Ketamine Assisted Psychotherapy for Opioid Use Disorder

Purpose

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

Condition

  • Opioid-use Disorder

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
MORE+KAP 		8 weeks of Mindfulness-Oriented Recovery Enhancement plus two ketamine assisted psychotherapy sessions
  • Combination Product: MORE+KAP
    Mindfulness-Oriented Recovery Enhancement plus two sessions where 0.5 to 1.5 mg/kg of ketamine are administered intramuscularly
Active Comparator
MORE 		8 weeks of Mindfulness-Oriented Recovery Enhancement
  • Combination Product: MORE+KAP
    Mindfulness-Oriented Recovery Enhancement plus two sessions where 0.5 to 1.5 mg/kg of ketamine are administered intramuscularly
  • Behavioral: MORE
    Mindfulness-Oriented Recovery Enhancement

Recruiting Locations

Center on Mindfulness and Integrative Health Intervention Development
Salt Lake City, Utah 84112
Contact:
Research Coordinator
KetaMORE@utah.edu

More Details

Status
Recruiting
Sponsor
University of Utah

Study Contact

Research Coordinator
801-581-3826
eric.garland@socwk.utah.edu

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.