Ketamine Assisted Psychotherapy for Opioid Use Disorder

Study Overview
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Brief Summary
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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
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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.

Official Title
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Ketamine Assisted Psychotherapy for Opioid Use Disorder

Conditions
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Opioid-use Disorder

Intervention / Treatment
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* Combination Product: MORE+KAP
* Behavioral: MORE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Opioid Use Disorder Receiving OUD treatment with a buprenorphine formulation Exclusion Criteria: Previous experience with a mindfulness-based intervention program Pregnancy 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MORE+KAP<br>8 weeks of Mindfulness-Oriented Recovery Enhancement plus two ketamine assisted psychotherapy sessions | Combination Product: MORE+KAP<br>* Mindfulness-Oriented Recovery Enhancement plus two sessions where 0.5 to 1.5 mg/kg of ketamine are administered intramuscularly<br>|
| Active Comparator: MORE<br>8 weeks of Mindfulness-Oriented Recovery Enhancement | Behavioral: MORE<br>* Mindfulness-Oriented Recovery Enhancement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug use | Days of drug use as measured by the Timeline Followback Procedure | From baseline to 3-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MOUD use | Days of MOUD use as measured by the Timeline Followback Procedure | From baseline to 3-month follow-up | 
| Emotional Distress | Emotional distress measured by the Depression Anxiety Stress Scale, range from 0 to 63, higher scores indicating worse distress. | From baseline to 3-month follow-up | 
| Meaning in life | Meaning in life measured by the Meaning in Life Questionnaire, Presence Subscale, range from 5 to 35, higher scores indicating more meaning in life. | From baseline to 3-month follow-up | 
| Opioid craving | Craving measured by the Desires for Drug Questionnaire, range from 13 to 91, higher scores indicating higher craving. | From baseline to 3-month follow-up | 
| Self-transcendence | Self-transcendence measured by the Nondual Awareness Dimensional Assessment, range from 13 to 65, higher scores indicating greater self-transcendence. | From baseline to 3-month follow-up | 
| Affect | Affect measured by Ecological Momentary Assessment, range from 0-10, higher scores indicating more intense affective states. | From baseline to 1-month follow-up | 
| Mindfulness | Mindfulness measured by the Five Facet Mindfulness Questionnaire, range from 39 to 195, higher scores indicating greater mindfulness. | From baseline to 3-month follow-up | 
| Reappraisal | Reappraisal measured by the Cognitive Emotion Regulation Questionnaire, range from 4 to 20, higher scores indicating more frequent use of reappraisal. | From baseline to 3-month follow-up | 
| Savoring | Savoring measured by the Brief Savoring Inventory, range from 4 to 20, higher scores indicating more use of savoring. | From baseline to 3-month follow-up | 
| Momentary craving | Affect measured by Ecological Momentary Assessment, range from 0-10, higher scores indicating more intense momentary craving. | From baseline to 1-month follow-up |