Clinical trial NCT05995769: Psilocybin-Assisted Psychotherapy for Alcohol Use Disorder
Official title: Mechanisms Supporting Psilocybin-assisted Psychotherapy for Alcohol Use Disorder: A Randomized, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Alcohol Use Disorder
Alcoholism
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: University of Maryland
name: Canadian Institutes of Health Research (CIHR)
First posted: 2023-08-16
Enrollment: 128
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Heavy drinking
timeFrame: Change from baseline to 1-, 4-, and 12-weeks post-dosing
Secondary outcomes:
measure: Abstinence
timeFrame: Change from baseline to 1-, 4-, and 12-weeks post-dosing
measure: Biomarkers of alcohol consumption
timeFrame: Change from baseline to 1-, 4-, and 12-weeks post-dosing
measure: Alcohol cue reactivity
timeFrame: Change from baseline to 1-, 4-, and 12-weeks post-dosing
measure: Cognitive flexibility
timeFrame: Change from baseline to 1-, 4-, and 12-weeks post-dosing
measure: Depression
timeFrame: Change from baseline to 1-, 4-, and 12-weeks post-dosing
measure: Anxiety
timeFrame: Change from baseline to 1-, 4-, and 12-weeks post-dosing
measure: Quality of life
timeFrame: Change from baseline to 1-, 4-, and 12-weeks post-dosing
measure: Glutamate levels
timeFrame: Change from baseline to 1-week post-dosing
measure: GABA levels
timeFrame: Change from baseline to 1-week post-dosing
measure: Resting state functional connectivity
timeFrame: Change from baseline to 1-week post-dosing
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Leah Mayo, PhD
role: PRINCIPAL_INVESTIGATOR
References: