RecruitingPhase 1Phase 2NCT04892251
Ketamine Assisted Psychotherapy for Opioid Use Disorder
Sponsor
University of Utah
Enrollment
60 participants
Start Date
May 20, 2021
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria2
- Diagnosis of Opioid Use Disorder
- Receiving OUD treatment with a buprenorphine formulation
Exclusion Criteria6
- 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
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Interventions
COMBINATION_PRODUCTMORE+KAP
Mindfulness-Oriented Recovery Enhancement plus two sessions where 0.5 to 1.5 mg/kg of ketamine are administered intramuscularly
BEHAVIORALMORE
Mindfulness-Oriented Recovery Enhancement
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04892251
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