Ketamine for Opioid Use Disorder
Purpose
The goal of this clinical trial is to learn if ketamine works to reduce craving for opioids in adults entering methadone treatment for opioid use disorder. The main questions it aims to answer are: - Does ketamine reduce craving for opioids in patients with opioid use disorder? - Does ketamine reduce symptoms of opioid withdrawal such as depression, pain, and poor sleep quality? - Do patients who take ketamine stay in methadone treatment longer, and/or have better treatment outcomes than those given the placebo? Researchers will compare ketamine to an active placebo (a look-alike substance that contains a drug that does not do anything to help the condition it is supposed to treat but will mimic some of the side effects of ketamine) to see if ketamine works to reduce craving for opioids in adults entering methadone treatment for opioid use disorder. Participants will: - Be given ketamine or a placebo 4 times over a period of 2 weeks - Visit the clinic weekly and monthly for checkups and tests for 90 days post-intake
Condition
- Opioid Use Disorder
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Age 18 to 65 years old 2. Recent history (most recent 2 weeks prior to clinic intake) of routine use of illicit opioids, 5+ times/week 3. Fulfillment of DSM-5/ICD-10 criteria for moderate-to-severe opioid use disorder 4. Acceptance into methadone treatment for opioid use disorder within the past 14 days at the time of screening.
Exclusion Criteria
- Routine use of prescribed medications for OUD (5+ days/week) for longer than the 14 days leading up to clinic intake. Source: Self-report, H&P 2. Recent prescribed or illicit benzodiazepine, ketamine, or PCP use that exceeds 5+ days/week for the last 3 months. Source: H&P 3. Pregnant and/or breastfeeding. Source: UDS, H&P 4. Stage 4 Hypertension, defined by a systolic blood pressure (SBP) > 180 mmHg or a diastolic blood pressure (DBP) > 120 mmHg. Source: H&P 5. Clinically significant abnormal findings for which study participation is deemed unsafe. Source: H&P 6. Severe mental illness or psychiatric disorder for which study participation is deemed unsafe (except for depression, PTSD, and substance use disorder). Source: H&P 7. **Severe hepatic impairment (baseline alkaline phosphatase or aspartate aminotransferase > 5 times the upper limit of normal. Source: Labs - NOTE: Due to time constraints in the study design, exclusion criterion #7 does not need to be met before the initial consent to participate. This criterion only needs to be established prior to the first esketamine/placebo session. This will allow us to enroll participants as soon as possible, giving more time and flexibility to complete the baseline/weekly assessments before the first esketamine/placebo session. Individuals that are initially enrolled and subsequently do not qualify due to severe hepatic impairment will be considered screen failures and withdrawn from the protocol.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Treatment with Ketamine |
Individuals will receive four doses spaced 1-6 days apart of 0.75mg/kg of intramuscular ketamine (n=25) over a period of two weeks. |
|
|
Placebo Comparator Treatment with Placebo |
Individuals will receive four doses spaced 1-6 days apart of an intramuscular active placebo (diphenhydramine, 50 mg) (n=25) over a period of two weeks. |
|
Recruiting Locations
Baltimore 4347778, Maryland 4361885 21201
More Details
- Status
- Recruiting
- Sponsor
- University of Maryland, Baltimore