Back to resultsKetamine Assisted Psychotherapy for Opioid Use Disorder
Primary Purpose
Opioid-use Disorder
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MORE+KAP
MORE
Sponsored by
About this trial
This is an interventional treatment trial for Opioid-use Disorder
Eligibility 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
Sites / Locations
- Center on Mindfulness and Integrative Health Intervention DevelopmentRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MORE+KAP
MORE
Arm Description
8 weeks of Mindfulness-Oriented Recovery Enhancement plus two ketamine assisted psychotherapy sessions
8 weeks of Mindfulness-Oriented Recovery Enhancement
Outcomes
Primary Outcome Measures
Drug use
Days of drug use as measured by the Timeline Followback Procedure
Secondary Outcome Measures
MOUD use
Days of MOUD use as measured by the Timeline Followback Procedure
Emotional Distress
Emotional distress measured by the Depression Anxiety Stress Scale, range from 0 to 63, higher scores indicating worse distress.
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.
Opioid craving
Craving measured by the Desires for Drug Questionnaire, range from 13 to 91, higher scores indicating higher craving.
Self-transcendence
Self-transcendence measured by the Nondual Awareness Dimensional Assessment, range from 13 to 65, higher scores indicating greater self-transcendence.
Affect
Affect measured by Ecological Momentary Assessment, range from 0-10, higher scores indicating more intense affective states.
Mindfulness
Mindfulness measured by the Five Facet Mindfulness Questionnaire, range from 39 to 195, higher scores indicating greater mindfulness.
Reappraisal
Reappraisal measured by the Cognitive Emotion Regulation Questionnaire, range from 4 to 20, higher scores indicating more frequent use of reappraisal.
Savoring
Savoring measured by the Brief Savoring Inventory, range from 4 to 20, higher scores indicating more use of savoring.
Momentary craving
Affect measured by Ecological Momentary Assessment, range from 0-10, higher scores indicating more intense momentary craving.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04892251
Brief Title
Ketamine Assisted Psychotherapy for Opioid Use Disorder
Official Title
Ketamine Assisted Psychotherapy for Opioid Use Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 20, 2021 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
May 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MORE+KAP
Arm Type
Experimental
Arm Description
8 weeks of Mindfulness-Oriented Recovery Enhancement plus two ketamine assisted psychotherapy sessions
Arm Title
MORE
Arm Type
Active Comparator
Arm Description
8 weeks of Mindfulness-Oriented Recovery Enhancement
Intervention Type
Combination Product
Intervention Name(s)
MORE+KAP
Intervention Description
Mindfulness-Oriented Recovery Enhancement plus two sessions where 0.5 to 1.5 mg/kg of ketamine are administered intramuscularly
Intervention Type
Behavioral
Intervention Name(s)
MORE
Intervention Description
Mindfulness-Oriented Recovery Enhancement
Primary Outcome Measure Information:
Title
Drug use
Description
Days of drug use as measured by the Timeline Followback Procedure
Time Frame
From baseline to 3-month follow-up
Secondary Outcome Measure Information:
Title
MOUD use
Description
Days of MOUD use as measured by the Timeline Followback Procedure
Time Frame
From baseline to 3-month follow-up
Title
Emotional Distress
Description
Emotional distress measured by the Depression Anxiety Stress Scale, range from 0 to 63, higher scores indicating worse distress.
Time Frame
From baseline to 3-month follow-up
Title
Meaning in life
Description
Meaning in life measured by the Meaning in Life Questionnaire, Presence Subscale, range from 5 to 35, higher scores indicating more meaning in life.
Time Frame
From baseline to 3-month follow-up
Title
Opioid craving
Description
Craving measured by the Desires for Drug Questionnaire, range from 13 to 91, higher scores indicating higher craving.
Time Frame
From baseline to 3-month follow-up
Title
Self-transcendence
Description
Self-transcendence measured by the Nondual Awareness Dimensional Assessment, range from 13 to 65, higher scores indicating greater self-transcendence.
Time Frame
From baseline to 3-month follow-up
Title
Affect
Description
Affect measured by Ecological Momentary Assessment, range from 0-10, higher scores indicating more intense affective states.
Time Frame
From baseline to 1-month follow-up
Title
Mindfulness
Description
Mindfulness measured by the Five Facet Mindfulness Questionnaire, range from 39 to 195, higher scores indicating greater mindfulness.
Time Frame
From baseline to 3-month follow-up
Title
Reappraisal
Description
Reappraisal measured by the Cognitive Emotion Regulation Questionnaire, range from 4 to 20, higher scores indicating more frequent use of reappraisal.
Time Frame
From baseline to 3-month follow-up
Title
Savoring
Description
Savoring measured by the Brief Savoring Inventory, range from 4 to 20, higher scores indicating more use of savoring.
Time Frame
From baseline to 3-month follow-up
Title
Momentary craving
Description
Affect measured by Ecological Momentary Assessment, range from 0-10, higher scores indicating more intense momentary craving.
Time Frame
From baseline to 1-month follow-up
Other Pre-specified Outcome Measures:
Title
Drug cue-reactivity
Description
Change from baseline in neurophysiological response during lab-based task involving presentation of drug cues designed to measure cue-reactivity.
Time Frame
From baseline to immediately after the 8 week intervention.
Title
Emotion regulation
Description
Change from baseline in neurophysiological response during lab-based task involving presentation of emotional stimuli.
Time Frame
From baseline to immediately after the 8 week intervention.
Title
Theta oscillations
Description
Theta oscillations as measured by EEG during meditation
Time Frame
From baseline to immediately after the 8 week intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Research Coordinator
Phone
801-581-3826
Email
eric.garland@socwk.utah.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric L Garland
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center on Mindfulness and Integrative Health Intervention Development
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Email
KetaMORE@utah.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Ketamine Assisted Psychotherapy for Opioid Use Disorder
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