Opioid Use DisorderPhase 2NCT06111339
Ketamine for OUD and Suicidal Ideation in the ED
A Phase 2 study testing Ketamine and Saline Solution in people with Opioid Use Disorder and Suicidal Ideation, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This is a pilot, double-blind, placebo-controlled randomized clinical trial of individuals with opioid use disorder (OUD) with suicidal ideation in the emergency department (ED) to receive either a single infusion of ketamine 0.8mg/kg (n=25) or saline placebo (n=25). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder, Suicidal Ideation
- What is being tested?
- Ketamine and Saline Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2024to 31 Mar 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible, individuals must be/have:
- English speaking adults aged 18 and above
- Diagnosed with DSM5 opioid use disorder, moderate or severe, or clinically suspected opioid use disorder
- Endorsing suicidal ideation sufficiently severe to meet criteria for referral to an inpatient psychiatric facility or a crisis stabilization unit
- Any prior history of an opioid overdose
- Medically cleared
Show all 27Show fewer
- Individuals with any of the following will be excluded:
- Any psychotic disorder or active homicidally
- Inability to perform consent due to impaired mental status
- Current substance intoxication or current (or within the past 1-month) mania, hypomania, mixed-episode, or psychosis
- Systolic blood pressure persistently elevated above 160mmHg, diastolic blood pressure greater than 100 mmHg, or heart rate >100bmp, in the ED
- Clinical Opioid Withdrawal Scale (COWS) score of 12 or greater
- History of hypersensitivity to ketamine, or experience of emergence reaction
- History of hypersensitivity to ondansetron or concurrently using apomorphine
- History of any illicit or recreational use of ketamine in the past 12 months
- Receipt of ketamine treatment for depression in the past 3 months
- History of DSM5 hallucinogen use disorder, intracranial mass or bleed, porphyria, thyrotoxicosis, seizure disorder other than from alcohol withdrawal, liver cirrhosis, or sleep apnea
- Cardiac or EKG abnormalities based on history, physical examination or the baseline EKG
- History within 6 months of thoracic surgery, lung cancer, head trauma, stroke, or myocardial infarction
- Liver dysfunction with LFTs >3x upper normal limit
- Current use of medications with known drug-drug interactions with ketamine (i.e., St. John's Wort, theophylline, opioid analgesics other than buprenorphine and methadone for the treatment OUD, Central Nervous System (CNS) depressants other than benzodiazepines or phenobarbital)
- Pregnant
- Patients who are breastfeeding
- ASA class 3 or greater or documented history of difficult airway in HER
- Active exacerbation of COPD or asthma
- Currently participating or anticipated to participate in a concurrent investigational clinical trial
- High risk for adverse emotional or behavioral reaction based on the opinion of the study investigators, including evidence of a personality disorder
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Ketamine for the Treatment for Opioid Use Disorder and Suicidal Ideation in the Emergency Department
This is a pilot, double-blind, placebo-controlled randomized clinical trial of individuals with opioid use disorder (OUD) with suicidal ideation in the emergency department (ED) to receive either a single infusion of ketamine 0.8mg/kg (n=25) or saline placebo (n=25). The primary aim is to evaluate the safety of the ketamine treatment. The secondary aim is to determine the preliminary efficacy of opioid- and suicide-related outcomes.
Read the detailed description
Individuals with opioid use disorder (OUD) seeking medical care in the emergency department (ED) will be first evaluated as per usual clinical care by the ED staff, including any acute medical treatment for overdose or any other acute medical issues needing treatment. For those who endorse suicidal ideation, after medical clearance, the standard medical care will involve the evaluation of patients by the psychiatry consult service in the ED. Patients evaluated by psychiatry who require further behavioral health care and do not have acute medical issues remain in the ED awaiting admission to an inpatient psychiatry unit or other linkages to care. Potential participants will be approached after the psychiatry evaluation is complete and a decision has been made to keep the patients in the ED for continued psychiatric care or admit them medically. After applying the full inclusion and exclusion criteria, those who remain eligible will be randomized to receive in a double-blind fashion either a single infusion of ketamine (0.8mg/kg) or a saline placebo. Safety assessments will be conducted during and after the receipt of ketamine or placebo, and at follow-up assessments after discharge from the emergency department of the hospital following inpatient psychiatric treatment.
- Conditions
- Opioid Use Disorder, Suicidal Ideation
- Being tested
- Ketamine, Saline Solution
- Medical subject headings
- Opioid-Related Disorders, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
The intervention will consist of a single infusion of ketamine in the ED at a dose of 0.8mg/kg over 40 minutes.
Saline SolutionOther
The placebo will be a 0.9% saline solution administered over 40 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Experimental | This arm will receive ketamine (n=25) Receives: Drug: Ketamine |
| Saline Placebo | Placebo comparator | This arm will receive the saline placebo (n=25) Receives: Other: Saline Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower Suicidal Ideation
For suicidal ideation, the Columbia Suicide Severity Rating Scale (C-SSRS), which is a 5-item tool, will be used to assess suicidal ideation.
Measured: 7-day remote follow up; 14- day remote follow up; 28 days after being discharged from inpatient unit or emergency department.
Less Illicit Opioid Use
For illicit opioid use, the outcome is the proportion of abstinent days during the 28-day period after discharge from the ED or the inpatient psychiatric unit, assessed using the self-report Timeline Follow Back (TLFB). The TLFB is a gold-standard calendar method to assess substance use in the prior 28 days.
Measured: 28 days after being discharged from inpatient unit or emergency department.
Incidence of Serious Adverse Events (SAE)
The primary safety outcome is the incidence of serious adverse events (SAE) defined as hypertensive urgency (SBP>180mmHg or DBP>110mmHg) or tachycardia (HR>130bmp). Vital signs will be monitored throughout the ketamine administration.
Measured: From the beginning on the infusion, every 15 minutes throughout infusion, and at the end of the infusion.
Secondary outcomes (9)
Opioid Withdrawal
Opioid withdrawal will be measured using the Clinical Opioid Withdrawal Scale (COWS). Scoring: 5-12 = mild 13-24 = moderate 25-36 = moderately severe >36 = severe withdrawal
Measured: Assessed daily while the participant remains in the ED, starting with the day that the ketamine/placebo infusion occurs until the discharge date.
Days to Relapse
Days to Relapse will be assessed using the self-report Timeline Follow Back (TLFB). The TLFB is a gold-standard calendar method to assess substance use in the prior 28 days.
Measured: 7-day remote follow up; 14- day remote follow up; 28 days after being discharged from inpatient unit or emergency department.
Percentage of Addiction Treatment Engagement
Evaluating whether the patient is engaged or not in treatment, such as meeting their primary care physician or addiction specialist.
Measured: 28 days after being discharged from inpatient unit or emergency department.
Urine Toxicology Result for Ketamine
The urine drug screen result (positive or negative) for ketamine will be assessed.
Measured: 28 days after being discharged from inpatient unit or emergency department.
Urine Toxicology Result for Opioids
The urine drug screen result (positive or negative) for opioids will be assessed.
Measured: 28 days after being discharged from inpatient unit or emergency department.
Emergence of Psychiatric Adverse Effects
The CADSS is a scale with 6 subject-rated items. Items are divided into 3 components-depersonalization, derealization, and amnesia.
Measured: 28 days after being discharged from inpatient unit or emergency department.
Emergence of Psychiatric Adverse Effects
The PRISE is a patient self-report tool used to qualify side effects in the following domains: gastrointestinal, heart, skin, nervous system, eyes/ears, genital/urinary, sleep, sexual functioning, and other. Each domain has multiple symptoms which can be endorsed. For each domain the patient rates whether the symptoms are tolerable or distressing
Measured: 28 days after being discharged from inpatient unit or emergency department.
Craving for Opioids
The Opioid Craving Questionnaire (3-item scale) will assess opioid craving. Each question assesses opioid craving with answer choices ranging from 0 (not at all) to 10 (extremely strong) or 0 (not at all) to 10 (I'm sure I would use opiates). A higher score for each question indicates higher opioid cravings.
Measured: 7-day remote follow up; 14- day remote follow up; 28 days after being discharged from inpatient unit or emergency department.
Craving for Ketamine
The Ketamine Craving Questionnaire (3-item scale) will assess ketamine craving. Each question assesses ketamine craving with answer choices ranging from 0 (not at all) to 10 (extremely strong) or 0 (not at all) to 10 (I'm sure I would use ketamine). A higher score for each question indicates higher ketamine cravings.
Measured: 7-day remote follow up; 14- day remote follow up; 28 days after being discharged from inpatient unit or emergency department.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start14 Jun 2024
- Primary completion11 Mar 2025
- Study completion31 Mar 2025
Why it stopped: Low recruitment numbers and study funding will be closing shortly.
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.
- More trials run by Brigham and Women's HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joji Suzuki, MD, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06111339
- Sponsor's protocol ID
- 2023P002857
- Status last verified
- Apr 2025
- First submitted
- 19 Oct 2023
- Last updated
- 8 Apr 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine for the Treatment for Opioid Use Disorder and Suicidal Ideation in the Emergency Department
- ClinicalTrials.gov ID
- NCT06111339
- Acronym / sponsor ID
- 2023P002857
- Conditions
- Opioid Use Disorder, Suicidal Ideation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment numbers and study funding will be closing shortly.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 14 Jun 2024 (actual)
- Primary completion
- 11 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 1 Nov 2023 (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.
This is a pilot, double-blind, placebo-controlled randomized clinical trial of individuals with opioid use disorder (OUD) with suicidal ideation in the emergency department (ED) to receive either a single infusion of ketamine 0.8mg/kg (n=25) or saline placebo (n=25). The primary aim is to evaluate the safety of the ketamine treatment. The secondary aim is to determine the preliminary efficacy of opioid- and suicide-related outcomes.
Detailed description
Individuals with opioid use disorder (OUD) seeking medical care in the emergency department (ED) will be first evaluated as per usual clinical care by the ED staff, including any acute medical treatment for overdose or any other acute medical issues needing treatment. For those who endorse suicidal ideation, after medical clearance, the standard medical care will involve the evaluation of patients by the psychiatry consult service in the ED. Patients evaluated by psychiatry who require further behavioral health care and do not have acute medical issues remain in the ED awaiting admission to an inpatient psychiatry unit or other linkages to care. Potential participants will be approached after the psychiatry evaluation is complete and a decision has been made to keep the patients in the ED for continued psychiatric care or admit them medically. After applying the full inclusion and exclusion criteria, those who remain eligible will be randomized to receive in a double-blind fashion either a single infusion of ketamine (0.8mg/kg) or a saline placebo. Safety assessments will be conducted during and after the receipt of ketamine or placebo, and at follow-up assessments after discharge from the emergency department of the hospital following inpatient psychiatric treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Experimental | Drug: KetamineThis arm will receive ketamine (n=25) |
| Saline Placebo | Placebo comparator | Other: Saline SolutionThis arm will receive the saline placebo (n=25) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- English speaking adults aged 18 and above
- Diagnosed with DSM5 opioid use disorder, moderate or severe, or clinically suspected opioid use disorder
- Endorsing suicidal ideation sufficiently severe to meet criteria for referral to an inpatient psychiatric facility or a crisis stabilization unit
- Any prior history of an opioid overdose
- Medically cleared
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| KetamineThe intervention will consist of a single infusion of ketamine in the ED at a dose of 0.8mg/kg over 40 minutes. | Drug | Ketamine |
| Saline SolutionThe placebo will be a 0.9% saline solution administered over 40 minutes. | Other | Saline Placebo |
Primary outcome
Lower Suicidal Ideation
Time frame: 7-day remote follow up; 14- day remote follow up; 28 days after being discharged from inpatient unit or emergency department.
For suicidal ideation, the Columbia Suicide Severity Rating Scale (C-SSRS), which is a 5-item tool, will be used to assess suicidal ideation.
Less Illicit Opioid Use
Time frame: 28 days after being discharged from inpatient unit or emergency department.
For illicit opioid use, the outcome is the proportion of abstinent days during the 28-day period after discharge from the ED or the inpatient psychiatric unit, assessed using the self-report Timeline Follow Back (TLFB). The TLFB is a gold-standard calendar method to assess substance use in the prior 28 days.
Incidence of Serious Adverse Events (SAE)
Time frame: From the beginning on the infusion, every 15 minutes throughout infusion, and at the end of the infusion.
The primary safety outcome is the incidence of serious adverse events (SAE) defined as hypertensive urgency (SBP>180mmHg or DBP>110mmHg) or tachycardia (HR>130bmp). Vital signs will be monitored throughout the ketamine administration.
9 secondary outcomes
Opioid Withdrawal
Time frame: Assessed daily while the participant remains in the ED, starting with the day that the ketamine/placebo infusion occurs until the discharge date.
Days to Relapse
Time frame: 7-day remote follow up; 14- day remote follow up; 28 days after being discharged from inpatient unit or emergency department.
Percentage of Addiction Treatment Engagement
Time frame: 28 days after being discharged from inpatient unit or emergency department.
Urine Toxicology Result for Ketamine
Time frame: 28 days after being discharged from inpatient unit or emergency department.
Urine Toxicology Result for Opioids
Time frame: 28 days after being discharged from inpatient unit or emergency department.
Emergence of Psychiatric Adverse Effects
Time frame: 28 days after being discharged from inpatient unit or emergency department.
Emergence of Psychiatric Adverse Effects
Time frame: 28 days after being discharged from inpatient unit or emergency department.
Craving for Opioids
Time frame: 7-day remote follow up; 14- day remote follow up; 28 days after being discharged from inpatient unit or emergency department.
Craving for Ketamine
Time frame: 7-day remote follow up; 14- day remote follow up; 28 days after being discharged from inpatient unit or emergency department.
Results and safety
The study was stopped early (reason given: Low recruitment numbers and study funding will be closing shortly.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ketamine and Saline Solution in people with Opioid Use Disorder and Suicidal Ideation, run by Brigham and Women's Hospital 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 27 inclusion and 0 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: stopped early, as of the sponsor's last update on 8 Apr 2025. 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. 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 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?
The study was stopped early (reason given: Low recruitment numbers and study funding will be closing shortly.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower Suicidal Ideation (time frame: 7-day remote follow up; 14- day remote follow up; 28 days after being discharged from inpatient unit or emergency department.). The study lists 3 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 8 Apr 2025.