Psilocybin Therapy for Methamphetamine Use Disorder and HIV

Part of paid clinical trials in San Francisco, California.

Sponsor
Nicky Mehtani, MD, MPH
Study ID
NCT07756736
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Human Immunodeficiency Virus (HIV)
  • Methamphetamine Use Disorder

Eligibility Criteria

Sex
ALL
Age
25 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • Psilocybin 5 mg — DRUG
    Single oral 5 mg dose of psilocybin, administered as a capsule under direct observation during a monitored \~8-hour dosing session. Serves as the low-dose active control during the double-blind randomized phase.
  • Psilocybin 25 mg — DRUG
    Single oral 25 mg dose of psilocybin, administered as a capsule under direct clinical observation during a monitored \~8-hour dosing session. Given as the higher dose during the double-blind randomized phase and as the dose used in the optional open-label session.
  • Motivational Support — BEHAVIORAL
    Manualized motivational support delivered by trained facilitators, adapted from the NIAAA Project MATCH MET manual. During the double-blind phase, participants attend 3 preparatory talk therapy sessions before dosing and 3 integration talk therapy sessions after dosing; the optional open-label session is accompanied by an additional 1 preparatory and 3 integration talk therapy sessions before and after the second (open-label) dose. Sessions support rapport, intention-setting, psilocybin psychoeducation and safety, and post-session meaning-making.

Study Details

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

Key Dates

First listed
Aug 11, 2026
Start date
Nov 30, 2026
Status verified
Aug 2026
Primary completion
Apr 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: High-Dose Psilocybin
    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.
  • Active Comparator: Low-Dose Psilocybin
    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.

Primary Outcome Measure

Recruitment Efficiency [ Time Frame: Screening to Baseline (approximately 35 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCSF at Zuckerberg San Francisco General HospitalSan FranciscoCalifornia94110-

Find similar trials in San Francisco, CA

By research site
UCSF at Zuckerberg San Francisco General Hospital· San Francisco, CA

Related Studies