Targeting Treatment-Resistant OUD With Ketamine-Assisted Mindfulness Oriented Recovery Enhancement

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT07369089
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Opioid Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ketamine — DRUG
    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) — BEHAVIORAL
    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 Group — BEHAVIORAL
    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 Details

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.

Key Dates

Start date
Feb 28, 2026
Status verified
Jan 2026
Primary completion
Jan 31, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
88 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ketamine-Assisted Psychotherapy Plus Mindfulness-Oriented Recovery Enhancement (KetaMORE)
    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.
  • Active Comparator: Ketamine-Assisted Psychotherapy Plus Support Group
    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.

Primary Outcome Measure

Abstinence [ Time Frame: From day 15 through 84. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of California, San DiegoLa JollaCalifornia92093
Hannah Pfeffer, LMSW
[email protected]
619-500-4668
Kelly Hendrickson, MS
[email protected]
Eric Garland, PhD (PRINCIPAL_INVESTIGATOR)
University Of UtahSalt Lake CityUtah84112
Hannah Pfeffer, LMSW
[email protected]
619-500-4668
Benjamin Lewis, PhD (PRINCIPAL_INVESTIGATOR)

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