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This study was intended to produce pilot data for a center grant component that will no longer be conducted.
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The purpose of this study is to determine whether cannabidiol, relative to placebo, affects subjective response to alcohol or alcohol drinking.
This study will examine the effects of Epidiolex among adults who drink alcohol heavily but who are not seeking treatment for their alcohol use. Epidiolex is an FDA-approved formulation of cannabidiol, the primary non-psychoactive constituent of cannabis. Participants in the study will be randomly assigned to take Epidiolex or placebo for 8 days. There are 3 study visits, including a day-long visit in the laboratory.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cannabidiol | Active Comparator | Cannabidiol 6 mL of 100 mg/mL cannabidiol oral solution per day for 8 days |
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| Placebo | Placebo Comparator | Placebo 6 mL oral solution per day for 8 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabidiol | Drug | Cannabidiol oral solution |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Average alcohol-induced sedation after medication ingestion | Biphasic Alcohol Effects Scale sedation subscale score (range = 0-70; higher scores = greater sedation) | Average of measurements obtained 30, 60, 90, and 120 minutes following alcohol administration in the lab. Alcohol will be administered 2.5 hours after ingestion of study medication. |
| Average subjective response to alcohol after medication ingestion | Subjective High Assessment Scale score (range = 0-130; higher scores = greater intoxication) | Average of measurements obtained 30, 60, 90, and 120 minutes following alcohol administration in the lab. Alcohol will be administered 2.5 hours after ingestion of study medication. |
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol drinking in natural environment | Total number of standard drinks per day consumed during natural (usual environment) conditions | 8 days of medication ingestion. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph P Schacht, PhD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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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 |
|---|---|
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Placebo oral solution |
|