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Ketamine Assisted Psychotherapy for Opioid Use Disorder

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ClinicalTrials.gov Identifier: NCT04892251
Recruitment Status : Recruiting
First Posted : May 19, 2021
Last Update Posted : May 21, 2021
Sponsor:
Information provided by (Responsible Party):
Eric Garland, University of Utah

Tracking Information
First Submitted Date  ICMJE May 10, 2021
First Posted Date  ICMJE May 19, 2021
Last Update Posted Date May 21, 2021
Actual Study Start Date  ICMJE May 20, 2021
Estimated Primary Completion Date May 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2021)
Drug use [ Time Frame: From baseline to 3-month follow-up ]
Days of drug use as measured by the Timeline Followback Procedure
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2021)
  • MOUD use [ Time Frame: From baseline to 3-month follow-up ]
    Days of MOUD use as measured by the Timeline Followback Procedure
  • Emotional Distress [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: From baseline to 1-month follow-up ]
    Affect measured by Ecological Momentary Assessment, range from 0-10, higher scores indicating more intense momentary craving.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 13, 2021)
  • Drug cue-reactivity [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: From baseline to immediately after the 8 week intervention. ]
    Theta oscillations as measured by EEG during meditation
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Ketamine Assisted Psychotherapy for Opioid Use Disorder
Official Title  ICMJE Ketamine Assisted Psychotherapy for Opioid Use Disorder
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Opioid-use Disorder
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: MORE+KAP
    8 weeks of Mindfulness-Oriented Recovery Enhancement plus two ketamine assisted psychotherapy sessions
    Intervention: Combination Product: MORE+KAP
  • Active Comparator: MORE
    8 weeks of Mindfulness-Oriented Recovery Enhancement
    Intervention: Behavioral: MORE
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 13, 2021)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 30, 2023
Estimated Primary Completion Date May 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Research Coordinator 801-581-3826 eric.garland@socwk.utah.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04892251
Other Study ID Numbers  ICMJE IRB_00130630
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Eric Garland, University of Utah
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Utah
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eric L Garland University of Utah
PRS Account University of Utah
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP