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Efficacy of Ketamine for the Prevention of Relapse in Patients with Opioid-Use Disorders (OUD)
EU CTIS ID: 2025-520843-34-00
What this study is testing
The primary objective of this study is to evaluate the efficacy of adjunctive ketamine in reducing depressive symptom severity in individuals with opioid use disorder receiving methadone or buprenorphine/naloxone (suboxone) maintenance treatment.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age between 18 to 65 years old
- Currently into maintenance treatment for opioid use disorder
- Patient Health Questionnaire-9 score of ≥ 10
- Primary Care-PTSD-5 Screen ≤ 2
You likely can't join if
- ECG findings showing: Tachycardia, Prior myocardial infarction, Myocardial ischemia, Aberrant conduction
- Hypertension (defined as): Systolic blood pressure > 140 mmHg; or Diastolic blood pressure > 90 mmHg
- Pregnancy (positive urine screen)
- Inaccessible veins for phlebotomy/infusion procedures
- Liver function abnormalities: Baseline alkaline phosphatase > 2.5 times upper limit of normal; Baseline aspartate aminotransferase > 3 times upper limit of normal
- Current bipolar disorder (DSM-5 criteria)
See the full eligibility criteria
- Age between 18 to 65 years old
- Currently into maintenance treatment for opioid use disorder
- Patient Health Questionnaire-9 score of ≥ 10
- Primary Care-PTSD-5 Screen ≤ 2
- ECG findings showing: Tachycardia, Prior myocardial infarction, Myocardial ischemia, Aberrant conduction
- Hypertension (defined as): Systolic blood pressure > 140 mmHg; or Diastolic blood pressure > 90 mmHg
- Pregnancy (positive urine screen)
- Inaccessible veins for phlebotomy/infusion procedures
- Liver function abnormalities: Baseline alkaline phosphatase > 2.5 times upper limit of normal; Baseline aspartate aminotransferase > 3 times upper limit of normal
- Current bipolar disorder (DSM-5 criteria)
- Current or history of psychotic spectrum disorders
- Current or previous recreational use of ketamine or PCP
- Active suicidal ideation (score >4 on item 10 of the MADRS assessment)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.