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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MORE+KAP | Experimental | 8 weeks of Mindfulness-Oriented Recovery Enhancement plus two ketamine assisted psychotherapy sessions |
|
| MORE | Active Comparator | 8 weeks of Mindfulness-Oriented Recovery Enhancement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MORE+KAP | Combination Product | Mindfulness-Oriented Recovery Enhancement plus two sessions where 0.5 to 1.5 mg/kg of ketamine are administered intramuscularly |
|
| Measure | Description | Time Frame |
|---|---|---|
| Drug use | Days of drug use as measured by the Timeline Followback Procedure | From baseline to 3-month follow-up |
| 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. |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Research Coordinator | Contact | 801-581-3826 | eric.garland@socwk.utah.edu |
| Name | Affiliation | Role |
|---|---|---|
| Eric L Garland | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center on Mindfulness and Integrative Health Intervention Development | Recruiting | Salt Lake City | Utah | 84112 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 26, 2025 | Apr 14, 2025 | 3 |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| MORE | Behavioral | Mindfulness-Oriented Recovery Enhancement |
|
| 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 |
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. |