RecruitingPhase 1Phase 2NCT04982796

Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder


Sponsor

Portland VA Research Foundation, Inc

Enrollment

30 participants

Start Date

Jul 7, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 25 YearsMax Age: 65 Years

Inclusion Criteria3

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

Exclusion Criteria10

  • 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

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Interventions

DRUGPsilocybin

See description of psilocybin-enhanced psychotherapy arm.

BEHAVIORALTreatment-as-usual

See description of treatment-as-usual arm.


Locations(1)

Portland VA Health Care System

Vancouver, Washington, United States

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NCT04982796