ibogaine may reveal allocation. The study estimates preliminary effects and is not designed to establish confirmatory efficacy. The IND application has not yet been filed. The study remains not yet recruiting. ClinicalTrials.gov registration and assignment of an NCT number do not authorise study conduct. Enrolment and investigational treatment will begin only after the IND is in effect, IRB approval is in place, and all applicable DEA, Colorado, investigational-product, clinical-site and digital-system requirements have been satisfied. The registration will be updated when the actual FDA filing details are available.
Detailed description
1 Purpose and design This funding- and authorisation-dependent study has three parallel cohorts. A and C constitute the randomised comparison of XR-naltrexone and ibogaine using matching oral and intramuscular placebos. B is a separate recent-use cohort and is analysed separately. The study evaluates acute safety, cardiac effects, eligible acute-withdrawal outcomes, feasibility and preliminary recovery outcomes during equivalent 12-month support. It does not include a placebo-only cohort deprived of continuing addiction care.
5 Study Description continued
2 Screening and baseline Potential participants undergo confirmation of DSM-5-TR moderate or severe opioid use disorder, consent capacity, treatment need and cohort eligibility. Screening includes medical and psychiatric history, physical and neurological examination, suicide and self-harm assessment, medicine and supplement reconciliation, recent-substance assessment, safety laboratory tests, pregnancy testing where applicable and specialist cardiovascular evaluation. Cardiac screening includes qualifying 12-lead ECGs, electrolytes and personal and family arrhythmia history, with further investigations where indicated.
The study provides a Garmin Venu 4, an Apple phone, training, connectivity and accessibility support. A 14-28-day digital baseline is sought where feasible without delaying clinically necessary care; shorter baselines and reasons are recorded. Baseline digital information includes participant-reported mood, craving, withdrawal, sleep, adherence and engagement, together with wearable-derived longitudinal wellness measures. Interpretation emphasises change within the participant. Minimum evaluable baseline coverage is specified in the data plan.
3 Cohort assignment and treatment transition Participants entering A/C complete the approved opioid-free interval and negative naloxone challenge before randomisation and assigned treatment. Randomisation is 1:1; the proposed opioid-free strata of 7-29 versus at least 30 days require confirmation. The safe interval depends on the opioid, treatment history and specialist assessment; the strata do not replace eligibility requirements.
Cohort B uses the approved recent-use pathway without a universal 30-day abstinence requirement. The planning model permits up to 48 hours of first-admission stabilisation. Current methadone treatment does not permit direct entry to B. Previous methadone or buprenorphine exposure is not a lifetime exclusion, but a protocol-approved specialist transition must be completed before dosing. Abrupt or unsupervised discontinuation of effective treatment is not required to enter the trial.
4 Monitored treatment admissions Three oral-treatment sessions occur at Months 0, 1 and 2. A receives matching oral placebo and B/C receive pharmaceutical-quality ibogaine hydrochloride. Formulation, dose, weight cap, timing, prohibited medicines, interaction controls, residual-noribogaine criteria and repeat-dose release conditions require final clinical and regulatory agreement. No numerical ibogaine dose is specified by this registration consolidation.
All cohorts receive equivalent clinical observation and supportive care. The shared planning model retains continuous telemetry for the 72-hour post-dose window, serial clinically interpreted 12-lead ECGs, vital signs, safety laboratory testing and pharmacokinetic sampling where applicable. Monitoring continues beyond the scheduled window when clinically required. Resuscitation capability, cardiology and emergency support, and a documented transfer pathway must be operational before site activation.
The protocol monitors cardiovascular, neurological and psychiatric adverse events, including dehydration, vomiting, aspiration, ataxia, falls, seizures, agitation, mania, psychosis and suicidality. Clinically relevant abnormalities require assessment and correction. QTcF of at least 500 ms or an increase of at least 60 ms enters the proposed stopping pathway; the confirmed measurement, action and cohort-pause rules must appear in the controlled clinical protocol. Consumer wearables are not used to measure QTc or to replace telemetry or 12-lead ECGs.
5 Study Description continued
5 Continuing care and injections The planned schedule comprises twelve calendar-monthly IM injections at Months 0-11: XR-naltrexone 380 mg in A and matching placebo in B/C. The first three injections occur during the corresponding monitored admissions when medically appropriate. The first-injection reference date, exact visit windows, eligibility, missed-dose management and rescue rules require D5 confirmation. No study injection is scheduled at Month 12.
All cohorts attend monthly clinical visits through Month 12 for review, ECG, protocol-defined laboratory testing, toxicology, recovery planning and face-to-face support. Naloxone challenge is performed only when required by the approved A/C pathway and clinical circumstances; it is not automatically repeated at every monthly visit. Weekly online integration continues through Month 3, with continuing clinical support throughout follow-up.
Before discharge, participants receive an individual continuing-care and overdose-prevention plan, naloxone access and education, information about reduced opioid tolerance, rapid access to opioid agonist treatment when indicated or requested, psychiatric and addiction referrals, emergency contacts and relevant social support. Rescue care and transition to ordinary treatment are not withheld to preserve study allocation. Follow-up continues after treatment discontinuation when consent permits.
6 Digital support and participant assessments Daily participant check-ins and Garmin-derived wellness data feed SENTINEL outside scheduled acute-admission pauses. Clinical monitoring continues during these pauses. PHQ-9 and GAD-7 are collected weekly through Month 12. EFP Mini, PCL-5 and the selected quality-of-life instrument are collected monthly, with registered change analyses at Months 1, 3, 6 and 12. SOWS and OOWS follow the acute schedule and are collected weekly through Month 3, then monthly during Months 4-12. Craving measurement and all instrument-specific rules require the decisions identified in Appendix C.
The five-state model comprises Green, Yellow, Orange, Red and Urgent. Orange requires same-day qualified clinical review; Red requires immediate live contact and urgent evaluation; Urgent directs immediate emergency action. Exact operational response windows, staffing, backup and coverage require the approved escalation SOP. Medical emergencies are directed to 911; 988 may support suicide or crisis needs without delaying emergency response. Students may support Green/Yellow activities under supervision and must not independently close Orange or higher events. SENTINEL does not autonomously diagnose, prescribe or change medication.
7 Trial data and regulatory status The validated study electronic data capture system remains the trial data system of record. Source records, ECGs, laboratory results, adverse events, protocol deviations and investigational-product accountability remain within the sponsor-approved architecture. SENTINEL supplies governed data transfers, audit trails, recorded human actions and longitudinal support. The study will report results by cohort, account for missingness and rescue treatment, and avoid treating the nonrandomised B cohort as part of the randomised A/C comparison.
The IND application has not yet been filed. The study remains not yet recruiting. ClinicalTrials.gov registration and assignment of an NCT number do not authorise study conduct. Enrolment and investigational treatment will begin only after the IND is in effect, IRB approval is in place, and all applicable DEA, Colorado, investigational-product, clinical-site and digital-system requirements have been satisfied. The registration will be updated when the actual FDA filing details are available.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This single-site Phase 1/2a study comprises three parallel cohorts of 20 participants each. Participants meeting the shared opioid-free and negative naloxone-challenge criteria are randomised 1:1 to Cohort A, extended-release naltrexone with matching oral placebo, or Cohort C, ibogaine hydrochloride with matching intramuscular placebo. Cohort B enrols nonrandomly through a separate recent-use ibogaine pathway with matching intramuscular placebo. All cohorts have three planned monitored admissions at Months 0, 1 and 2 and 12 months of continuing care and follow-up. Repeat ibogaine administrations require individual release. The randomised comparison is A versus C; Cohort B is analysed separately.
| Arm | Type | Receives |
|---|---|---|
| Extended-Release Naltrexone With Oral Placebo and SENTINEL | Active comparator | Drug: Extended-release naltrexone injection, 380 mg, Drug: Matching Oral Placebo, Device: My-E-Health SENTINEL Digital Monitoring and Human-Gated Escalation Platform, Behavioral: Standardized Psychological Preparation, Integration and Recovery Support, Other: Garmin-Enabled Longitudinal Wellness MonitoringTwenty participants meeting the protocol-approved opioid-free and negative naloxone-challenge criteria are randomised 1:1 against Cohort C. Participants attend monitored admissions at Months 0, 1 and 2 and receive matching oral placebo during each admission. XR-naltrexone 380 mg is administered intramuscularly on the planned calendar-monthly schedule at Months 0-11, for twelve injections. Participants receive equivalent preparation, clinical monitoring, psychological support, continuing care, monthly follow-up, SENTINEL support and Garmin monitoring through Month 12. |
| Recent-Use Ibogaine With Placebo Injection and SENTINEL | Experimental | Drug: Ibogaine Hydrochloride, Drug: Matching Intramuscular Placebo, Device: My-E-Health SENTINEL Digital Monitoring and Human-Gated Escalation Platform, Behavioral: Standardized Psychological Preparation, Integration and Recovery Support, Other: Garmin-Enabled Longitudinal Wellness MonitoringTwenty participants enter nonrandomly through the protocol-approved recent-opioid-use pathway. Three oral administrations of pharmaceutical-quality ibogaine hydrochloride are planned during monitored admissions at Months 0, 1 and 2, subject to eligibility and individual repeat-dose release. Matching IM placebo is administered on the planned calendar-monthly schedule at Months 0-11. The first admission includes clinically supervised stabilisation when required, with up to 48 hours allowed in the planning model. Equivalent preparation, clinical monitoring, psychological support, continuing care, monthly follow-up and SENTINEL/Garmin support continue through Month 12. |
| Randomized Ibogaine With Placebo Injection and SENTINEL | Experimental | Drug: Ibogaine Hydrochloride, Drug: Matching Intramuscular Placebo, Device: My-E-Health SENTINEL Digital Monitoring and Human-Gated Escalation Platform, Behavioral: Standardized Psychological Preparation, Integration and Recovery Support, Other: Garmin-Enabled Longitudinal Wellness MonitoringTwenty participants meeting the shared opioid-free and negative naloxone-challenge criteria are randomised 1:1 against Cohort A. Three oral administrations of pharmaceutical-quality ibogaine hydrochloride are planned during monitored admissions at Months 0, 1 and 2, subject to eligibility and individual repeat-dose release. Matching IM placebo is administered on the planned calendar-monthly schedule at Months 0-11. Equivalent preparation, clinical monitoring, psychological support, continuing care, monthly follow-up and SENTINEL/Garmin support continue through Month 12. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Adult aged 18 to 65 years, inclusive.
- Meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision criteria for moderate or severe opioid use disorder, confirmed by a structured diagnostic assessment conducted by a qualified clinician.
- Has current physiological opioid dependence, current non-prescribed use, current opioid agonist treatment requiring an approved transition, or a documented recent history of moderate or severe opioid use disorder followed by supervised withdrawal. Participants entering A/C after at least 30 opioid-free days remain eligible if they otherwise meet the approved criteria. Cohort-specific entry rules govern assignment.
- Is voluntarily seeking treatment and has a documented clinical need for an additional treatment option, demonstrated by one or more of the following: Previous unsuccessful evidence-based treatment or medically supervised withdrawal; Relapse following treatment; Difficulty remaining engaged in treatment despite reasonable support; Previous overdose or clinically significant overdose risk; Intolerance of or insufficient response to a standard treatment; An informed and persistent preference to discontinue opioid agonist treatment after available alternatives have been explained.
- Has received a balanced explanation of available evidence-based treatments, including methadone, buprenorphine, extended-release naltrexone where clinically appropriate, psychosocial treatment, naloxone, and continuing addiction care.
Key exclusion criteria (31 listed)
- Congenital or acquired long-QT syndrome.
- Fridericia-corrected QT interval greater than 450 milliseconds for males or greater than 470 milliseconds for females on a protocol-qualifying screening or pre-dose electrocardiogram, or a stricter threshold required by the FDA-authorised protocol.
- History or current evidence of clinically important cardiac disease that could materially increase arrhythmia or haemodynamic risk, including: Torsade de pointes; Ventricular tachycardia or ventricular fibrillation; Previous sudden cardiac arrest; Clinically significant conduction disease; Brugada syndrome; Unexplained cardiac syncope; Cardiomyopathy; Significant heart failure; Significant valvular disease; Active myocarditis or pericarditis; Active or inadequately treated infective endocarditis; Unstable coronary disease; Recent myocardial infarction; Clinically significant atrial or ventricular arrhythmia.
- Family history suggesting an inherited arrhythmia syndrome or unexplained premature sudden cardiac death, unless specialist assessment establishes acceptable risk under the protocol.
- Clinically significant bradycardia, tachycardia, uncontrolled hypertension, symptomatic hypotension, or autonomic instability that has not been corrected before treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ibogaine HydrochloridePharmaceutical-quality ibogaine hydrochloride administered orally during monitored admissions at Months 0, 1 and 2 in Cohorts B and C. The formulation, strength, weight-capped dose ceiling, interaction controls, pharmacokinetic schedule, repeat-dose release criteria, residual-noribogaine criteria and stopping rules require approval in the controlled protocol and Investigator's Brochure. Each administration requires a documented eligibility and safety review. Arm Associations: B and C | Drug | Randomized Ibogaine With Placebo Injection and SENTINEL, Recent-Use Ibogaine With Placebo Injection and SENTINEL |
| Extended-release naltrexone injection, 380 mgExtended-release naltrexone 380 mg administered intramuscularly to Cohort A after the approved opioid-free interval, negative naloxone challenge and other clinical eligibility checks. The shared planning schedule is twelve calendar-monthly injections at Months 0-11. Exact timing, first-injection date, subsequent eligibility and missed-dose rules require D5 confirmation. Arm Associations: A | Drug | Extended-Release Naltrexone With Oral Placebo and SENTINEL |
| Matching Oral PlaceboMatching oral placebo administered during the three monitored admissions at Months 0, 1 and 2 in Cohort A to maintain the double-dummy comparison. Composition, matching, manufacture, accountability and release follow the approved product documentation. Arm Associations: A | Drug | Extended-Release Naltrexone With Oral Placebo and SENTINEL |
| Matching Intramuscular PlaceboMatching intramuscular placebo administered every four weeks for 12 months. | Drug | Randomized Ibogaine With Placebo Injection and SENTINEL, Recent-Use Ibogaine With Placebo Injection and SENTINEL |
| My-E-Health SENTINEL Digital Monitoring and Human-Gated Escalation PlatformSENTINEL is a study-provided digital monitoring and clinician-support platform used by all cohorts during baseline monitoring and 12-month follow-up. It combines daily participant reports, Garmin-derived longitudinal wellness data, scheduled psychometric assessments, adherence information, trend visualisation and protocol-defined risk-state classification. Orange, Red and Urgent states route to a named qualified clinician or emergency service under the escalation SOP. SENTINEL does not autonomously diagnose, prescribe, change medication or determine emergency treatment. It does not replace continuous telemetry, clinically interpreted 12-lead ECGs, toxicology, bedside examination or emergency assessment. Remote routines pause during scheduled acute admissions while clinical monitoring continues. Arm Associations: A, B and C | Device | Extended-Release Naltrexone With Oral Placebo and SENTINEL, Randomized Ibogaine With Placebo Injection and SENTINEL, Recent-Use Ibogaine With Placebo Injection and SENTINEL |
| Standardized Psychological Preparation, Integration and Recovery SupportAll cohorts receive standardised psychological preparation, supportive care during monitored admissions, post-treatment integration, weekly online support through Month 3, relapse-prevention planning, overdose-prevention education, continuing-care coordination and monthly face-to-face clinical support through Month 12. Support intensity is equivalent across cohorts. Rescue care, access to evidence-based addiction treatment and individual clinical needs take priority over preserving study allocation. Arm Associations: A, B and C | Behavioural | Extended-Release Naltrexone With Oral Placebo and SENTINEL, Randomized Ibogaine With Placebo Injection and SENTINEL, Recent-Use Ibogaine With Placebo Injection and SENTINEL |
| Garmin-Enabled Longitudinal Wellness MonitoringAll cohorts receive a Garmin Venu 4 with a study-provided Apple phone, training and connectivity. Protocol-specified wellness information includes sleep, resting heart rate, overnight heart-rate variability, respiration, overnight oxygen-saturation estimates, steps, activity, all-day stress and Body Battery. Data support exploratory longitudinal trends in SENTINEL. The wearable is not used to measure QTc, diagnose arrhythmia or replace telemetry, 12-lead ECGs or clinical assessment. Valid-day and baseline rules and scheduled acute-admission pauses are defined in the data plan. Arm Associations: A, B and C | Other | Extended-Release Naltrexone With Oral Placebo and SENTINEL, Randomized Ibogaine With Placebo Injection and SENTINEL, Recent-Use Ibogaine With Placebo Injection and SENTINEL |
Primary outcome
Participants With One or More Treatment-Emergent Serious Adverse Events or Prespecified Adverse Events of Special Interest
Time frame: From first assigned study intervention through 7 days after the third monitored admission, or 7 days after the last actual admission if the treatment course ends early.
Number of participants who experience at least one treatment-emergent serious adverse event or prespecified adverse event of special interest. Prespecified events include death, cardiac arrest, torsade de pointes, ventricular tachycardia or ventricular fibrillation, protocol-defined clinically significant QTcF prolongation, syncope, seizure, aspiration, intensive-care transfer, severe agitation, mania, psychosis, suicide attempt, precipitated withdrawal meeting serious-adverse-event criteria, or overdose. Each participant will be counted once regardless of the number of qualifying events.
Maximum Change From the Corresponding Pre-Dose Baseline in Fridericia-Corrected QT Interval
Time frame: Pre-dose through 72 hours after each assigned treatment administration at Months 0, 1 and 2.
For each monitored admission, change in the Fridericia-corrected QT interval (QTcF) is calculated in milliseconds as each post-dose 12-lead ECG value minus the protocol-defined averaged pre-dose 12-lead ECG baseline for that admission. The outcome is the largest observed QTcF change for each participant across the three admissions. ECGs undergo clinical interpretation. This measure reports QTcF change only; threshold crossings and ventricular arrhythmias are separate outcomes.
Participants With QTcF of at Least 500 Milliseconds
Time frame: Pre-dose through 72 hours after each assigned treatment administration at Months 0, 1 and 2.
Number of participants with at least one post-intervention, clinically interpreted 12-lead ECG showing a Fridericia-corrected QT interval (QTcF) of 500 milliseconds or more during any monitored admission. Each participant is counted once regardless of the number of qualifying ECGs. The reported unit is participants.
Participants With an Increase in QTcF of at Least 60 Milliseconds
Time frame: Pre-dose through 72 hours after each assigned treatment administration at Months 0, 1 and 2.
Number of participants with at least one post-intervention increase in Fridericia-corrected QT interval (QTcF) of 60 milliseconds or more from the corresponding admission averaged pre-dose 12-lead ECG baseline. ECGs undergo clinical interpretation. Each participant is counted once regardless of the number of qualifying ECGs. The reported unit is participants.
Participants With a Protocol-Defined Ventricular Arrhythmia
Time frame: During the first 72 hours after each assigned treatment administration at Months 0, 1 and 2.
Number of participants with torsade de pointes, sustained or clinically significant ventricular tachycardia, ventricular fibrillation, or another protocol-defined ventricular-arrhythmia stopping event during the acute monitoring windows. Events are determined from continuous telemetry, clinically interpreted 12-lead ECGs and clinical adjudication. Each participant is counted once. The reported unit is participants.
Area Under the Clinical Opiate Withdrawal Scale Total Score-Time Curve
Time frame: From pre-treatment baseline through 72 hours after the first assigned treatment administration in participants meeting the acute-withdrawal analysis criteria.
Area under the total score-time curve from repeated Clinical Opiate Withdrawal Scale (COWS) assessments, reported in score-hours. COWS is an 11-item clinician-rated scale ranging from 0 to 48; higher scores indicate more severe withdrawal. The acute-withdrawal analysis population comprises participants with COWS of at least 5 at the prespecified pre-treatment baseline. Eligibility is assessed in each cohort, and results are reported separately by cohort. Cohort B is nonrandomised and is not pooled with Cohort C as a randomised comparison against Cohort A.
29 secondary outcomes
Area Under the Subjective Opiate Withdrawal Scale Total Score-Time Curve
Time frame: From pre-treatment baseline through 72 hours after the first assigned treatment administration in participants meeting the acute-withdrawal analysis criteria.
Change From Baseline in Objective Opiate Withdrawal Scale Total Score
Time frame: Pre-treatment baseline; 24, 48 and 72 hours and Day 7 after first assigned treatment; weekly through Month 3 and monthly during Months 4 to 12.
Participants Requiring Withdrawal Rescue Treatment
Time frame: From the first assigned treatment administration through 72 hours.
Number of Non-Prescribed Opioid-Use Days
Time frame: Pre-treatment baseline and monthly assessments through Month 12.
Percentage of Participants With Toxicology-Supported Non-Prescribed Opioid Abstinence
Time frame: Months 1, 3, 6 and 12 after first assigned study treatment.
Time to First Return to Non-Prescribed Opioid Use
Time frame: From the first assigned study treatment through Month 12.
Percentage of Participants Engaged in Continuing Addiction Treatment
Time frame: Months 1, 3, 6 and 12 after first assigned study treatment.
Number of Overdose Events
Time frame: From the first assigned study treatment through Month 12.
Number of Naloxone Rescue Administrations
Time frame: From the first assigned study treatment through Month 12.
Number of Overdose-Related Emergency-Department Attendances
Time frame: From the first assigned study treatment through Month 12.
Number of Overdose-Related Hospital Admissions
Time frame: From the first assigned study treatment through Month 12.
Number of All-Cause Hospital Admissions
Time frame: From the first assigned study treatment through Month 12.
Number of Intensive-Care Admissions
Time frame: From the first assigned study treatment through Month 12.From the first assigned study treatment through Month 12.
Participants Who Die From Any Cause
Time frame: From the first assigned study treatment through Month 12.
Participants With One or More Prespecified Suicide-Related Adverse Events
Time frame: Baseline through Month 12.
Change From Baseline in Health-Related Quality of Life
Time frame: Pre-treatment baseline and Months 1, 3, 6 and 12 after first assigned study treatment.
Change From Baseline in Patient Health Questionnaire-9 Total Score
Time frame: Pre-treatment baseline and weekly through Month 12 after the first assigned treatment administration.
Change From Baseline in Generalized Anxiety Disorder-7 Total Score
Time frame: Pre-treatment baseline and weekly through Month 12 after the first assigned treatment administration.
Change From Baseline in PTSD Checklist for DSM-5 Total Score
Time frame: Pre-treatment baseline and Months 1, 3, 6 and 12 after first assigned treatment.
Change From Baseline in EFP Mini Total Score
Time frame: Pre-treatment baseline and Months 1, 3, 6 and 12 after first assigned study treatment.
Percentage of Participants Completing the Month 12 Clinical Outcome Assessment
Time frame: Month 12 after first assigned study treatment.
Percentage of Expected Daily Check-Ins Completed
Time frame: From activation of baseline monitoring through Month 12.
Percentage of Expected Wearable-Data Days Available
Time frame: From activation of baseline monitoring through Month 12.
Percentage of Scheduled Remote Assessments Completed
Time frame: From activation of baseline monitoring through Month 12.
Participants With Adverse Events During 12-Month Follow-Up
Time frame: From the first assigned study treatment through Month 12.
Participants Enrolled by Cohort
Time frame: From the start of screening through closure of study enrolment.
Cohort B Participants Completing Protocol-Defined Stabilisation
Time frame: During the first admission, before the first ibogaine administration.
Participants Completing All Three Assigned Treatment Sessions
Time frame: From the Month 0 session through completion of the Month 2 session.
Change From Baseline in Opioid Craving
Time frame: Pre-treatment baseline; weekly through Month 3 and monthly during Months 4 to 12.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- FDA Final Guidance-Psychedelic Drugs: Considerations for Clinical InvestigationsLink provided by the sponsor.
- Related Phase 1/2a Ibogaine Study-NCT0502940Link provided by the sponsor.
- Related Ibogaine Methadone-Detoxification Study-NCT04003948Link provided by the sponsor.
- Related Noribogaine Phase 1 Study-NCT06480981Link provided by the sponsor.
- Success Starts With YoLink provided by the sponsor.
- My-E-Health UK Limited, platform provider and administration.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. The sponsor plans to make available a deidentified individual-participant dataset underlying the primary and secondary results, together with the data dictionary, study protocol, statistical analysis plan, informed-consent form, and relevant analytic code. Access will be considered for qualified researchers whose proposed use has received scientific and ethical review and who enter into a data-use agreement protecting participant privacy, Indigenous and community interests, commercial confidential information, and investigational-product information. Data are expected to become available approximately 12 months after publication of the principal results and remain available for at least five years. Access will be provided through a controlled-access repository or secure analysis environment. Direct identifiers, free-text clinical conversations, exact locations, device identifiers, and other information presenting an unacceptable re-identification risk will not be released. Wearable da
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ibogaine Hydrochloride, Extended-release naltrexone injection, 380 mg and My-E-Health SENTINEL Digital Monitoring and Human-Gated Escalation Platform in people with Opioid Use Disorder and Opioid Withdrawal, run by Clive Michelsen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clive S Michelsen, M.Sc. (+46704065696, clive.michelsen@my-e-health.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants With One or More Treatment-Emergent Serious Adverse Events or Prespecified Adverse Events of Special Interest (time frame: From first assigned study intervention through 7 days after the third monitored admission, or 7 days after the last actual admission if the treatment course ends early.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.