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| Name | Class |
|---|---|
| Optimapharm | INDUSTRY |
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The goal of this clinical trial is to investigate treatment with psilocybin and psychotherapy for the treatment of people with Alcohol Use Disorder (AUD). The main question[s] it aims to answer are:
Participants will
Researchers will compare psilocybin and placebo groups to see if alcohol consumption is decreased.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psilocybin | Experimental | 2 oral doses of 25mg psilocybin capsules |
|
| Placebo | Placebo Comparator | 2 oral doses of placebo (microcrystalline cellulose) capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psilocybin | Drug | Psilocybin and psychotherapy |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in the number of Heavy Drinking Days | Mean number of HDD from V5 (baseline) measured monthly (4 weeks) over the treatment period (Week 8), where heavy drinking is defined as the consumption of ≥60 g alcohol/day (if male) or ≥40 g alcohol/day (if female). | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hannu Alho, MD | Addiktum Oy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sabi Mind | Calgary | Alberta | T3C 0J7 | Canada | ||
| Okanagan Clinical Trials |
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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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| Drug |
Placebo and psychotherapy |
|
| Kelowna |
| British Columbia |
| Canada |
| Centre for Neurology Studies | Surrey | British Columbia | Canada |
| University of British Columbia, Department of Psychiatry, BRAIN Lab | Vancouver | British Columbia | V6T 1Z3 | Canada |
| Centricity Research | Halifax | Nova Scotia | B3S 1N2 | Canada |
| MacAnxiety Research Centre | Hamilton | Ontario | L8S 1B7 | Canada |
| Department of Psychiatry, Queen's University | Kingston | Ontario | Canada |
| Centre for Addiction and Mental Health | Toronto | Ontario | M6J 1H4 | Canada |
| Research Center Oxidi Oy / Addiktum Oy | Helsinki | Finland |
| A-Klinikka | Kouvola | 45100 | Finland |
| Mentacare Oy | Oulu | Finland |
| Addiktum Oy | Turku | Finland |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D014363 | Tryptamines |
| D054836 | Indolizidines |
| D007212 | Indolizines |