Psilocybin-Assisted Psychotherapy for Alcohol Use Disorder

The primary objective of this study is to determine if psilocybin administered with a standardized psychotherapeutic intervention, motivational enhancement therapy (MET), can reduce heavy drinking in a patient population with an alcohol use disorder (AUD). Patients with an AUD will be randomly allocated to either a high dose (25mg; active treatment) or a low dose (1mg; active control) psilocybin arm. All participants will receive 5 sessions of MET, starting at 24hrs post-dosing. Heavy drinking will be assessed as percent heavy drinking days using the Time Line Follow Back (TLFB) at baseline and 1-, 4-, and 12-weeks post-dosing.

A total of 128 male and female patients between the ages of 22-65 with a moderate to severe AUD diagnosis will be recruited from the community. Participants will undergo a thorough screening procedure and eligible participants will be randomly allocated to the high (N=64) or low (N=64) psilocybin doses. All participants will complete a baseline session consisting of clinical, behavioral, and neuroimaging measures. Following the single dosing session, participants will complete 5 weekly MET sessions. Neuroimaging measures will be assessed again at 1-week post-doing. Clinical and behavioral outcomes will be measured at 1-, 4-, and 12-weeks post-dosing

Inclusion criteria

• Meets DSM-5 AUD criteria of at least moderate severity
• Meets heavy drinking requirements (heavy drinking days, number of drinks) in past 30 days
• Desire to decrease alcohol consumption
• Limited lifetime hallucinogen use

Exclusion criteria

• Severe or moderate substance use disorder other than alcohol or nicotine in past 6 months
• Diagnosis of schizophrenia, bipolar disorders or first-degree relative with diagnosis
• Active suicidal ideation or serious attempt within past 3 years
• Currently pregnant, nursing, or trying to become pregnant
• Any notable abnormality on ECG, physical exam, or routine medical blood laboratory test