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NCT Number: NCT07756736

Psilocybin Therapy for Methamphetamine Use Disorder and HIV

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

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Key information

Conditions

Methamphetamine Use Disorder Acquired Immunodeficiency Syndrome Amphetamine-Related Disorders Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Genital Diseases HIV Infections Human Immunodeficiency Virus (HIV) Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Disorders RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Substance-Related Disorders Urogenital Diseases Virus Diseases

Age range

25 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UCSF at Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Psilocybin 5 mg

Drug

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 mg

Drug

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 support

Behavioral

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)

Primary outcomes

  1. 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.

  2. Dosing Completion

    Time frame: Baseline to Dosing Visit (approximately 10 days)

    Proportion of enrolled participants who receive psilocybin dosing.

  3. 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.

  4. Acceptability

    Time frame: Visit 9, approximately 38 days

    Scores on an end-of-treatment acceptability questionnaire.

  5. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Eliza Banbury, BA

CONTACT

[email protected]

510-985-3522

Sponsors and collaborators

Lead sponsor

Nicky Mehtani, MD, MPH

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Psilocybin Recovery Intervention for Stopping Methamphetamine Use

Acronym: PRISM

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 11, 2026
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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