PATH-OUD (Psilocybin-Assisted Therapy for Opioid Use Disorder)
Study Title: PATH-OUD (Psilocybin-Assisted Therapy for Opioid Use Disorder)
Plain Language Summary: We're asking whether psychedelic assisted therapy can help people on methadone or bupenorphrine better manage their non--prescribed opioid use and improve their brain health. We will be taking MRI scans of the brain to map the brain before and after psilocybin. Participants will receive either a high or low dose of psilocybin alongside some sessions with two therapists.
Lead Researcher Name: Prof Adeel Razi, Prof Antonio Verdejo-Garcia, Prof Suresh Sundram, Prof Suzanne Nielsen.
Other Researchers / Team (optional):
Institution / Organization: Monash University
Ethics Approval Number (optional but encouraged): MUREC #47710
Recruitment Start Date: 16 April 2026
Recruitment End Date: 15 April 2027
Trial Phase: Phase 1
Substance Focus: Psilocybin
Therapeutic Model Used : CBT
Is this an RCT?: Yes
Follow-up Psychedelic Dosing Arm Included?: No
Who Can Participate?: Participants aged 18-60 who are on methadone or bupenorphrine for Opioid Dependence and who are taking additional opioids.
Exclusion Criteria: Other substance use disorders, personal or family history of psychosis, seizure history, claustrophobia.
Number of Participants Needed: 36
Location of Participants: State-based
Preferred Participant Demographics: Other
Please Specify: Adults with opioid use disorder
Type of Participation: Other
Please Specify: In person participation
Time Commitment: Two x two hour preparation sessions, half day of imaging and thinking tasks, one full day of dosing, three integration sessions of one hour and a half day of imaging and thinking tasks.
Compensation / Reimbursement: $1500 gift vouchers
Format: In-Person
Technology or Tools Needed: Smartphone
Consent Process Summary: Written consent prior to sessions
Contact Email: path-oud@monash.edu
Phone Number:
Sign-Up / EOI Link : http://www.monash.edu/turner-institute/adeel-razi-lab/path-oud-study/_recache
Website or Social Media Link (optional): http://www.monash.edu/turner-institute/adeel-razi-lab/path-oud-study/_recache
Accessibility Information: Interpreter available, ND-friendly spaces
Cultural Safety Considerations: Trauma-informed, Queer-inclusive
Confidentiality & Privacy Statement: All data de-identified
Study Focus / Topic: PAP
Target Population: Other
Please Specify: People with Opioid Use Disorder
Urgency Level: Seeking Participants Now
Study Methodology Type: Heuristic
Ethics Committee Details: Monash Ethics Committee MUREC #47710
Funding Body / Sponsor (if any): Wellcome Leap
Trial Location: In-Person
Address: 770 Blackburn Road, Clayton VIC 3800, Australia
Trial Start Date:
Trial End Date: 01 May 2027
Link to Official Trial Page: https://www.monash.edu/turner-institute/adeel-razi-lab/path-oud-study/_recache