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

University of Calgary

Status and phase: Enrolling; Phase 2

Conditions: Alcoholism; Alcohol Use Disorder

Treatments: Drug: Psilocybin

Study type: Interventional

Funder types: Other

Identifiers

NCT05995769

REB23-0666

Details and patient eligibility

About

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).

Full description

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

Enrollment: 128 estimated patients

Sex: All

Ages: 22 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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128 participants in 2 patient groups

High Dose (25mg)

Experimental group

Description:

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

Treatment:

Drug: Psilocybin

Low dose (1mg)

Active Comparator group

Description:

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

Treatment:

Drug: Psilocybin