Opioid-use Disorder
Conditions
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.
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.
Interventions
COMBINATION_PRODUCTMORE+KAP
Mindfulness-Oriented Recovery Enhancement plus two sessions where 0.5 to 1.5 mg/kg of ketamine are administered intramuscularly
BEHAVIORALMORE
Mindfulness-Oriented Recovery Enhancement
Sponsors
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Drug use | From baseline to 3-month follow-up | Days of drug use as measured by the Timeline Followback Procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Theta oscillations | From baseline to immediately after the 8 week intervention. | Theta oscillations as measured by EEG during meditation |
| 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. |
Countries
United States
Contacts
Primary ContactResearch Coordinator
Outcome results
None listed