deltatrials
Active Not Recruiting INTERVENTIONAL NCT04982796

Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder

Sponsor: Portland VA Research Foundation, Inc

Updated 9 times since 2021 Last updated: Apr 20, 2026 Started: Jul 7, 2022 Primary completion: Dec 31, 2026 Completion: Dec 31, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This observational or N/A phase trial investigates Amphetamine-Related Disorders and is currently ongoing. Portland VA Research Foundation, Inc leads this study, which shows 9 recorded versions since 2022 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Study Description(click to expand)

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.

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.

Status Flow

~Sep 2021 – ~Dec 2021 · 3 months · monthly snapshot~Dec 2021 – ~Sep 2022 · 9 months · monthly snapshotNot Yet Recruiting~Sep 2022 – ~Jun 2023 · 9 months · monthly snapshotRecruiting~Jun 2023 – ~Jul 2024 · 13 months · monthly snapshotRecruiting~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Aug 2025 · 11 months · monthly snapshotRecruiting~Aug 2025 – ~Jan 2026 · 5 months · monthly snapshotRecruiting~Jan 2026 – ~Apr 2026 · 4 months · monthly snapshotApr 23, 2026 – present · 54 days · daily API

Change History

9 versions recorded
  1. Apr 23, 2026 — Present [daily]

    Active Not Recruiting

    Status: RecruitingActive Not Recruiting · Phase: PHASE1/PHASE2None

  2. Jan 2026 — Apr 2026 [monthly]

    Recruiting PHASE1/PHASE2

  3. Aug 2025 — Jan 2026 [monthly]

    Recruiting PHASE1/PHASE2

  4. Sep 2024 — Aug 2025 [monthly]

    Recruiting PHASE1/PHASE2

  5. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE1/PHASE2

    Phase: PHASE1_PHASE2PHASE1/PHASE2

Show 4 earlier versions
  1. Jun 2023 — Jul 2024 [monthly]

    Recruiting PHASE1_PHASE2

  2. Sep 2022 — Jun 2023 [monthly]

    Recruiting PHASE1_PHASE2

    Status: Not Yet RecruitingRecruiting

  3. Dec 2021 — Sep 2022 [monthly]

    Not Yet Recruiting PHASE1_PHASE2

  4. Sep 2021 — Dec 2021 [monthly]

    Not Yet Recruiting PHASE1_PHASE2

    First recorded

Eligibility 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.

Contact Information

Sponsor contact:
  • Portland VA Research Foundation, Inc
  • Steven & Alexandra Cohen Foundation
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations