Ketamine Assisted Psychotherapy for Opioid Use Disorder
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Drug use [From baseline to 3-month follow-up]
Days of drug use as measured by the Timeline Followback Procedure
Secondary Outcome Measures
- MOUD use [From baseline to 3-month follow-up]
Days of MOUD use as measured by the Timeline Followback Procedure
- Emotional Distress [From baseline to 3-month follow-up]
Emotional distress measured by the Depression Anxiety Stress Scale, range from 0 to 63, higher scores indicating worse distress.
- Meaning in life [From baseline to 3-month follow-up]
Meaning in life measured by the Meaning in Life Questionnaire, Presence Subscale, range from 5 to 35, higher scores indicating more meaning in life.
- Opioid craving [From baseline to 3-month follow-up]
Craving measured by the Desires for Drug Questionnaire, range from 13 to 91, higher scores indicating higher craving.
- Self-transcendence [From baseline to 3-month follow-up]
Self-transcendence measured by the Nondual Awareness Dimensional Assessment, range from 13 to 65, higher scores indicating greater self-transcendence.
- Affect [From baseline to 1-month follow-up]
Affect measured by Ecological Momentary Assessment, range from 0-10, higher scores indicating more intense affective states.
- Mindfulness [From baseline to 3-month follow-up]
Mindfulness measured by the Five Facet Mindfulness Questionnaire, range from 39 to 195, higher scores indicating greater mindfulness.
- Reappraisal [From baseline to 3-month follow-up]
Reappraisal measured by the Cognitive Emotion Regulation Questionnaire, range from 4 to 20, higher scores indicating more frequent use of reappraisal.
- Savoring [From baseline to 3-month follow-up]
Savoring measured by the Brief Savoring Inventory, range from 4 to 20, higher scores indicating more use of savoring.
- Momentary craving [From baseline to 1-month follow-up]
Affect measured by Ecological Momentary Assessment, range from 0-10, higher scores indicating more intense momentary craving.
Other Outcome Measures
- Drug cue-reactivity [From baseline to immediately after the 8 week intervention.]
Change from baseline in neurophysiological response during lab-based task involving presentation of drug cues designed to measure cue-reactivity.
- Emotion regulation [From baseline to immediately after the 8 week intervention.]
Change from baseline in neurophysiological response during lab-based task involving presentation of emotional stimuli.
- Theta oscillations [From baseline to immediately after the 8 week intervention.]
Theta oscillations as measured by EEG during meditation
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosis of Opioid Use Disorder
-
Receiving OUD treatment with a buprenorphine formulation
Exclusion Criteria:
-
Previous experience with a mindfulness-based intervention program
-
Pregnancy
-
Any serious medical, mental, or cognitive issue that prevents successful participation in a mindfulness-based group treatment program
-
Prior use of ketamine other than as prescribed by a physician
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Center on Mindfulness and Integrative Health Intervention Development | Salt Lake City | Utah | United States | 84112 |
Sponsors and Collaborators
- University of Utah
Investigators
- Principal Investigator: Eric L Garland, University of Utah
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB_00130630