Psilocybin-Assisted Psychotherapy for Alcohol Use Disorder

Phase 2

Recruiting

• Conditions: Alcoholism; Alcohol Use Disorder
• Interventions: Drug: Psilocybin

• Registration Number: NCT05995769
• Lead Sponsor: University of Calgary

Brief Summary

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).

Detailed 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

Study Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-09
• Study First Submitted QC: 2023-08-09
• Study First Posted: 2023-08-16
• Study Start: 2024-03-20
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-07
• Primary Completion: 2027-10-01
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Dose (25mg)	Psilocybin	PEX010 (Oral Psilocybin), 25mg; single dose administered 24hrs prior to first of 5 weekly MET sessions
Low dose (1mg)	Psilocybin	PEX010 (Oral Psilocybin), 1mg; single dose administered 24hrs prior to first of 5 weekly MET sessions

Primary Outcome Measures

Name	Time	Method
Heavy drinking	Change from baseline to 1-, 4-, and 12-weeks post-dosing	Percent heavy drinking days (TLFB)

Secondary Outcome Measures

Name	Time	Method
Cognitive flexibility	Change from baseline to 1-, 4-, and 12-weeks post-dosing	Berg Card Sorting Task
Depression	Change from baseline to 1-, 4-, and 12-weeks post-dosing	The Montgomery-Åsberg Depression Rating Scale (MADRS)
Resting state functional connectivity	Change from baseline to 1-week post-dosing
Abstinence	Change from baseline to 1-, 4-, and 12-weeks post-dosing	Days abstinent (TLFB)
Biomarkers of alcohol consumption	Change from baseline to 1-, 4-, and 12-weeks post-dosing	Phosphatidylethanol (Peth)
Alcohol cue reactivity	Change from baseline to 1-, 4-, and 12-weeks post-dosing	Alcohol urge questionnaire (AUQ)
Quality of life	Change from baseline to 1-, 4-, and 12-weeks post-dosing	The World Health Organization Quality of Life (WHOQOL) scale
Anxiety	Change from baseline to 1-, 4-, and 12-weeks post-dosing	The General Anxiety Disorder 7 (GAD-7) scale
Glutamate levels	Change from baseline to 1-week post-dosing	MR spectroscopy of glutamate levels in the anterior cingulate cortex
GABA levels	Change from baseline to 1-week post-dosing	MR spectroscopy of GABA levels in the anterior cingulate cortex

Trial Locations

Locations (1)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada