Ketamine Assisted Psychotherapy for Opioid Use Disorder

IRB_00130630

This pilot clinical trial aims to assess the preliminary efficacy of ketamine as an adjunct for a mindfulness-based intervention for opioid use disorder.

2021-05-20

2023-12-30

2024-05-30

Recruiting

Early phase I

60

Inclusion Criteria: 1. Diagnosis of Opioid Use Disorder 2. Receiving OUD treatment with a buprenorphine formulation Exclusion Criteria: 1. Previous experience with a mindfulness-based intervention program 2. Pregnancy 3. Any serious medical, mental, or cognitive issue that prevents successful participation in a mindfulness-based group treatment program 4. Prior use of ketamine other than as prescribed by a physician 5. Any of the following medical conditions Blood Vessel Disease Heart Valve Disease Heart Failure Class 2 or Above Heart Disease Pregnancy/Breastfeeding Arteriovenous Malformation History of Intracranial Bleeding or Stroke History of Seizures Hypoxia defined by current need for supplemental oxygen Liver Disease History of allergic reaction to Ketamine Dementia (moderate-severe) History of Psychotic Disorder, Bipolar Disorder, or Personality Disorder Dissociative Identity Disorder

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

2023-07-05