Opioid Use Disorder (OUD)Phase 3ACROSNCT06940674
Adjunctive Cannabidiol for Recovery From Opioid Study
A Phase 3 study testing Cannabidiol in people with Opioid Use Disorder (OUD), run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
Trial summary
The long-term goal of the project is to determine whether cannabidiol (CBD) can reduce craving and relapse in individuals with opioid use disorder (OUD). The first phase of this project was an open cross-over design study in healthy individuals to confirm the safety and pharmacokinetic (PK) effects of CBD (BSPG CBD… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid Use Disorder (OUD)
- What is being tested?
- Cannabidiol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Jun 2025to 15 Aug 2027
- Phase
- Phase 3
- 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
- Individuals between 18 and 65 years old.
- Ability to understand and give informed consent.
- Current opioid use disorder (OUD) or OUD in remission while on maintenance therapy with OAT, as determined by DSM-5 with the M.I.N.I. interview (Mini-International Neuropsychiatric Interview).
- Current opioid agonist maintenance treatment with methadone or buprenorphine for at least 14 days prior to consent. With the following more specific criteria for each of these two medications:
- Current methadone maintenance treatment with a dose of ≥ 10mg/day, (maximum: 250mg/day), AND urinary toxicology positive for methadone and 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP).
- Current buprenorphine maintenance treatment with a dose of ≥ 2mg/day (maximum: 32mg/day), AND urinary toxicology positive for buprenorphine.
Who cannot join
- Participants who are non-English speaking.
- Psychiatric conditions under DSM-5 (examined with the MINI) that would make study participation unsafe, or which would prevent adherence to study procedure; examples include: suicidal (i.e. high risk for suicide on the Columbia suicide severity rating scale (C-SSRS) screen version) or homicidal ideation requiring immediate attention, inadequately-treated mental health disorder (e.g., active psychosis, uncontrolled bipolar disorder).
- Current diagnosis of a severe substance use disorder (except for opioid and nicotine/tobacco) in the past 3 months, based on the MINI interview, that would preclude safe participation in the study as determined by the study medical clinician.
- Signs of acute drug intoxication when arriving at the study site as determined by clinician assessment.
- Medical or psychiatric contraindications for CBD administration (e.g., history of hypersensitivity to cannabinoids); or any of the ingredients in the product (gelatin or sesame oil).
- Showing signs of acute opioid withdrawal symptoms (as determined by the result of the Clinical Opiate Withdrawal Scale (COWS). A Score of ≥ 5 or as interpreted by the investigator will be considered a positive result for withdrawal symptoms).
Show all 12Show fewer
- Have a medical condition that would make study participation unsafe, which would make treatment compliance difficult, or would prevent adherence to study procedure. This includes but is not limited to the following criteria: • < 30mL/min/1.73m2 eGFR. •QTc Fridericia > 500ms at screening. •Elevated liver enzymes at screening. The exclusionary lab values are: >4x the upper limit of normal (ULN) per laboratory criteria for AST or ALT or >1.5x ULN for bilirubin.
- Participating in another pharmacotherapeutic trial in the past 3 months.
- Participants who have used (within 14 days prior to consent) or plan to use (during the 24-week treatment period) any medications, dietary supplements (and/or grapefruit juice), or combination of medications and supplements known to alter the metabolism of, or interact with CBD (buproprion, rifampin, barbiturates, phenothiazines, cimetidine, anticoagulants, antiplatelets, etc.).
- For women: being pregnant (positive urine test for pregnancy) or breastfeeding.
- Not using an appropriate method of contraception such as hormonal contraception (oral hormonal contraceptives, Depo-Provera, Nuva-Ring), intrauterine device (IUD), sterilization, or double barrier method (combination of any two barrier methods used simultaneously, i.e. condom, spermicide, diaphragm).
- Participants who have been court mandated to attend treatment centers
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Ashanta Carter, (212) 585-4653, ashanta.carter@mssm.edu
Yasmin Hurd
- Recruiting
CODA Treatment Recovery
Portland, Oregon, 97214
Hannah Lemons, HannahLemons@codainc.org
Tara Chowdhury
About this study
Official title: Adjunctive Cannabidiol for Recovery From Opioid Study (ACROS)
The long-term goal of the project is to determine whether cannabidiol (CBD) can reduce craving and relapse in individuals with opioid use disorder (OUD). The first phase of this project was an open cross-over design study in healthy individuals to confirm the safety and pharmacokinetic (PK) effects of CBD (BSPG CBD; Brains Bioceutical). The second phase was a double-blinded randomized controlled trial to determine whether CBD reduces craving and anxiety in individuals with OUD maintained on opioid agonist therapy. This phase 3 trial will determine whether CBD can serve as a potential adjunct treatment to reduce illicit opioid use in individuals with OUD maintained on opioid agonist therapy.
Read the detailed description
Responding to the urgent calls for developing non-opioid therapeutics to address the opioid addiction epidemic, we have been investigating the therapeutic potential of cannabidiol (CBD), a non-intoxicating cannabinoid as a possible strategy. Our preclinical animal studies demonstrated that CBD decreases cue-induced heroin seeking behavior during drug abstinence, associated with the incubation of craving. Moreover, the effects of CBD to reduce heroin-seeking behavior was still evident even in animals that were maintained on methadone. We also showed in randomized, double-blind placebo- controlled design human clinical trials that acute CBD (Epidiolex) administration (400 mg and 800mg) decreased craving and anxiety associated with heroin cues in abstinent individuals with heroin use disorder, an effect that persisted even a week after the last CBD dose (given daily for 3 days). Moreover, another of our human studies showed that CBD was safe even in combination with a potent opioid agonist (fentanyl) to address a potential relapse condition suggesting negligible negative interaction with opioids. Building on those studies, we next set out to investigate the potential for CBD as an adjunctive treatment to methadone or buprenorphine in opioid use disorder (OUD). To that end, we first conducted Phase 1 pharmacokinetic studies with a CBD formulation in oral capsules (BSPG CBD; Brains Bioceutical) in healthy participants that showed that oral administration of BSPG CBD (400 mg) led to comparable pharmacokinetic parameters of the CBD plasma levels and its active metabolite as Epidiolex (400 mg), an FDA-approved comparator CBD product that previously reduced craving. In the Phase 2 clinical trial, we evaluated the effect of 200mg CBD (vs placebo) twice daily for 4 weeks and an additional 4 weeks of 400 mg CBD, twice daily, on cue-induced craving and anxiety in individuals with OUD who are maintained on methadone or buprenorphine. In the next phase of this IND application, we will extend the Phase 2 study to evaluate the effects of 200mg CBD, 400 mg CBD and placebo, taken twice daily, over a 24-week period in the OUD individuals maintained on methadone or buprenorphine. Our goals in this double-blinded randomized controlled clinical trial (RCT) are to investigate the potential of CBD to 1) decrease illicit opioid use and 2) reduce craving.
- Conditions
- Opioid Use Disorder (OUD)
- Being tested
- Cannabidiol, Placebo
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabidiolDrug
Also called CBD
1 capsule CBD 200mg
PlaceboDrug
Bovine Gel Placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| 1 capsule CBD (200 mg) | Experimental | 1 capsule 200 mg CBD 2x per day Receives: Drug: Cannabidiol |
| 2 capsules CBD (400 mg) | Experimental | 2 capsules 400 mg CBD 2x per day Receives: Drug: Cannabidiol |
| 1 capsule placebo and 2 capsules placebo | Placebo comparator | 1 capsule 200 mg placebo 2x per day or 2 capsules 400 mg placebo 2x per day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of study participants with negative urine toxicology for illicit opioid use
Percentage of study participants with negative urine toxicology for illicit opioid use over the course of 24 weeks.
Measured: 24 weeks
Secondary outcomes (15)
Concentration of illicit opioids
Concentration of illicit opioids in quantitative plasma toxicology (plasma every four weeks)
Measured: Duration of the trial, 24 weeks
Weeks of abstinence
Weeks of abstinence of illicit opioid use
Measured: Duration of the trial, 24 weeks
Use of non-opioid illicit substances
Number of weeks using other non-opioid illicit substances
Measured: Duration of the trial, 24 weeks
Duration of first opioid abstinence
Duration of first opioid abstinence, defined as the number of weeks from randomization to first opioid test positive or urine test missed.
Measured: Duration of the trial, 24 weeks
Cue-induced Visual Analog Scale for craving (VASC)
Cue-induced Visual Analog Scale for craving (VASC)
Cue-induced Visual Analog Scale for craving is used to measure subjective craving responses to a drug and neutral video cues evaluated in the clinic. Total scale ranges from 0-10, with higher scores indicating extreme cravings.
Measured: At 12 and 24-week time points
Cue-induced Visual Analog Scale for anxiety (VASA)
Cue-induced Visual Analog Scale for anxiety (VASA)
Cue-induced Visual Analog Scale Anxiety is used to measure subjective anxiety responses to a drug and neutral video cue evaluated in the clinic. Total scale from 0-10, with higher score indicating extreme anxiety.
Measured: At 12 and 24-week time points
Change in illicit opioids in plasma toxicology
Change in illicit opioids in plasma toxicology
Measured: 24 weeks
Change in illicit opioids in urine toxicology
Change in illicit opioids in urine toxicology
Measured: 24 weeks
Study Retention
Number of participants remaining in the study
Measured: 24 weeks
Opioid Craving Questionnaire (OCQ)
General craving self-report using Opioid Craving Questionnaire (OCQ)
Total scale from 0-9, with higher score indicating more severe craving
Measured: Every 4 weeks up to 24 weeks
Generalized Anxiety Disorder Scale (GAD7)
General anxiety self-report using the Generalized Anxiety Disorder Scale (GAD7).
The General Anxiety Disorder 7-item questionnaire (GAD-7) is a 7-item questionnaire that asks user to rank how often they have been bothered by seven problems over the past two weeks from "0" (not at all) to "3" (nearly every day). The items that users are asked to rank levels of nervousness, anxiousness, relaxing, restlessness, irritability and fearfulness. Full scale from 0-21, with higher score indicating more symptoms.
Measured: Every 4 weeks up to 24 weeks
Substance use other than opioids
Proportion of substance use other than opioids
Measured: Duration of the trial, 24 weeks
Methadone plasma concentrations
Methadone plasma concentrations
Measured: Duration of the trial, 24 weeks
Buprenorphine and metabolite plasma concentrations
Buprenorphine and metabolite plasma concentrations
Measured: Duration of the trial, 24 weeks
Retention in opioid agonist therapy
Proportion of participants who remained in treatment with opioid agonist therapy
Measured: Duration of the trial, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start13 Jun 2025
- Primary completion15 Jul 2027 (estimated)
- Study completion15 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use Disorder (OUD)Studies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization will be carried out within each site using stratification factors. Using stratified block randomization with randomly varying block sizes, participants who meet the eligibility requirements and provide informed consent will be randomly allocated to one of the study arms (1 capsule CBD (200 mg), 2 capsules CBD (400 mg), 1 capsule placebo and 2 capsules placebo) with a 1:1:0.5:0.5 allocation ratio. The placebo groups will be combined for statistical analysis purposes. Random permuted blocks sizes within stratification groups will be used to minimize the chance of selection bias.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), International Center for Health Outcomes and Innovation Research, Brains Bioceutical
- Responsible party
- Principal investigator, Yasmin Hurd, Icahn School of Medicine at Mount Sinai
- Investigators
- Yasmin Hurd, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06940674
- Sponsor's protocol ID
- STUDY-24-01494
- Other IDs
- UH3DA050323
- Acronym
- ACROS
- Status last verified
- Sep 2026
- First submitted
- 15 Apr 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Cannabidiol for Recovery From Opioid Study (ACROS)
- ClinicalTrials.gov ID
- NCT06940674
- Acronym / sponsor ID
- ACROS / STUDY-24-01494
- Conditions
- Opioid Use Disorder (OUD)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), International Center for Health Outcomes and Innovation Research, Brains Bioceutical
- Study start
- 13 Jun 2025 (actual)
- Primary completion
- 15 Jul 2027 (estimated)
- Study completion
- 15 Aug 2027 (estimated)
- First posted
- 23 Apr 2025 (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.
The long-term goal of the project is to determine whether cannabidiol (CBD) can reduce craving and relapse in individuals with opioid use disorder (OUD). The first phase of this project was an open cross-over design study in healthy individuals to confirm the safety and pharmacokinetic (PK) effects of CBD (BSPG CBD; Brains Bioceutical). The second phase was a double-blinded randomized controlled trial to determine whether CBD reduces craving and anxiety in individuals with OUD maintained on opioid agonist therapy. This phase 3 trial will determine whether CBD can serve as a potential adjunct treatment to reduce illicit opioid use in individuals with OUD maintained on opioid agonist therapy.
Detailed description
Responding to the urgent calls for developing non-opioid therapeutics to address the opioid addiction epidemic, we have been investigating the therapeutic potential of cannabidiol (CBD), a non-intoxicating cannabinoid as a possible strategy. Our preclinical animal studies demonstrated that CBD decreases cue-induced heroin seeking behavior during drug abstinence, associated with the incubation of craving. Moreover, the effects of CBD to reduce heroin-seeking behavior was still evident even in animals that were maintained on methadone. We also showed in randomized, double-blind placebo- controlled design human clinical trials that acute CBD (Epidiolex) administration (400 mg and 800mg) decreased craving and anxiety associated with heroin cues in abstinent individuals with heroin use disorder, an effect that persisted even a week after the last CBD dose (given daily for 3 days). Moreover, another of our human studies showed that CBD was safe even in combination with a potent opioid agonist (fentanyl) to address a potential relapse condition suggesting negligible negative interaction with opioids. Building on those studies, we next set out to investigate the potential for CBD as an adjunctive treatment to methadone or buprenorphine in opioid use disorder (OUD). To that end, we first conducted Phase 1 pharmacokinetic studies with a CBD formulation in oral capsules (BSPG CBD; Brains Bioceutical) in healthy participants that showed that oral administration of BSPG CBD (400 mg) led to comparable pharmacokinetic parameters of the CBD plasma levels and its active metabolite as Epidiolex (400 mg), an FDA-approved comparator CBD product that previously reduced craving. In the Phase 2 clinical trial, we evaluated the effect of 200mg CBD (vs placebo) twice daily for 4 weeks and an additional 4 weeks of 400 mg CBD, twice daily, on cue-induced craving and anxiety in individuals with OUD who are maintained on methadone or buprenorphine. In the next phase of this IND application, we will extend the Phase 2 study to evaluate the effects of 200mg CBD, 400 mg CBD and placebo, taken twice daily, over a 24-week period in the OUD individuals maintained on methadone or buprenorphine. Our goals in this double-blinded randomized controlled clinical trial (RCT) are to investigate the potential of CBD to 1) decrease illicit opioid use and 2) reduce craving.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Randomization will be carried out within each site using stratification factors. Using stratified block randomization with randomly varying block sizes, participants who meet the eligibility requirements and provide informed consent will be randomly allocated to one of the study arms (1 capsule CBD (200 mg), 2 capsules CBD (400 mg), 1 capsule placebo and 2 capsules placebo) with a 1:1:0.5:0.5 allocation ratio. The placebo groups will be combined for statistical analysis purposes. Random permuted blocks sizes within stratification groups will be used to minimize the chance of selection bias.
| Arm | Type | Receives |
|---|---|---|
| 1 capsule CBD (200 mg) | Experimental | Drug: Cannabidiol1 capsule 200 mg CBD 2x per day |
| 2 capsules CBD (400 mg) | Experimental | Drug: Cannabidiol2 capsules 400 mg CBD 2x per day |
| 1 capsule placebo and 2 capsules placebo | Placebo comparator | Drug: Placebo1 capsule 200 mg placebo 2x per day or 2 capsules 400 mg placebo 2x per day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Individuals between 18 and 65 years old.
- Ability to understand and give informed consent.
- Current opioid use disorder (OUD) or OUD in remission while on maintenance therapy with OAT, as determined by DSM-5 with the M.I.N.I. interview (Mini-International Neuropsychiatric Interview).
- Current opioid agonist maintenance treatment with methadone or buprenorphine for at least 14 days prior to consent. With the following more specific criteria for each of these two medications:
Key exclusion criteria (12 listed)
- Participants who are non-English speaking.
- Psychiatric conditions under DSM-5 (examined with the MINI) that would make study participation unsafe, or which would prevent adherence to study procedure; examples include: suicidal (i.e. high risk for suicide on the Columbia suicide severity rating scale (C-SSRS) screen version) or homicidal ideation requiring immediate attention, inadequately-treated mental health disorder (e.g., active psychosis, uncontrolled bipolar disorder).
- Current diagnosis of a severe substance use disorder (except for opioid and nicotine/tobacco) in the past 3 months, based on the MINI interview, that would preclude safe participation in the study as determined by the study medical clinician.
- Signs of acute drug intoxication when arriving at the study site as determined by clinician assessment.
- Medical or psychiatric contraindications for CBD administration (e.g., history of hypersensitivity to cannabinoids); or any of the ingredients in the product (gelatin or sesame oil).
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 |
|---|---|---|
| CannabidiolAlso: CBD1 capsule CBD 200mg | Drug | 1 capsule CBD (200 mg), 2 capsules CBD (400 mg) |
| PlaceboBovine Gel Placebo capsule | Drug | 1 capsule placebo and 2 capsules placebo |
Primary outcome
Percentage of study participants with negative urine toxicology for illicit opioid use
Time frame: 24 weeks
Percentage of study participants with negative urine toxicology for illicit opioid use over the course of 24 weeks.
15 secondary outcomes
Concentration of illicit opioids
Time frame: Duration of the trial, 24 weeks
Weeks of abstinence
Time frame: Duration of the trial, 24 weeks
Use of non-opioid illicit substances
Time frame: Duration of the trial, 24 weeks
Duration of first opioid abstinence
Time frame: Duration of the trial, 24 weeks
Cue-induced Visual Analog Scale for craving (VASC)
Time frame: At 12 and 24-week time points
Cue-induced Visual Analog Scale for anxiety (VASA)
Time frame: At 12 and 24-week time points
Change in illicit opioids in plasma toxicology
Time frame: 24 weeks
Change in illicit opioids in urine toxicology
Time frame: 24 weeks
Study Retention
Time frame: 24 weeks
Opioid Craving Questionnaire (OCQ)
Time frame: Every 4 weeks up to 24 weeks
Generalized Anxiety Disorder Scale (GAD7)
Time frame: Every 4 weeks up to 24 weeks
Substance use other than opioids
Time frame: Duration of the trial, 24 weeks
Methadone plasma concentrations
Time frame: Duration of the trial, 24 weeks
Buprenorphine and metabolite plasma concentrations
Time frame: Duration of the trial, 24 weeks
Retention in opioid agonist therapy
Time frame: Duration of the trial, 24 weeks
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 1 Oct 2026.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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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.
Yasmin Hurd, PhD principal investigator
Icahn School of Medicine at Mount Sinai
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cannabidiol in people with Opioid Use Disorder (OUD), run by Icahn School of Medicine at Mount Sinai at 2 sites 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 6 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 1 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 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Zoe Spieler (929-923-3216, Zoe.Spieler@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of study participants with negative urine toxicology for illicit opioid use (time frame: 24 weeks). 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 1 Oct 2026.