Behavior Brain Responses

Study Overview
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Brief Summary
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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.

Official Title
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Behavior and Brain Responses to Drugs

Conditions
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Alcohol Drinking, Drinking Behavior, Physiological Effects of Drugs, Central Nervous System Depression

Intervention / Treatment
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* Drug: Ethanol
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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21-35 years old 4-30 alcoholic drinks per week (as reported on PHQ or TLFB) No 'flushing' reaction to alcohol BMI 19-26 High school education or greater, fluent in English No night shift work No current or past year Axis I psychiatric disorder including drug/alcohol dependence No current psychopharmacological treatment No lifetime ADHD or prescription for ADHD medication No abnormal EKG, cardiovascular illness, high blood pressure No medical condition or pharmacological treatment for which alcohol is contraindicated Not pregnant, lactating, or planning to become pregnant Smoke <6 cigarettes per day

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ethanol<br>Subjects will receive ethanol (0.4 or 0.8 g/kg) which will be administered in a gelatin vehicle. | Drug: Ethanol<br>* 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.<br>|
| Placebo Comparator: Placebo (gelatin vehicle)<br>Subjects will receive placebo of black cherry sugar-free jello. | Other: Placebo<br>* The placebo comparator will be individual servings of back cheery sugar-free jello.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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. | Time Frame: Day 1 (baseline), 3, 5, 7 |