NCT07756736Not yet recruitingPhase 2
Psilocybin Therapy for Methamphetamine Use Disorder and HIV
Psilocybin Recovery Intervention for Stopping Methamphetamine Use
Source: ClinicalTrials.gov · Last updated 11 Aug 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 5 Aug 2026
- Start date
- Nov 2026
- Primary completion date
- Apr 2029
- Lead sponsor
- Nicky Mehtani, MD, MPH
- Diseases
- HIV
- NCT number
- NCT07756736
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From Nov 2026 to the primary completion date, Apr 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently taking certain medications that may interact with psilocybin
- Recent use of a psychedelic drug
Other illness
- 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)
- Certain significant heart, liver, or kidney conditions
- History of stroke or seizure in the past year
Other
- Uncontrolled high blood presure (i.e., \>150/90 mmHg)
- 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.
Who the study is looking for
- 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
Age in the registry: 25 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UCSF at Zuckerberg San Francisco General Hospital Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.