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Not yet recruitingPhase 2

Psilocybin for Methamphetamine Use Disorder

NCT07774702 · Peter Hendricks

Closed to entry
Status
Not accepting participants
Phase 2
Phase
42
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

This trial tests whether psilocybin-assisted treatment can help adults stop using methamphetamine. Participants receive a single oral dose of psilocybin during a supervised session, paired with brief cognitive behavioral therapy, and are followed for up to six months. The study is supported by the HEAL Initiative (https://www.nih.gov/heal).

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Abstinent Days

    Measured over Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3).

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Age 18+ * DSM-5 moderate or severe Methamphetamine Use Disorder * Severity of Dependence Scale score ≥ 4 * Methamphetamine use on more than 7 of the past 30 days and more than one positive urine test before randomization * A goal of complete abstinence on the Thoughts About Abstinence questionnaire * Able to read, write, and speak English * A friend or family member available for post-session release * Good general health by history and physical * Confirmed pre-dose abstinence of at least 24 hours (clinically assessed) Exclusion Criteria: * Pregnancy or breastfeeding, or not using effective contraception * Current psychiatric diagnoses other than a mild substance use disorder or tobacco/nicotine use disorder * Current hypertension (\>140/90 at rest) * Regular use of centrally acting serotonergic medications or MAO inhibitors (washout/re-screen permitted) * Personal history of any psychotic or bipolar I/II disorder, or a first- or second-degree relative with such * Current suicidal or homicidal ideation * Plan to relocate within 6 months * Psychedelic use in the past 3 years, more than 3 lifetime psychedelic occasions, more than 3 lifetime ketamine or MDMA occasions, or any prior 5-MeO-DMT or ibogaine use

Where

1 study site

FacilityCityRegionCountry
University of Alabama at BirminghamBirminghamAlabamaUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT07774702 on ClinicalTrials.gov →

Last updated in the registry 2026-08-19. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Recruiting in