Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder

• Status: Not yet recruiting
• Trial end date: 2024-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Portland VA Research Foundation, Inc
• Collaborator: Steven and Alexandra Cohen Foundation
• Treatments: Psilocybin

Criteria

Inclusion Criteria:

• 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