Alcoholism, Alcohol Use Disorder
Conditions
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
Interventions
DRUGPsilocybin
Single dosing session followed by 5 MET weekly sessions starting 24hrs after dosing
Sponsors
Johns Hopkins University
University of Maryland
Canadian Institutes of Health Research (CIHR)
University of Calgary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heavy drinking | Change from baseline to 1-, 4-, and 12-weeks post-dosing | Percent heavy drinking days (TLFB) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| Abstinence | Change from baseline to 1-, 4-, and 12-weeks post-dosing | Days abstinent (TLFB) |
| Quality of life | Change from baseline to 1-, 4-, and 12-weeks post-dosing | The World Health Organization Quality of Life (WHOQOL) 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 |
| Resting state functional connectivity | Change from baseline to 1-week post-dosing | — |
| Anxiety | Change from baseline to 1-, 4-, and 12-weeks post-dosing | The General Anxiety Disorder 7 (GAD-7) scale |
Countries
Canada
Contacts
Primary ContactKaitlin O'Grady
Outcome results
None listed