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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

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.