Opioid Use DisorderPhase 2NCT07369089
Targeting Treatment-Resistant OUD With Ketamine-Assisted Mindfulness Oriented Recovery Enhancement
A Phase 2 study testing Ketamine, Mindfulness-Oriented Recovery Enhancement (MORE) and Support Group in people with Opioid Use Disorder, run by University of California, San Diego at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Ketamine, Mindfulness-Oriented Recovery Enhancement (MORE) and Support Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2026to Apr 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 16Show fewer
- 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)).
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Kelly Hendrickson, MS contact
United States2 sites, 2 recruiting
- Recruiting
University of California, San Diego
La Jolla, California, 92093
Hannah Pfeffer, LMSW, 619-500-4668, hapfeffer@health.ucsd.edu
Kelly Hendrickson, MS, kehendrickson@health.ucsd.edu
- Recruiting
University Of Utah
Salt Lake City, Utah, 84112
Hannah Pfeffer, LMSW, 619-500-4668, hapfeffer@health.ucsd.edu
Gina Gregovitch, Gina.Gregovich@hsc.utah.edu
About this study
Official title: KETAMORE: TARGETING TREATMENT-RESISTANT OUD WITH KETAMINE-ASSISTED MINDFULNESS-ORIENTED RECOVERY ENHANCEMENT
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.
Read the detailed description
This study is a Phase II, two-arm, parallel randomized controlled trial designed to evaluate the efficacy of Mindfulness-Oriented Recovery Enhancement combined with Ketamine-Assisted Psychotherapy (KetaMORE) compared to Ketamine-Assisted Psychotherapy paired with a support group control condition for individuals with opioid use disorder receiving medications for opioid use disorder (MOUD), including buprenorphine.
Participants will be randomized in a 1:1 ratio to one of two conditions: (1) Ketamine-Assisted Psychotherapy combined with Mindfulness-Oriented Recovery Enhancement, or (2) Ketamine-Assisted Psychotherapy combined with a support group providing nonspecific therapeutic support without mindfulness training. Both groups will receive identical ketamine dosing and psychotherapy components; the conditions will differ only in the adjunctive behavioral intervention.
Mindfulness-Oriented Recovery Enhancement is a manualized, evidence-based intervention integrating mindfulness training, cognitive reappraisal, and savoring techniques to reduce craving, negative affect, and maladaptive reward processing associated with substance use. The support group control condition is designed to match therapist contact and group support while excluding mindfulness-based content.
Participants will complete assessments at baseline, during treatment, post-treatment, and follow-up. Primary outcomes will include number of days of opioid use and time to first opioid use lapse. Secondary outcomes will include opioid craving and mood symptoms. Ecological momentary assessments will be used to capture daily fluctuations in substance use, craving, and affect throughout the study period.
- Conditions
- Opioid Use Disorder
- Being tested
- Ketamine, Mindfulness-Oriented Recovery Enhancement (MORE), Support Group
- Keywords
- Mindfulness, Ketamine, Opioid Use disorder
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
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 (MORE)Behavioural
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.
Support GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine-Assisted Psychotherapy Plus Mindfulness-Oriented Recovery Enhancement (KetaMORE) | Experimental | Participants 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. Receives: Drug: Ketamine; Behavioral: Mindfulness-Oriented Recovery Enhancement (MORE) |
| Ketamine-Assisted Psychotherapy Plus Support Group | Active comparator | Participants 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. Receives: Drug: Ketamine; Behavioral: Support Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abstinence
Abstinence as measured by timeline followback and triangulated by drug screen.
Measured: From day 15 through 84.
Secondary outcomes (11)
MOUD discontinuation
Discontinuation of medications for opioid use disorder (MOUD), defined as cessation of prescribed MOUD during the study period using the Timeline Follow-back and biochemically verified use via drug screens.
Measured: From day 15 to 84.
Opioid Craving (Ecological Momentary Assessments)
Opioid craving assessed using ecological momentary assessment (EMA) on a 0-10 numeric rating scale (0=no craving, 10 extreme craving).
Measured: From baseline through week 12.
Opioid Craving (Desires for Drug Questionnaire)
Opioid craving measured using the Desires for Drug Questionnaire (DDQ), a validated self-report measure of desire and urge to use opioids (0= Strongly Disagree, 6= Strongly Agree)
Measured: From baseline to week 12.
Quality of life (WHO-5)
Quality of life assessed using the World Health Organization Five Well-Being Index (WHO-5), a brief measure of subjective psychological well-being. (0= At no time, 5= All of the time)
Measured: From baseline to week 12.
Depressive Symptoms (Patient Health Questionnaire-9)
Depressive symptom severity assessed using the Patient Health Questionnaire-9 (PHQ-9). (0= Not at all, 3= Nearly every day)
Measured: From baseline to week 12.
Post-Traumatic Stress Symptoms (PTSD Checklist for DSM-5)
Post-traumatic stress symptom severity assessed using the PTSD Checklist for DSM-5 (PCL-5). (0 = Not at all, 4= Extremely )
Measured: From baseline to week 12.
Anhedonia (Snaith-Hamilton Pleasure Scale)
Anhedonia assessed using the Snaith-Hamilton Pleasure Scale (SHAPS), a validated measure of reduced capacity to experience pleasure. (1=Strongly Disagree, 4= Strongly Agree)
Measured: From baseline to week 12.
Psychological Distress (Depression Anxiety Stress Scales)
Psychological distress assessed using the Depression Anxiety Stress Scales (DASS). (0= Did not apply to me at all, 3= Applied to me very much or most of the time)
Measured: From baseline to week 12.
Positive and Negative Affect (Positive and Negative Affect Schedule)
Positive and negative affect assessed using the Positive and Negative Affect Schedule (PANAS). (1= Very slightly or not at all, 5= Extremely)
Measured: From baseline to week 12.
Pain (PEG Scale)
Pain severity and pain-related interference assessed using the PEG scale. (0= no pain or interference, 10= Worst imaginable pain or interference)
Measured: Baseline to week 12.
Momentary affective state
Momentary affective state measured by EMA on 0-10 numeric rating scale (0=low affect, 10=high affect).
Measured: Baseline through week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start1 Jul 2026
- Primary completionJan 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- University of Utah
- Responsible party
- Principal investigator, Eric Garland, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07369089
- Sponsor's protocol ID
- 177164
- Status last verified
- Nov 2026
- First submitted
- 23 Jan 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-Identified participant data will be shared for approved purposes with assigned data access agreement (i.e., meta-analysis)
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KETAMORE: TARGETING TREATMENT-RESISTANT OUD WITH KETAMINE-ASSISTED MINDFULNESS-ORIENTED RECOVERY ENHANCEMENT
- ClinicalTrials.gov ID
- NCT07369089
- Acronym / sponsor ID
- 177164
- Conditions
- Opioid Use Disorder
- Keywords
- Mindfulness, Ketamine, Opioid Use disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- University of Utah
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a Phase II, two-arm, parallel randomized controlled trial designed to evaluate the efficacy of Mindfulness-Oriented Recovery Enhancement combined with Ketamine-Assisted Psychotherapy (KetaMORE) compared to Ketamine-Assisted Psychotherapy paired with a support group control condition for individuals with opioid use disorder receiving medications for opioid use disorder (MOUD), including buprenorphine.
Participants will be randomized in a 1:1 ratio to one of two conditions: (1) Ketamine-Assisted Psychotherapy combined with Mindfulness-Oriented Recovery Enhancement, or (2) Ketamine-Assisted Psychotherapy combined with a support group providing nonspecific therapeutic support without mindfulness training. Both groups will receive identical ketamine dosing and psychotherapy components; the conditions will differ only in the adjunctive behavioral intervention.
Mindfulness-Oriented Recovery Enhancement is a manualized, evidence-based intervention integrating mindfulness training, cognitive reappraisal, and savoring techniques to reduce craving, negative affect, and maladaptive reward processing associated with substance use. The support group control condition is designed to match therapist contact and group support while excluding mindfulness-based content.
Participants will complete assessments at baseline, during treatment, post-treatment, and follow-up. Primary outcomes will include number of days of opioid use and time to first opioid use lapse. Secondary outcomes will include opioid craving and mood symptoms. Ecological momentary assessments will be used to capture daily fluctuations in substance use, craving, and affect throughout the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine-Assisted Psychotherapy Plus Mindfulness-Oriented Recovery Enhancement (KetaMORE) | Experimental | Drug: Ketamine, Behavioral: Mindfulness-Oriented Recovery Enhancement (MORE)Participants 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 comparator | Drug: Ketamine, Behavioral: Support GroupParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (16 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetamineKetamine 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. | Drug | Ketamine-Assisted Psychotherapy Plus Mindfulness-Oriented Recovery Enhancement (KetaMORE), Ketamine-Assisted Psychotherapy Plus Support Group |
| Mindfulness-Oriented Recovery Enhancement (MORE)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. | Behavioural | Ketamine-Assisted Psychotherapy Plus Mindfulness-Oriented Recovery Enhancement (KetaMORE) |
| Support GroupThe 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. | Behavioural | Ketamine-Assisted Psychotherapy Plus Support Group |
Primary outcome
Abstinence
Time frame: From day 15 through 84.
Abstinence as measured by timeline followback and triangulated by drug screen.
11 secondary outcomes
MOUD discontinuation
Time frame: From day 15 to 84.
Opioid Craving (Ecological Momentary Assessments)
Time frame: From baseline through week 12.
Opioid Craving (Desires for Drug Questionnaire)
Time frame: From baseline to week 12.
Quality of life (WHO-5)
Time frame: From baseline to week 12.
Depressive Symptoms (Patient Health Questionnaire-9)
Time frame: From baseline to week 12.
Post-Traumatic Stress Symptoms (PTSD Checklist for DSM-5)
Time frame: From baseline to week 12.
Anhedonia (Snaith-Hamilton Pleasure Scale)
Time frame: From baseline to week 12.
Psychological Distress (Depression Anxiety Stress Scales)
Time frame: From baseline to week 12.
Positive and Negative Affect (Positive and Negative Affect Schedule)
Time frame: From baseline to week 12.
Pain (PEG Scale)
Time frame: Baseline to week 12.
Momentary affective state
Time frame: Baseline through week 12.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: Yes. De-Identified participant data will be shared for approved purposes with assigned data access agreement (i.e., meta-analysis)
Related trials for Opioid Use Disorder
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Active, not recruitingPhase 2
Wellcome Leap Psilocybin for OUD
Opioid Use Disorder
Recruiting
Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial
Opioid Use Disorder, Opioid Misuse
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kelly Hendrickson, MS contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ketamine, Mindfulness-Oriented Recovery Enhancement (MORE) and Support Group in people with Opioid Use Disorder, run by University of California, San Diego at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hannah Pfeffer, LMSW (619-500-4668, hapfeffer@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abstinence (time frame: From day 15 through 84.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.