Ketamine Assisted Psychotherapy for Opioid Use Disorder
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2021
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2021
CompletedFirst Posted
Study publicly available on registry
May 19, 2021
CompletedStudy Start
First participant enrolled
May 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2024
CompletedJuly 5, 2023
July 1, 2023
2.6 years
May 10, 2021
July 3, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Drug use
Days of drug use as measured by the Timeline Followback Procedure
From baseline to 3-month follow-up
Secondary Outcomes (10)
MOUD use
From baseline to 3-month follow-up
Emotional Distress
From baseline to 3-month follow-up
Meaning in life
From baseline to 3-month follow-up
Opioid craving
From baseline to 3-month follow-up
Self-transcendence
From baseline to 3-month follow-up
- +5 more secondary outcomes
Other Outcomes (3)
Drug cue-reactivity
From baseline to immediately after the 8 week intervention.
Emotion regulation
From baseline to immediately after the 8 week intervention.
Theta oscillations
From baseline to immediately after the 8 week intervention.
Study Arms (2)
MORE+KAP
EXPERIMENTAL8 weeks of Mindfulness-Oriented Recovery Enhancement plus two ketamine assisted psychotherapy sessions
MORE
ACTIVE COMPARATOR8 weeks of Mindfulness-Oriented Recovery Enhancement
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of Opioid Use Disorder
- Receiving OUD treatment with a buprenorphine formulation
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center on Mindfulness and Integrative Health Intervention Development
Salt Lake City, Utah, 84112, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric L Garland
University of Utah
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 10, 2021
First Posted
May 19, 2021
Study Start
May 20, 2021
Primary Completion
December 30, 2023
Study Completion
May 30, 2024
Last Updated
July 5, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share