Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder

NCT04982796 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Amphetamine-Related Disorders

Keywords

methamphetamine, stimulant, psilocybin, psychedelic, psychotherapy

Outcome Measures

Primary Outcomes (2)

• Acceptability

  We will use a 7-point Likert scale to measure each participant's perceived benefit and perceived harm of the intervention.

  End of 6-week intervention; approximately 42 days

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

  We will observe the proportion of patients who complete the intervention and follow-up to determine feasibility.

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

Secondary Outcomes (8)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  180 day post-discharge follow-up; approximately 222 days post-enrollment

• Methamphetamine Use, self-report

  60 days post-discharge follow-up; approximately 102 days post-enrollment

• Methamphetamine Use, self-report

  180 days post-discharge follow-up; approximately 222 days post-enrollment

• Methamphetamine Use, urine

  60 days post-discharge follow-up; approximately 102 days post-enrollment

• Methamphetamine Use, urine

  180 days post-discharge follow-up; approximately 222 days post-enrollment

Other Outcomes (17)

• Change from baseline in Stimulant Craving at end-of-intervention

  approximately 42 days post-enrollment

• Change from baseline in Stimulant Craving at 60 day post-discharge follow-up

  approximately 102 days post-enrollment

• Change from baseline in Stimulant Craving at 180 day post-discharge follow-up

  approximately 222 days post-enrollment

Study Arms (2)

Psilocybin-enhanced psychotherapy

EXPERIMENTAL

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.

Drug: Psilocybin; Behavioral: Treatment-as-usual

Treatment-as-Usual

OTHER

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

Behavioral: Treatment-as-usual

Interventions

Psilocybin DRUG

See description of psilocybin-enhanced psychotherapy arm.

Psilocybin-enhanced psychotherapy

Treatment-as-usual BEHAVIORAL

See description of treatment-as-usual arm.

Psilocybin-enhanced psychotherapy; Treatment-as-Usual

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• United States military Veteran
• Moderate to severe methamphetamine use disorder using the DSM-V diagnostic criteria
• Desire to cease or reduce methamphetamine use

You may not qualify if:

• 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

Sponsors & Collaborators

• Portland VA Research Foundation, Inc: lead
• Steven & Alexandra Cohen Foundation: collaborator

Study Sites (1)

Portland VA Health Care System

Vancouver, Washington, 98661, United States

Location

MeSH Terms

Conditions

Amphetamine-Related Disorders

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Officials

• Chris Stauffer, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Clinical interviewers will be blinded to condition and study timepoint.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: July 29, 2021
• Study Start: July 7, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)