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To compare responses to acute oral doses of ethanol in healthy young adults who experience mainly stimulant subjective effects from the drug or mainly sedative effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ethanol | Experimental | Subjects will receive ethanol (0.4 or 0.8 g/kg) which will be administered in a gelatin vehicle. |
|
| Placebo (gelatin vehicle) | Placebo Comparator | Subjects will receive placebo of black cherry sugar-free jello. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ethanol | Drug | The 0.8 g/kg body weight dose of gelatin alcohol will be divided into an average of 10 servings of 0.08 g/kg each. The 0.8 g/kg dose is equivalent to 4 standard drinks, where a standard drink is defined as one 12 oz beer, one 5 oz glass of wine, or one 1.5 oz shot of 80 proof alcohol. The 0.4 g/kg body weight dose of gelatin alcohol will be divided into an average of 5 servings of 0.08 g/kg each. The 0.4 g/kg dose is equivalent to 2 standard drinks, where a standard drink is defined as one 12 oz beer, one 5 oz glass of wine, or one 1.5 oz shot of 80 proof alcohol. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire Across Sessions | Participants will complete The Drug Effects Questionnaire during the initial baseline session to determine their subjective alcohol profile. The Drug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states : "Feel Drug", "Feel High", "Like Drug", and "Want More". All sub-scales ("Feel Drug", "Feel High", "Like Drug", and "Want More") are scored on a visual analogue scale (scroll bar on computer screen) ranging from 0-100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome. | At expected peak drug effect (30 min post drink administration) |
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| Name | Affiliation | Role |
|---|---|---|
| Harriet de Wit | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo First (0 g/kg), Then Ethanol (0.4 g/kg), Then Ethanol (0.8 g/kg) | Participants who received placebo first, then low dose ethanol then high dose ethanol |
| FG001 | Placebo (0 g/kg), Then Ethanol (0.8 g/kg), Then Ethanol (0.4 g/kg) | participants who received placebo, then high dose ethanol then low dose ethanol |
| FG002 | Ethanol (0.4 g/kg), Then Ethanol (0.8 g/kg), Then Placebo (0 g/kg) | participants who received low dose ethanol, then high dose ethanol, then placebo |
| FG003 | Ethanol First (0.8 g/kg) Then Ethanol (0.4 g/kg), Then Placebo (0 g/kg) | Participants who received high dose ethanol first, then low dose ethanol, then placebo |
| FG004 | Ethanol First (0.8 g/kg), Then Placebo (0 g/kg), Then Ethanol (0.4 g/kg), | Participants who received high dose ethanol first, then placebo, then low dose ethanol |
| FG005 | Ethanol First (0.4 g/kg), Then Placebo (0 g/kg), Then Ethanol (0.8 g/kg), | Participants who received low dose ethanol first, then placebo, then high dose ethanol |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sedative-like Effects (All Study) | Subjects that experienced more sedative like effects |
| BG001 | Stimulant-like (All Study) | Subjects that experienced more stimulant-like effects |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire Across Sessions | Participants will complete The Drug Effects Questionnaire during the initial baseline session to determine their subjective alcohol profile. The Drug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states : "Feel Drug", "Feel High", "Like Drug", and "Want More". All sub-scales ("Feel Drug", "Feel High", "Like Drug", and "Want More") are scored on a visual analogue scale (scroll bar on computer screen) ranging from 0-100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome. | Posted | Mean | Standard Deviation | units on a scale | At expected peak drug effect (30 min post drink administration) |
|
Through study completion, an average of 5 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ethanol (0.4 g/kg) | Subjects will receive ethanol (0.4 g/kg) which will be administered in a gelatin vehicle. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Harriet de Wit | University of Chicago | 7737023560 | dewitlab@yoda.bsd.uchicago.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 11, 2022 | Apr 11, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| D004327 | Drinking Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
| Placebo | Other | The placebo comparator will be individual servings of back cheery sugar-free jello. |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Education - High School Education | Count of Participants | Participants |
|
| OG001 | Ethanol (0.4 g/kg) | Low dose ethanol |
| OG002 | Ethanol (0.8 g/kg) | High dose ethanol |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Placebo (Gelatin Vehicle) | Subjects will receive placebo of black cherry sugar-free jello. Placebo: The placebo comparator will be individual servings of back cheery sugar-free jello. | 0 | 30 | 0 | 30 | 0 | 30 |
| EG002 | Ethanol (0.8 g/kg) | Subjects will receive ethanol (0.8 g/kg) which will be administered in a gelatin vehicle. | 0 | 30 | 0 | 30 | 0 | 30 |
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