Psilocybin-Assisted Psychotherapy for Alcohol Use Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age22-65
SponsorUniversity of Calgary
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Psilocybin
DrugSingle dosing session followed by 5 MET weekly sessions starting 24hrs after dosing
Treatment groups
128 Participants
are divided into 2 treatment groupsGroup A: High Dose (25mg)Experimental treatment 1 intervention
Group B: Low dose (1mg)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Heavy drinking
Percent heavy drinking days (TLFB)
Time frame
Change from baseline to 1-, 4-, and 12-weeks post-dosingSecondary outcomes
1
Abstinence
Days abstinent (TLFB)
Time frame
Change from baseline to 1-, 4-, and 12-weeks post-dosing2
Biomarkers of alcohol consumption
Phosphatidylethanol (Peth)
Time frame
Change from baseline to 1-, 4-, and 12-weeks post-dosing3
Alcohol cue reactivity
Alcohol urge questionnaire (AUQ)
Time frame
Change from baseline to 1-, 4-, and 12-weeks post-dosing4
Cognitive flexibility
Berg Card Sorting Task
Time frame
Change from baseline to 1-, 4-, and 12-weeks post-dosingSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Calgary
Lead sponsor
Johns Hopkins University
Collaborator
University of Maryland
Collaborator
Canadian Institutes of Health Research (CIHR)
Collaborator
Source ClinicalTrials.gov