Psilocybin + Counseling for Opioid Use Disorder
Trial Summary
What is the purpose of this trial?
Primary Aim: In participants with OUD, to characterize adverse events associated with adding two psilocybin doses to a stable buprenorphine-naloxone formulation. Secondary Aim: To evaluate the effect of psilocybin treatment on the effectiveness of a buprenorphine-naloxone maintenance therapy. Secondary Aim: To evaluate the effect of concurrent buprenorphine-naloxone use on the effects of psilocybin therapy. Descriptive Aim: To describe any changes in self-efficacy, quality of life, pain.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you must be on a stable dose of buprenorphine-naloxone. If you are currently on methadone or have been on buprenorphine for over four weeks before the study, you cannot participate.
What data supports the effectiveness of psilocybin as a drug for treating Opioid Use Disorder?
Is the combination of psilocybin and counseling safe for treating opioid use disorder?
Buprenorphine, often used in combination with naloxone, is considered safe and effective for treating opioid dependence, with a low potential for abuse. However, there is no specific safety data available for the combination of psilocybin and counseling for opioid use disorder in the provided research.678910
How is the drug Psilocybin + Counseling for Opioid Use Disorder different from other treatments?
Research Team
Randall Brown, MD PhD
Principal Investigator
University of Wisconsin, Madison
Eligibility Criteria
Adults aged 21-65 with opioid use disorder (OUD) who are on a stable buprenorphine-naloxone treatment. Participants must have healthy kidneys, be able to understand English, and agree to use effective contraception. They should not be on methadone, under legal supervision that prohibits study participation, or have certain heart conditions or insulin-dependent diabetes.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Preparatory Counseling
Participants undergo at least 6 hours of preparatory counseling and preparation for psilocybin dosing
Treatment
Participants receive two oral doses of psilocybin, approximately 4 weeks apart, with observation and integration sessions
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and changes in opioid craving
Treatment Details
Interventions
- Buprenorphine (Opioid)
- Psilocybin (Psychedelic)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Wisconsin, Madison
Lead Sponsor
Heffter Research Institute
Collaborator
Etheridge Foundation
Collaborator