Ketamine Assisted Psychotherapy for Opioid Use Disorder
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- University of Utah
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Drug use
Study Overview
Brief Summary
This pilot clinical trial aims to assess the preliminary efficacy of ketamine as an adjunct for a mindfulness-based intervention for opioid use disorder.
Detailed Description
The purpose of this study is to conduct a Stage 1 randomized controlled trial to test a potential optimization of the evidence-based Mindfulness-Oriented Recovery Enhancement (MORE) intervention for opioid use disorder (OUD). Here we will add Ketamine to MORE (MORE+KAP) and test the MORE+KAP intervention versus the standard MORE intervention in a sample of patients receiving medications for OUD (MOUD; e.g, buprenorphine). The primary aim to is evaluate the extent to which MORE+KAP improves OUD treatment relative to MORE. The secondary aim is to identify the psychobiological mediators of MORE+KAP.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of Opioid Use Disorder
- •Receiving OUD treatment with a buprenorphine formulation
Exclusion Criteria
- •Previous experience with a mindfulness-based intervention program
- •Any serious medical, mental, or cognitive issue that prevents successful participation in a mindfulness-based group treatment program
- •Prior use of ketamine other than as prescribed by a physician
- •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
Outcomes
Primary Outcomes
Drug use
Time Frame: From baseline to 3-month follow-up
Days of drug use as measured by the Timeline Followback Procedure
Secondary Outcomes
- Meaning in life(From baseline to 3-month follow-up)
- Opioid craving(From baseline to 3-month follow-up)
- Self-transcendence(From baseline to 3-month follow-up)
- Affect(From baseline to 1-month follow-up)
- Reappraisal(From baseline to 3-month follow-up)
- MOUD use(From baseline to 3-month follow-up)
- Emotional Distress(From baseline to 3-month follow-up)
- Mindfulness(From baseline to 3-month follow-up)
- Savoring(From baseline to 3-month follow-up)
- Momentary craving(From baseline to 1-month follow-up)
Investigators
Eric Garland
Professor
University of Utah