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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

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
Opioid-use Disorder Combination Product: MORE+KAP Behavioral: MORE 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ketamine Assisted Psychotherapy for Opioid Use Disorder
Actual Study Start Date : May 20, 2021
Estimated Primary Completion Date : May 30, 2023
Estimated Study Completion Date : May 30, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

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




Primary Outcome Measures :
  1. Drug use [ Time Frame: From baseline to 3-month follow-up ]
    Days of drug use as measured by the Timeline Followback Procedure


Secondary Outcome Measures :
  1. MOUD use [ Time Frame: From baseline to 3-month follow-up ]
    Days of MOUD use as measured by the Timeline Followback Procedure

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. Theta oscillations [ Time Frame: From baseline to immediately after the 8 week intervention. ]
    Theta oscillations as measured by EEG during meditation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04892251


Contacts
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Contact: Research Coordinator 801-581-3826 eric.garland@socwk.utah.edu

Locations
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United States, Utah
Center on Mindfulness and Integrative Health Intervention Development Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Research Coordinator       KetaMORE@utah.edu   
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Eric L Garland University of Utah
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Responsible Party: Eric Garland, Professor, University of Utah
ClinicalTrials.gov Identifier: NCT04892251    
Other Study ID Numbers: IRB_00130630
First Posted: May 19, 2021    Key Record Dates
Last Update Posted: May 21, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Opioid-Related Disorders
Substance-Related Disorders
Narcotic-Related Disorders
Chemically-Induced Disorders
Mental Disorders