Clinical trial Recruiting at 1 site Phase1; Phase2 Interventional Ages 18 and up

Ketamine-assisted therapy for opioid addiction

Official title: Ketamine Assisted Psychotherapy for Opioid Use Disorder

Run by University of Utah · NCT04892251 · Data updated 2026-11-12

This study is testing whether adding ketamine to a mindfulness therapy can help people with opioid addiction feel better compared to just the mindfulness therapy alone.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment60 (estimated)
SponsorUniversity of Utah
Academic / other
Locations1 site (Salt Lake City, Utah)
StatusRecruiting
StartedMay 20, 2021
Main results expectedDecember 30, 2023
Study endsMay 30, 2024
Registry record updatedJuly 5, 2023
Trial IDNCT04892251 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are individuals diagnosed with opioid use disorder who are currently receiving treatment with a buprenorphine formulation.

Probably not a fit

Patients with a history of serious mental health issues or those who have previously participated in mindfulness-based interventions may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot clinical trial evaluates the effectiveness of ketamine as an adjunct to a mindfulness-based intervention for individuals with opioid use disorder. The study compares a modified version of the Mindfulness-Oriented Recovery Enhancement (MORE) that includes ketamine (MORE+KAP) against the standard MORE intervention. Participants will be individuals receiving medication for opioid use disorder, such as buprenorphine. The primary goal is to assess improvements in treatment outcomes with MORE+KAP, while the secondary goal focuses on understanding the psychobiological mechanisms involved.

Why it matters

Potential benefit: If successful, this approach could enhance treatment outcomes for patients struggling with opioid use disorder.

How similar studies have gone: While the use of ketamine in addiction treatment is emerging, this specific combination with mindfulness-based interventions is relatively novel and has not been extensively tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

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

Exclusion Criteria:

1. Previous experience with a mindfulness-based intervention program
2. Pregnancy
3. Any serious medical, mental, or cognitive issue that prevents successful participation in a mindfulness-based group treatment program
4. Prior use of ketamine other than as prescribed by a physician
5. 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

Where it's running

  • Center on Mindfulness and Integrative Health Intervention Development
    Salt Lake City, Utah, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.