Ketamine + Mindfulness Therapy for Opioid Use Disorder

Not yet recruiting at 1 trial location
HP
KH
Overseen ByKelly Hendrickson, MS
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of California, San Diego
Must be taking: Buprenorphine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for individuals with opioid use disorder who are currently on medication treatment but still struggle with dependence. Participants should be interested in a therapy combining mindfulness techniques and ketamine-assisted psychotherapy. Specific eligibility details aren't provided, so it's best to contact the study team for more information.

Inclusion Criteria

English-speaking
Meets DSM-5 criteria for Opioid Use Disorder (OUD)
I am currently taking medication that contains buprenorphine.
See 4 more

Exclusion Criteria

Has QTcf >450msec for men or women on EKG (exceptions apply)
Is currently pregnant or breastfeeding
Has a baseline oxygen saturation <95%
See 17 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Mindfulness-Oriented Recovery Enhancement combined with Ketamine-Assisted Psychotherapy or Ketamine-Assisted Psychotherapy with a support group control condition

12 weeks
Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Ketamine
  • Mindfulness-Oriented Recovery Enhancement (MORE)

Trial Overview

The trial is testing if Mindfulness-Oriented Recovery Enhancement (MORE) combined with Ketamine-Assisted Psychotherapy can better reduce opioid use and cravings compared to just Ketamine-Assisted Psychotherapy with a support group. Participants will be randomly placed into one of these two groups.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Ketamine-Assisted Psychotherapy Plus Mindfulness-Oriented Recovery Enhancement (KetaMORE)Experimental Treatment2 Interventions
Group II: Ketamine-Assisted Psychotherapy Plus Support GroupActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials
1,215
Recruited
1,593,000+

University of Utah

Collaborator

Trials
1,169
Recruited
1,623,000+