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| Name | Class |
|---|---|
| Johns Hopkins University | OTHER |
| University of Maryland | OTHER |
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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).
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Dose (25mg) | Experimental | PEX010 (Oral Psilocybin), 25mg; single dose administered 24hrs prior to first of 5 weekly MET sessions |
|
| Low dose (1mg) | Active Comparator | PEX010 (Oral Psilocybin), 1mg; single dose administered 24hrs prior to first of 5 weekly MET sessions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psilocybin | Drug | Single dosing session followed by 5 MET weekly sessions starting 24hrs after dosing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Heavy drinking | Percent heavy drinking days (TLFB) | Change from baseline to 1-, 4-, and 12-weeks post-dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Abstinence | Days abstinent (TLFB) | Change from baseline to 1-, 4-, and 12-weeks post-dosing |
| Biomarkers of alcohol consumption | Phosphatidylethanol (Peth) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kaitlin O'Grady | Contact | 587-893-0257 | pactlab@ucalgary.ca |
| Name | Affiliation | Role |
|---|---|---|
| Leah Mayo, PhD | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Recruiting | Calgary | Alberta | T2N 4Z6 | Canada |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D011562 | Psilocybin |
| ID | Term |
|---|---|
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
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| Change from baseline to 1-, 4-, and 12-weeks post-dosing |
| Alcohol cue reactivity | Alcohol urge questionnaire (AUQ) | Change from baseline to 1-, 4-, and 12-weeks post-dosing |
| Cognitive flexibility | Berg Card Sorting Task | Change from baseline to 1-, 4-, and 12-weeks post-dosing |
| Depression | The Montgomery-Åsberg Depression Rating Scale (MADRS) | Change from baseline to 1-, 4-, and 12-weeks post-dosing |
| Anxiety | The General Anxiety Disorder 7 (GAD-7) scale | Change from baseline to 1-, 4-, and 12-weeks post-dosing |
| Quality of life | The World Health Organization Quality of Life (WHOQOL) scale | Change from baseline to 1-, 4-, and 12-weeks post-dosing |
| Glutamate levels | MR spectroscopy of glutamate levels in the anterior cingulate cortex | Change from baseline to 1-week post-dosing |
| GABA levels | MR spectroscopy of GABA levels in the anterior cingulate cortex | Change from baseline to 1-week post-dosing |
| Resting state functional connectivity | Change from baseline to 1-week post-dosing |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D014363 | Tryptamines |
| D054836 | Indolizidines |
| D007212 | Indolizines |