Psilocybin-Assisted Psychotherapy for Alcohol Use Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Psilocybin.
- Who it may be relevant to
- Registry conditions: Alcohol Use Disorder, Alcoholism. Basic parameters: 22 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Mechanisms Supporting Psilocybin-assisted Psychotherapy for Alcohol Use Disorder: A Randomized, Controlled Clinical Trial
Overview
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
Interventions
- Drug Psilocybin
Single dosing session followed by 5 MET weekly sessions starting 24hrs after dosing
Primary outcome measures
- Heavy drinking [Time frame: Change from baseline to 1-, 4-, and 12-weeks post-dosing]
Secondary outcome measures (10)
- Abstinence [Time frame: Change from baseline to 1-, 4-, and 12-weeks post-dosing]
- Biomarkers of alcohol consumption [Time frame: Change from baseline to 1-, 4-, and 12-weeks post-dosing]
- Alcohol cue reactivity [Time frame: Change from baseline to 1-, 4-, and 12-weeks post-dosing]
- Cognitive flexibility [Time frame: Change from baseline to 1-, 4-, and 12-weeks post-dosing]
- Depression [Time frame: Change from baseline to 1-, 4-, and 12-weeks post-dosing]
- Anxiety [Time frame: Change from baseline to 1-, 4-, and 12-weeks post-dosing]
- Quality of life [Time frame: Change from baseline to 1-, 4-, and 12-weeks post-dosing]
- Glutamate levels [Time frame: Change from baseline to 1-week post-dosing]
- GABA levels [Time frame: Change from baseline to 1-week post-dosing]
- Resting state functional connectivity [Time frame: Change from baseline to 1-week 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- University of Calgary — Calgary
Identifiers
NCT: NCT05995769 · REB23-0666