Ketamine Assisted Psychotherapy for Opioid Use Disorder

Opioid-use Disorder Clinical Trial

Official title:

Ketamine Assisted Psychotherapy for Opioid Use Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04892251
• Other study ID #: IRB_00130630
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 20, 2021
• Est. completion date: May 30, 2024

Study information

• Verified date: July 2023
• Source: University of Utah
• Contact: Research Coordinator
• Phone: 801-581-3826
• Email: eric.garland[@]socwk.utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Opioid-use Disorder
• Substance-Related Disorders

Intervention

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

Locations

Country	Name	City	State
United States	Center on Mindfulness and Integrative Health Intervention Development	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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.
Other	Theta oscillations	Theta oscillations as measured by EEG during meditation	From baseline to immediately after the 8 week intervention.
Primary	Drug use	Days of drug use as measured by the Timeline Followback Procedure	From baseline to 3-month follow-up
Secondary	MOUD use	Days of MOUD use as measured by the Timeline Followback Procedure	From baseline to 3-month follow-up
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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