Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder

NCT ID: NCT04982796

Last Updated: 2025-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-07

Study Completion Date

2026-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The trial will take place with individuals admitted to a residential rehabilitation treatment program. The treatment protocol will consist of 4 preparatory therapy visits, 2 psilocybin sessions (25-30mg), and 8 total integration therapy visits. Primary aims assess acceptability, feasibility, and safety with a primary endpoint at the conclusion of the study intervention. An additional aim assesses preliminary efficacy for methamphetamine use disorder and overall functioning at follow-up assessments 60 and 180 days after discharge from the residential treatment program.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Amphetamine-Related Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Clinical interviewers will be blinded to condition and study timepoint.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment-as-Usual

Treatment-as-usual while admitted to a residential rehabilitation treatment program.

Group Type OTHER

Treatment-as-usual

Intervention Type BEHAVIORAL

See description of treatment-as-usual arm.

Psilocybin-enhanced psychotherapy

Psilocybin will be administered twice (25mg \& 30mg two weeks apart) in addition to a 6-week psychotherapy protocol while admitted to a residential rehabilitation treatment program.

Group Type EXPERIMENTAL

Psilocybin

Intervention Type DRUG

See description of psilocybin-enhanced psychotherapy arm.

Treatment-as-usual

Intervention Type BEHAVIORAL

See description of treatment-as-usual arm.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Psilocybin

See description of psilocybin-enhanced psychotherapy arm.

Intervention Type DRUG

Treatment-as-usual

See description of treatment-as-usual arm.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Steven & Alexandra Cohen Foundation

OTHER

Sponsor Role collaborator

Portland VA Research Foundation, Inc

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Chris Stauffer, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Portland VA Health Care System

Vancouver, Washington, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Zoe Gupta, BA

Role: CONTACT

(360) 216-3489

Bianca Watt, MSc

Role: CONTACT

(503) 781-1205

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Bianca Watt, MSc

Role: primary

(503) 781-1205

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Frontline Clinician Psilocybin Study
NCT05163496 COMPLETED PHASE3
Psilocybin and Spiritual Practice
NCT00802282 COMPLETED PHASE1