Psilocybin Therapy for Methamphetamine Use Disorder and HIV (PRISM)

August 5, 2026 updated by: Nicky Mehtani, MD, MPH

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94110
        • UCSF at Zuckerberg San Francisco General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: High-Dose Psilocybin
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.
Drug: Psilocybin 25 mg
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.
Behavioral: Motivational Support
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.
Other Names:
  • Motivational Enhancement Therapy (MET)
Active Comparator: Low-Dose Psilocybin
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.
Drug: Psilocybin 25 mg
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.
Behavioral: Motivational Support
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.
Other Names:
  • Motivational Enhancement Therapy (MET)
Drug: Psilocybin 5 mg
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recruitment Efficiency
Time Frame: Screening to Baseline (approximately 35 days)
Proportion of participants who undergo in-person screening who are fully enrolled in the study and initiate treatment.
Screening to Baseline (approximately 35 days)
Dosing Completion
Time Frame: Baseline to Dosing Visit (approximately 10 days)
Proportion of enrolled participants who receive psilocybin dosing.
Baseline to Dosing Visit (approximately 10 days)
Retention
Time Frame: Dosing Visit to Visit 9 (approximately 28 days)
Proportion of participants receiving psilocybin who complete the end-of-double-blind-period study visit.
Dosing Visit to Visit 9 (approximately 28 days)
Acceptability
Time Frame: Visit 9, approximately 38 days
Scores on an end-of-treatment acceptability questionnaire.
Visit 9, approximately 38 days
Adverse Events
Time Frame: Dosing Visit to Visit 9 (approximately 28 days)
Number of participants who experience treatment-emergent adverse events between initial psilocybin dosing and the end-of-double-blind-period visit.
Dosing Visit to Visit 9 (approximately 28 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Methamphetamine Use (TLFB)
Time Frame: Baseline to Visit 9 (approximately 38 days)
Change from baseline in self-reported past-month days of methamphetamine use, assessed by Timeline Followback (TLFB), at Day 28 post-dose.
Baseline to Visit 9 (approximately 38 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nicky Mehtani, MD, MPH

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nicky J. Mehtani, MD, MPH, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 11, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1DP2DA066200 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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