Recruiting
Phase 2

Psilocybin & Motivational Support Therapy

Sponsor:

Nicky Mehtani, MD, MPH

Code:

NCT07756736

Conditions

Methamphetamine Use Disorder

Human Immunodeficiency Virus (HIV)

Eligibility Criteria

Sex: All

Age: 25 - 64

Healthy Volunteers: Not accepted

Interventions

Psilocybin 5 mg

Psilocybin 25 mg

Motivational Support

Study Details

Brief 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

Conditions

Methamphetamine Use Disorder

Human Immunodeficiency Virus (HIV)

Study ID

NCT07756736

Start date

Dec, 2026

Status verified date

Nov, 2026

Completion date

Jun, 2029

Anticipated

Primary completion date

Apr, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 64

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

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.

Primary outcome measure

  • Recruitment Efficiency [ Time Frame: Screening to Baseline (approximately 35 days) ]
  • Dosing Completion [ Time Frame: Baseline to Dosing Visit (approximately 10 days) ]
  • Retention [ Time Frame: Dosing Visit to Visit 9 (approximately 28 days) ]
  • Acceptability [ Time Frame: Visit 9, approximately 38 days ]
  • Adverse Events [ Time Frame: Dosing Visit to Visit 9 (approximately 28 days) ]

Central Contacts and Locations

Central contacts

Eliza Banbury, BA

510-985-3522prism.trial@ucsf.edu

Locations

UCSF at Zuckerberg San Francisco General Hospital

Recruiting

San Francisco, California, United States, 94110

Contacts

Eliza Banbury

415.707.5399prism.trial@ucsf.edu

Principal Investigator:

Nicky J Mehtani, MD

More Information

Sponsor

Nicky Mehtani, MD, MPH

Last update posted

Nov 9, 2026

Last verified

Nov, 2026

Keywords

  • methamphetamine use disorder
  • HIV
  • methamphetamine
  • psilocybin
  • amphetamine-related disorders
  • stimulant use disorder
  • people with HIV
  • psychedelics
  • psychedelic-assisted therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-10. This information was provided to ClinicalTrials.gov by Nicky Mehtani, MD, MPH on 2026-11-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.