Ketamine Assisted Psychotherapy for Opioid Use Disorder

  • End date
    May 30, 2023
  • participants needed
  • sponsor
    University of Utah
Updated on 31 May 2021


This pilot clinical trial aims to assess the preliminary efficacy of ketamine as an adjunct for a mindfulness-based intervention for opioid use disorder.


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.

Condition Opioid Use Disorder
Clinical Study IdentifierNCT04892251
SponsorUniversity of Utah
Last Modified on31 May 2021


Yes No Not Sure

Inclusion Criteria

Diagnosis of Opioid Use Disorder
Receiving OUD treatment with a buprenorphine formulation

Exclusion Criteria

Previous experience with a mindfulness-based intervention program
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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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