Targeting Treatment-Resistant OUD With Ketamine-Assisted Mindfulness Oriented Recovery Enhancement
KETAMORE: TARGETING TREATMENT-RESISTANT OUD WITH KETAMINE-ASSISTED MINDFULNESS-ORIENTED RECOVERY ENHANCEMENT
1 other identifier
interventional
88
1 country
2
Brief Summary
The goal of this clinical trial is to examine the usefulness of Mindfulness-Oriented Recovery Enhancement combined with Ketamine-Assisted Psychotherapy (KetaMORE) for individuals with opioid use disorder who are receiving medication treatment. The main question it aims to answer is whether individuals with opioid use disorder who receive Mindfulness-Oriented Recovery Enhancement in combination with Ketamine-Assisted Psychotherapy will demonstrate greater reductions in opioid use and craving than individuals who receive Ketamine-Assisted Psychotherapy with a non-mindfulness support group. Participants will be randomly assigned to receive either Mindfulness-Oriented Recovery Enhancement combined with Ketamine-Assisted Psychotherapy or Ketamine-Assisted Psychotherapy combined with a support group control condition. Researchers will compare these groups on days of opioid use, time to first opioid use lapse, craving, and mood, assessed using ecological momentary assessments and standardized measures collected during treatment and follow-up.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2026
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2026
CompletedFirst Posted
Study publicly available on registry
January 27, 2026
CompletedStudy Start
First participant enrolled
February 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
February 3, 2026
January 1, 2026
1.9 years
January 23, 2026
January 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Abstinence
Abstinence as measured by timeline followback and triangulated by drug screen.
From day 15 through 84.
Secondary Outcomes (11)
MOUD discontinuation
From day 15 to 84.
Opioid Craving (Ecological Momentary Assessments)
From baseline through week 12.
Opioid Craving (Desires for Drug Questionnaire)
From baseline to week 12.
Quality of life (WHO-5)
From baseline to week 12.
Depressive Symptoms (Patient Health Questionnaire-9)
From baseline to week 12.
- +6 more secondary outcomes
Study Arms (2)
Ketamine-Assisted Psychotherapy Plus Mindfulness-Oriented Recovery Enhancement (KetaMORE)
EXPERIMENTALParticipants assigned to this arm will receive ketamine-assisted psychotherapy combined with Mindfulness-Oriented Recovery Enhancement (MORE). MORE is delivered as a structured, manualized behavioral intervention designed to reduce opioid use by targeting craving, negative affect, and maladaptive reward processing through mindfulness training, cognitive reappraisal, and savoring techniques.
Ketamine-Assisted Psychotherapy Plus Support Group
ACTIVE COMPARATORParticipants assigned to this arm will receive ketamine-assisted psychotherapy combined with a support group intervention. The support group provides nonspecific therapeutic support and group discussion but does not include mindfulness training or structured skills from Mindfulness-Oriented Recovery Enhancement.
Interventions
Ketamine will be administered as part of ketamine-assisted psychotherapy under medical supervision according to the study protocol. Ketamine dosing and administration procedures will be identical across study arms.
Mindfulness-Oriented Recovery Enhancement is a manualized, evidence-based intervention integrating mindfulness practices, cognitive reappraisal, and savoring exercises to reduce craving, improve emotional regulation, and support recovery from opioid use disorder. MORE sessions are delivered in a group format and coordinated with ketamine-assisted psychotherapy sessions.
The support group intervention consists of therapist-led group sessions focused on emotional support and discussion of recovery-related experiences. This condition is designed to match the MORE intervention in duration and therapist contact while excluding mindfulness-based or structured skills training.
Eligibility Criteria
You may qualify if:
- English-speaking .
- DSM-5 criteria for Opioid Use Disorder (OUD).
- Documented evidence (by urine toxicology) of current illicit drug use (upon screening) or by self-report on the Addiction Severity Index (ASI).
- Men/Women \>/= 18
- Current prescription of a buprenorphine-containing product.
- 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.).
- Agreement to adhere to Lifestyle Considerations
You may not qualify if:
- \. A primary DSM-5 Axis I diagnosis of schizophrenia, schizoaffective disorder, dissociative identity disorder, or bipolar I/II disorder as determined by psychiatric evaluation.
- \. 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.
- \. 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.
- \. 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.
- \. 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).
- \. 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:
- Any significant liver diseases or symptoms of liver disease regardless of liver enzyme levels.
- Asymptomatic alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>=5x upper limit of normal (ULN).
- Symptomatic ALT or AST \>= 2x ULN.
- AST/ALT \>3 upper limit of normal (ULN)
- Total bilirubin \> 1.5x ULN (Gilbert syndrome is allowed).
- Alkaline phosphatase (ALP) \>2x ULN.
- 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)).
- \. 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.
- \. 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, San Diegolead
- University of Utahcollaborator
Study Sites (2)
University of California, San Diego
La Jolla, California, 92093, United States
University Of Utah
Salt Lake City, Utah, 84112, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Psychiatry
Study Record Dates
First Submitted
January 23, 2026
First Posted
January 27, 2026
Study Start
February 1, 2026
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
April 1, 2028
Last Updated
February 3, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data will be available after publication of the primary, secondary, and mechanistic outcomes of the trial.
- Access Criteria
- Data will be available with a signed data access agreement
De-Identified participant data will be shared for approved purposes with assigned data access agreement (i.e., meta-analysis)