Psilocybin for Methamphetamine Addiction and HIV/AIDS
(PRISM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this clinical trial is to learn whether it is possible to use psilocybin in combination with motivational support therapy to treat moderate-to-severe methamphetamine use disorder (MeUD) in people with HIV who are seeking to stop using methamphetamine. The main questions it aims to answer are:
* Do people with HIV and MeUD find psilocybin with motivational support therapy feasible and acceptable as a potential treatment?
* Is psilocybin safe and tolerable among people with HIV and MeUD?
Participants will:
* Be randomly assigned to receive a single monitored dose of either 25 mg (higher dose) or 5 mg (lower dose) psilocybin
* Have 3 preparation and 3 integration motivational support therapy visits before and after the psilocybin dosing session.
* Report their methamphetamine use prior to, during, and up to 3 months following the intervention
* Optionally receive one additional open-label 25 mg psilocybin session after the 4-week assessment, if eligible
Who Is on the Research Team?
Nicky J. Mehtani, MD, MPH
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants receive a single oral dose of 25 mg psilocybin (PEX010) during a blinded 8-hour dosing visit, delivered within a manualized motivational support framework of 3 preparatory and 3 integration therapy sessions before and after dosing. After 4 weeks following the dosing session, eligible participants may receive a second optional open-label 25 mg psilocybin session with additional preparatory and integration support.
Participants receive a single oral dose of 5 mg psilocybin (PEX010) during a blinded 8-hour dosing visit, delivered within a manualized motivational support framework of 3 preparatory and 3 integration therapy sessions before and after dosing. After 4 weeks following the dosing session, eligible participants may receive an optional open-label 25 mg psilocybin session with additional preparatory and integration support.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nicky Mehtani, MD, MPH
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.