Status:
RECRUITING
Ketamine Assisted Psychotherapy for Opioid Use Disorder
Lead Sponsor:
University of Utah
Conditions:
Opioid-use Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 o...
Eligibility Criteria
Inclusion
- Diagnosis of Opioid Use Disorder
- Receiving OUD treatment with a buprenorphine formulation
Exclusion
- 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
Key Trial Info
Start Date :
May 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04892251
Start Date
May 20 2021
End Date
May 30 2024
Last Update
July 5 2023
Active Locations (1)
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1
Center on Mindfulness and Integrative Health Intervention Development
Salt Lake City, Utah, United States, 84112