Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder

Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder

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.

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.

Inclusion Criteria:

• United States military Veteran
• 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