Psilocybin Therapy for Methamphetamine Use Disorder and HIV

Summary

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

Conditions

• Methamphetamine Use Disorder
• Human Immunodeficiency Virus (HIV)

Interventions

DRUG

Psilocybin 5 mg

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.

DRUG

Psilocybin 25 mg

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.

BEHAVIORAL

Motivational Support

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.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• Nicky Mehtani, MD, MPH

  lead OTHER

Principal Investigators

• Nicky J. Mehtani, MD, MPH · University of California, San Francisco

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

25 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-11-30

Primary Completion

2029-04-30

Completion

2029-06-30

FDA Drug

Yes

Countries

• United States

Study Locations