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Active, not recruitingPhase 1 / Phase 2

Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder

NCT04982796 · Portland VA Research Foundation, Inc

Closed to entry
Status
Not accepting participants
Phase 1 / Phase 2
Phase
30
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

This is a proof-of-concept randomized clinical trial of psilocybin-enhanced psychotherapy versus treatment-as-usual among individuals being treated for methamphetamine use disorder.

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

  • Acceptability

    Measured over End of 6-week intervention; approximately 42 days

  • Proportion of patients who complete the intervention and follow-up

    Measured over End of 6-week intervention to 180 days post-discharge follow-up; approximately 180 days

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

25 Years to 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * United States military Veteran * Moderate to severe methamphetamine use disorder using the DSM-V diagnostic criteria * Desire to cease or reduce methamphetamine use Exclusion Criteria: * Have uncontrolled hypertension or clinically significant cardiovascular disease * History of seizure disorder in adulthood * CNS metastases or symptomatic central nervous system (CNS) infection * Poorly controlled diabetes mellitus * Taking certain medications that may interact with psilocybin * History of any primary persistent psychotic disorder, including schizophrenia, schizoaffective disorder, bipolar disorder with psychosis, major depressive disorder with psychosis, or schizophreniform disorder * History of bipolar I disorder * Current eating disorder with active purging * History of hallucinogen use disorder * Pregnant or breast feeding

Where

1 study site

FacilityCityRegionCountry
Portland VA Health Care SystemVancouverWashingtonUnited 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.

NCT04982796 on ClinicalTrials.gov →

Last updated in the registry 2026-04-22. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits