Ketamine Assisted Psychotherapy for Opioid Use Disorder

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

Study Overview

• Status: Recruiting
• Conditions: Opioid-use Disorder
• Intervention / Treatment: Combination product: MORE+KAP; Behavioral: MORE

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Research Coordinator; Phone Number: 801-581-3826; Email: eric.garland@socwk.utah.edu

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Recruiting
      • Center on Mindfulness and Integrative Health Intervention Development
      • Contact: Research Coordinator; Email: KetaMORE@utah.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Behavioral: MORE; Mindfulness-Oriented Recovery Enhancement

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug cue-reactivity	Change from baseline in neurophysiological response during lab-based task involving presentation of drug cues designed to measure cue-reactivity.	From baseline to immediately after the 8 week intervention.
Emotion regulation	Change from baseline in neurophysiological response during lab-based task involving presentation of emotional stimuli.	From baseline to immediately after the 8 week intervention.
Theta oscillations	Theta oscillations as measured by EEG during meditation	From baseline to immediately after the 8 week intervention.

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Eric L Garland, University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2021
• Primary Completion (Estimated): December 30, 2023
• Study Completion (Estimated): May 30, 2024

Study Registration Dates

• First Submitted: May 10, 2021
• First Submitted That Met QC Criteria: May 13, 2021
• First Posted (Actual): May 19, 2021

Study Record Updates

• Last Update Posted (Actual): July 5, 2023
• Last Update Submitted That Met QC Criteria: July 3, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Narcotic-Related Disorders; Substance-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: IRB_00130630

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes