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Can a psychedelic help break meth addiction in people with HIV?

NCT ID NCT07756736

Disease control Sponsor: Nicky Mehtani, MD, MPH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This trial explores whether a single dose of psilocybin, combined with motivational support therapy, can help people with HIV who have moderate-to-severe methamphetamine use disorder reduce or stop their meth use. Participants will be randomly assigned to receive either a higher (25 mg) or lower (5 mg) dose of psilocybin during a monitored session, with therapy visits before and after. The study focuses on whether this approach is feasible, acceptable, and safe, and tracks methamphetamine use for up to three months afterward.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
psilocybin (a psychedelic compound) combined with motivational support therapy
What this could lead to
If successful, this could point toward a new treatment approach for methamphetamine use disorder in people with HIV, potentially improving their health and quality of life.
What could go wrong
This is a small early-phase trial, so results may not apply broadly. Psilocybin can cause intense psychological effects, and its safety in this population is still being tested.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

25 to 64 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

AIDS amphetamine abuse HIV infectious disease methamphetamine dependence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Human immunodeficiency virus (HIV) Methamphetamine use disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • UCSF at Zuckerberg San Francisco General Hospital

    San Francisco, California, 94110, United States

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Other studies related to the condition(s) this trial covers.