Ketamine Assisted Psychotherapy for Opioid Use Disorder

Phase 1

Recruiting

• Conditions: Opioid-use Disorder
• Interventions: Combination Product: MORE+KAP; Behavioral: MORE

• Registration Number: NCT04892251
• Lead Sponsor: University of Utah

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 Timeline

• Study First Submitted: 2021-05-10
• Study First Submitted QC: 2021-05-13
• Study First Posted: 2021-05-19
• Study Start: 2021-05-20
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-03
• Last Update Posted: 2023-07-05
• Primary Completion: 2023-12-30
• Study Completion: 2024-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MORE+KAP	MORE+KAP	8 weeks of Mindfulness-Oriented Recovery Enhancement plus two ketamine assisted psychotherapy sessions
MORE	MORE	8 weeks of Mindfulness-Oriented Recovery Enhancement

Primary Outcome Measures

Name	Time	Method
Drug use	From baseline to 3-month follow-up	Days of drug use as measured by the Timeline Followback Procedure

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Center on Mindfulness and Integrative Health Intervention Development; 🇺🇸 Salt Lake City, Utah, United States