Behavior Brain Responses (BBR)
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|ClinicalTrials.gov Identifier: NCT03964350|
Recruitment Status : Recruiting
First Posted : May 28, 2019
Last Update Posted : June 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Drinking Drinking Behavior Physiological Effects of Drugs Central Nervous System Depression||Drug: Ethanol Other: Placebo||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Behavior and Brain Responses to Drugs|
|Actual Study Start Date :||May 28, 2019|
|Estimated Primary Completion Date :||July 1, 2020|
|Estimated Study Completion Date :||November 1, 2020|
Subjects will receive ethanol (0.4 or 0.8 g/kg) which will be administered in a gelatin vehicle.
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.
Placebo Comparator: Placebo (gelatin vehicle)
Subjects will receive placebo of black cherry sugar-free jello.
The placebo comparator will be individual servings of back cheery sugar-free jello.
- Change in Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire [ Time Frame: Time Frame: Day 1 (baseline), 3, 5, 7 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03964350
|Contact: Matthew Bonaemail@example.com|
|United States, Illinois|
|University of Chicago||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Matthew Bona 773-702-3560 firstname.lastname@example.org|
|Principal Investigator:||Harriet de Wit||University of Chicago|