Psilocybin-Assisted Psychotherapy for Alcohol Use Disorder

Alcohol Use Disorder Clinical Trial

— PAP-AUD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05995769
• Other study ID #: REB23-0666
• Status: Recruiting
• Phase: Phase 2
• Start date: March 20, 2024
• Est. completion date: October 1, 2027

Study information

• Verified date: August 2023
• Source: University of Calgary
• Contact: Kaitlin O'Grady
• Phone: 587-893-0257
• Email: pactlab[@]ucalgary.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: October 1, 2027
• Est. primary completion date: October 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

Drug:
• Psilocybin
Single dosing session followed by 5 MET weekly sessions starting 24hrs after dosing

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta

Sponsors (4)

Lead Sponsor	Collaborator
University of Calgary	Canadian Institutes of Health Research (CIHR), Johns Hopkins University, University of Maryland

Country where clinical trial is conducted

Canada, 

Outcome

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