NCT04982796

Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Portland VA Research Foundation, Inc · Academic / Other
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

• Amphetamine-Related Disorders

Interventions

Type	Name	Description
DRUG	Psilocybin	See description of psilocybin-enhanced psychotherapy arm.
BEHAVIORAL	Treatment-as-usual	See description of treatment-as-usual arm.

Timeline

• Start date: 2022-07-07
• Primary completion: 2025-12-31
• Completion: 2026-04-30
• First posted: 2021-07-29
• Last updated: 2025-12-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study