Ketamine Assisted Psychotherapy for Opioid Use Disorder

Phase 2RecruitingNCT04892251

University of Utah60 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Opioid-use Disorder

Interventions

MORE+KAPCOMBINATION_PRODUCT

Mindfulness-Oriented Recovery Enhancement plus two sessions where 0.5 to 1.5 mg/kg of ketamine are administered intramuscularly

MOREBEHAVIORAL

Mindfulness-Oriented Recovery Enhancement

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Center on Mindfulness and Integrative Health Intervention Development

Salt Lake City, Utah, United States

RECRUITING