Psilocybin Therapy for Methamphetamine Use Disorder and HIV
Key facts
- Where
- San Francisco, United StatesSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 25 and 64 years old?
Source: NCT07756736, who can take part
Where in United States
- UCSF at Zuckerberg San Francisco General HospitalSan Francisco, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Nicky Mehtani, MD, MPH
- Trial code
- NCT07756736
- Record updated
- 9 November 2026
- Original description
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:Read full original descriptionShow less
Psilocybin Recovery Intervention for Stopping Methamphetamine Use
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
Inclusion: 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: Currently taking certain medications that may interact with psilocybin; Recent use of a psychedelic drug; 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; 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.