Ketamine-assisted therapy for opioid addiction
Ketamine Assisted Psychotherapy for Opioid Use Disorder
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
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Utah Academic / other |
| Locations | 1 site (Salt Lake City, Utah) |
| Trial ID | NCT04892251 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with opioid use disorder who are currently receiving treatment with a buprenorphine formulation.
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.
Why it matters
Potential benefit: If successful, this approach could enhance treatment outcomes for patients struggling with opioid use disorder.
How similar studies have performed: 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.
Eligibility criteria
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 this trial is running
Salt Lake City, Utah
- Center on Mindfulness and Integrative Health Intervention Development — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Principal investigator: Eric L Garland — University of Utah
- Study coordinator: Research Coordinator
- Email: eric.garland@socwk.utah.edu
- Phone: 801-581-3826
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.