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)

Center on Mindfulness and Integrative Health Intervention Development

Salt Lake City, Utah, United States

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NCT04892251


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