Methamphetamine Use DisorderPhase 2PRISMNCT07756736
Psilocybin Therapy for Methamphetamine Use Disorder and HIV
A Phase 2 study testing Psilocybin 5 mg, Psilocybin 25 mg and Motivational Support in people with Methamphetamine Use Disorder and Human Immunodeficiency Virus (HIV), run by Nicky Mehtani, MD, MPH at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 64 years
- Conditions the study is for
- Methamphetamine Use Disorder, Human Immunodeficiency Virus (HIV)
- What is being tested?
- Psilocybin 5 mg, Psilocybin 25 mg and Motivational Support
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Jun 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UCSF at Zuckerberg San Francisco General Hospital
San Francisco, California, 94110
About this study
Official title: 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?
Read more
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
- Being tested
- Psilocybin 5 mg, Psilocybin 25 mg, Motivational Support
- Keywords
- methamphetamine use disorder, HIV, methamphetamine, psilocybin, amphetamine-related disorders, stimulant use disorder, people with HIV, psychedelics, psychedelic-assisted therapy
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Amphetamine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psilocybin 5 mgDrug
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.
Psilocybin 25 mgDrug
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.
Motivational SupportBehavioural
Also called Motivational Enhancement Therapy (MET)
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.
| Study group | Role | What they receive |
|---|---|---|
| High-Dose Psilocybin | Experimental | Participants receive a single oral dose of 25 mg psilocybin (PEX010) during a blinded 8-hour dosing visit, delivered within a manualized motivational support framework of 3 preparatory and 3 integration therapy sessions before and after dosing. After 4 weeks following the dosing session, eligible participants may receive a second optional open-label 25 mg psilocybin session with additional preparatory and integration support. Receives: Drug: Psilocybin 25 mg; Behavioral: Motivational Support |
| Low-Dose Psilocybin | Active comparator | Participants receive a single oral dose of 5 mg psilocybin (PEX010) during a blinded 8-hour dosing visit, delivered within a manualized motivational support framework of 3 preparatory and 3 integration therapy sessions before and after dosing. After 4 weeks following the dosing session, eligible participants may receive an optional open-label 25 mg psilocybin session with additional preparatory and integration support. Receives: Drug: Psilocybin 5 mg; Drug: Psilocybin 25 mg; Behavioral: Motivational Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Efficiency
Proportion of participants who undergo in-person screening who are fully enrolled in the study and initiate treatment.
Measured: Screening to Baseline (approximately 35 days)
Dosing Completion
Proportion of enrolled participants who receive psilocybin dosing.
Measured: Baseline to Dosing Visit (approximately 10 days)
Retention
Proportion of participants receiving psilocybin who complete the end-of-double-blind-period study visit.
Measured: Dosing Visit to Visit 9 (approximately 28 days)
Acceptability
Scores on an end-of-treatment acceptability questionnaire.
Measured: Visit 9, approximately 38 days
Adverse Events
Number of participants who experience treatment-emergent adverse events between initial psilocybin dosing and the end-of-double-blind-period visit.
Measured: Dosing Visit to Visit 9 (approximately 28 days)
Secondary outcomes (1)
Methamphetamine Use (TLFB)
Change from baseline in self-reported past-month days of methamphetamine use, assessed by Timeline Followback (TLFB), at Day 28 post-dose.
Measured: Baseline to Visit 9 (approximately 38 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study startNov 2026 (estimated)
- Primary completionApr 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nicky Mehtani, MD, MPH
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Nicky Mehtani, MD, MPH, University of California, San Francisco
- Investigators
- Nicky J. Mehtani, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07756736
- Sponsor's protocol ID
- 1DP2DA066200
- Other IDs
- 1DP2DA066200
- Acronym
- PRISM
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No