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Ketamine Assisted Psychotherapy for Opioid Use Disorder

Phase 1 & 2
Recruiting
Led By Eric L Garland
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Receiving OUD treatment with a buprenorphine formulation
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 3-month follow-up
Awards & highlights

Study Summary

This trial will test whether adding ketamine to a mindfulness-based intervention can help people with opioid use disorder.

Who is the study for?
This trial is for individuals currently treated with buprenorphine for opioid use disorder. Participants must not be pregnant or breastfeeding, have severe heart conditions, seizures, need oxygen support, significant liver disease, history of stroke or intracranial bleeding, certain psychiatric disorders like dissociative identity disorder or psychosis, and no prior allergic reactions to ketamine.Check my eligibility
What is being tested?
The study is testing the effectiveness of Ketamine Assisted Psychotherapy (KAP) combined with a mindfulness-based intervention called MORE against just the mindfulness program alone in treating opioid addiction.See study design
What are the potential side effects?
Potential side effects may include disorientation or confusion during ketamine administration, elevated blood pressure and heart rate changes. There might also be temporary mood alterations and rare allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am currently being treated for opioid use disorder with a buprenorphine-based medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 3-month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 3-month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Drug use
Secondary outcome measures
Affect
Emotional Distress
MOUD use
+7 more
Other outcome measures
Drug cue-reactivity
Emotion regulation
Theta oscillations

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: MORE+KAPExperimental Treatment1 Intervention
8 weeks of Mindfulness-Oriented Recovery Enhancement plus two ketamine assisted psychotherapy sessions
Group II: MOREActive Control1 Intervention
8 weeks of Mindfulness-Oriented Recovery Enhancement

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,091 Previous Clinical Trials
1,732,502 Total Patients Enrolled
Eric L GarlandPrincipal InvestigatorUniversity of Utah

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit of participation for this clinical research endeavor?

"Indeed, according to clinicaltrials.gov this research study is still seeking participants who meet the criteria. The trial was first announced on May 20th 2021 and has since been updated once - also on that day. 60 volunteers are needed for a single medical centre location."

Answered by AI

Are there any vacancies left for participants in this trial?

"Clinicaltrials.gov confirms that this clinical trial continues to search for participants and has been unstintingly active since its inception on May 20th 2021, with the last edit also taking place on the same date."

Answered by AI

Who else is applying?

What site did they apply to?
Center on Mindfulness and Integrative Health Intervention Development
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

Have had no luck with traditional treatment programs and I'm hoping there's another option somewhere.
PatientReceived no prior treatments
~16 spots leftby Mar 2025