Can ketamine and mindfulness break the grip of opioid addiction?
NCT ID NCT07369089
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether combining ketamine-assisted psychotherapy with mindfulness training (called KetaMORE) helps people with opioid use disorder who are already on medication. 88 participants will be randomly assigned to receive either KetaMORE or ketamine with a support group. Researchers will track opioid use, cravings, and mood to see if the mindfulness approach leads to better outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ketamine
- What this could lead to
- If successful, this could offer a new treatment option for people with opioid use disorder who haven't responded to standard medications.
- What could go wrong
- This is a small, early-stage trial (88 participants) and may not show a clear benefit. Ketamine can cause side effects like dissociation and nausea, and the results may not apply to everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 88 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. English-speaking . 2. DSM-5 criteria for Opioid Use Disorder (OUD). 3. Documented evidence (by urine toxicology) of current illicit drug use (upon screening) or by self-report on the Addiction Severity Index (ASI). 4. Men/Women \>/= 18 5. Current prescription of a buprenorphine-containing product. 6. Have a support person that would be able to escort the subject home on the evening of the ketamine dosing session. The use of ride services will not be permitted (e.g., Uber, Lift, taxi, etc.). 7. Agreement to adhere to Lifestyle Considerations Exclusion Criteria: * 1\. A primary DSM-5 Axis I diagnosis of schizophrenia, schizoaffective disorder, dissociative identity disorder, or bipolar I/II disorder as determined by psychiatric evaluation. 2\. Has baseline hypertension (≥160 SBP or ≥100 DBP), after repeated measurements. Note: Participants with hypertension that has been controlled by medication down to \<160 Systolic blood pressure (SBP) and \<100 diastolic blood pressure (DBP) will be allowed participate. 3\. Has baseline abnormal resting heart rate (\>100 or \<60). 4. History of cardiovascular disease, including but not limited to clinically significant coronary artery disease, cardiac hypertrophy, cardiac ischemia, congestive heart failure, myocardial infarction, angina pectoris, coronary artery bypass graft or artificial heart valve, stroke, transient ischemic attack, or any clinically significant arrhythmia. 5\. Has QTcf \>450msec for men or women on EKG. Note: Participants may qualify for the study if QTc 450-480 msec on one EKG, but then \<=450 msec on repeat EKG. If QT-prolonging medications are started or increased in dose after enrollment and prior to ketamine administration, a repeat EKG must be done \>12-hours after this change in order to assure continued safe enrollment in the trial. 6\. Active suicidal intent or suicidal or non-suicidal self-injurious behaviors, as defined by a "yes" response to question 4 on C-SSRS within the past 6 months at screening or prior to dosing (Active Suicidal Ideation with Some Intent to Act, with or without Specific Plan). 7\. Suicidal behaviors within the last 6 month. 8. History of allergy or hypersensitivity reaction to ketamine. 9. History of ketamine use disorder. 10. History of intracranial bleeding or stroke. 11. Current intracranial mass. 12. Seizure within the last 6 months prior to screening visit. 13. Baseline oxygen saturation \<95%. 14. Current significant liver disease. 15. Meets the following laboratory parameters: 1. Any significant liver diseases or symptoms of liver disease regardless of liver enzyme levels. 2. Asymptomatic alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>=5x upper limit of normal (ULN). 3. Symptomatic ALT or AST \>= 2x ULN. 4. AST/ALT \>3 upper limit of normal (ULN) 5. Total bilirubin \> 1.5x ULN (Gilbert syndrome is allowed). 6. Alkaline phosphatase (ALP) \>2x ULN. 7. Renal insufficiency (i.e., estimated glomerular filtration rate (eGFR) \< 30 milliliter/minute (mL/min) /1.73 m\^2 (using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine Equation), Creatinine Clearance (CrCl) \< 30 mL/min (using the Cockcroft-Gault Equation), or current dialysis)). 16\. Currently pregnant or breastfeeding. 17. Has uncontrolled insulin-dependent diabetes and has had a hospitalization for diabetes-related complication within 6 months of signing ICF. 18\. Diagnosed cognitive impairments, including dementia, mild cognitive impairment, traumatic brain injury, or developmental delays, that would prevent the participant from completing the study protocol, as identified by self-disclosure when asked in eligibility screening question. 19\. Individuals prescribed monoamine oxidase inhibitors.(see Appendix 1) 20. Individuals prescribed medications that are CYP2B6 inhibitors or inducers (see Appendix 1) 21. Patients taking \>2 mg of lorazepam-equivalents per day.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University Of Utah
Salt Lake City, Utah, 84112, United States
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University of California, San Diego
La Jolla, California, 92093, United States
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