Psilocybin-Assisted Psychotherapy for Alcohol Use Disorder (PAP-AUD)

Mechanisms Supporting Psilocybin-assisted Psychotherapy for Alcohol Use Disorder: A Randomized, Controlled Clinical Trial

Johns Hopkins University, University of Maryland, Canadian Institutes of Health Research (CIHR), Bloom Psychedelic Therapy and Research Institute

The aim of this study is to determine if a single dose of psilocybin administered with motivational enhancement therapy (MET) can reduce heavy drinking in patients with an alcohol use disorder (AUD).

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

PEX010 (Oral Psilocybin), 25mg; single dose administered 24hrs prior to first of 5 weekly MET sessions

PEX010 (Oral Psilocybin), 1mg; single dose administered 24hrs prior to first of 5 weekly MET sessions

Inclusion Criteria: Meets DSM-5 AUD criteria of at least moderate severity At least 5 heavy drinking days in past 30 days At least 18 (females) or 24 (males) drinks per week in past 30 days Desire to decrease alcohol consumption Limited lifetime hallucinogen use (less than 10 times total, none in past 6 months) 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