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Not yet recruitingPhase 2

Psilocybin Therapy for Methamphetamine Use Disorder and HIV

NCT07756736 · PRISM · Nicky Mehtani, MD, MPH

Closed to entry
Status
Not accepting participants
Phase 2
Phase
30
Target enrolment
1
Study sites
1 US states

What it is testing

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

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Recruitment Efficiency

    Measured over Screening to Baseline (approximately 35 days)

  • Dosing Completion

    Measured over Baseline to Dosing Visit (approximately 10 days)

  • Retention

    Measured over Dosing Visit to Visit 9 (approximately 28 days)

  • Acceptability

    Measured over Visit 9, approximately 38 days

  • Adverse Events

    Measured over Dosing Visit to Visit 9 (approximately 28 days)

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

25 Years to 64 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Age 25 to 64 * Diagnosed with HIV at least 3 months ago * Moderate-to-severe methamphetamine use disorder * Uses methamphetamine regularly and identifies it as their primary drug * Has a goal of quitting methamphetamine use * Able and willing to abstain from methamphetamine and other non-prescribed drugs for at least 24 hours prior to and throughout psilocybin dosing sessions * Currently living indoors with stable housing anticipated for the duration of the study * Has a text-capable cellphone * Willing to use highly effective contraception and not donate sperm throughout the study * Able to participate in study procedures in English Exclusion Criteria: * History of any primary psychotic disorder (e.g., schizophrenia or schizoaffective disorder), bipolar I disorder, or certain other psychiatric conditions as determined by study assessment * Current moderate-to-severe opioid, alcohol, or sedative use disorder (Note: people on stable doses of buprenorphine or methadone may be eligible) * Currently taking certain medications that may interact with psilocybin * Recent use of a psychedelic drug * Certain significant heart, liver, or kidney conditions * Uncontrolled high blood presure (i.e., \>150/90 mmHg) * History of stroke or seizure in the past year * Current pregnancy or breastfeeding * Current involvement in the criminal legal system that would be expected to interfere with study participation * Current or planned enrollment in a contingency management program or another investigational substance use treatment trial within the past month Note: Additional eligibility criteria apply. Certain criteria and thresholds are not listed here to preserve the scientific integrity of the study.

Where

1 study site

FacilityCityRegionCountry
UCSF at Zuckerberg San Francisco General HospitalSan FranciscoCaliforniaUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT07756736 on ClinicalTrials.gov →

Last updated in the registry 2026-08-11. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits