Psilocybin Therapy for Methamphetamine Use Disorder and HIV (NCT07756736) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Psilocybin Therapy for Methamphetamine Use Disorder and HIV
United States30 participantsStarted 2026-11
Plain-language 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
Who can participate
Age range
25 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 managemen…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recruitment Efficiency
Timeframe: Screening to Baseline (approximately 35 days)
2
Dosing Completion
Timeframe: Baseline to Dosing Visit (approximately 10 days)
3
Retention
Timeframe: Dosing Visit to Visit 9 (approximately 28 days)
4
Acceptability
Timeframe: Visit 9, approximately 38 days
5
Adverse Events
Timeframe: Dosing Visit to Visit 9 (approximately 28 days)