Behavior Brain Responses

Alcohol Drinking Clinical Trial

— BBR  

Official title:

Behavior and Brain Responses to Drugs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03964350
• Other study ID #: IRB19-0293
• Status: Completed
• Phase: Early Phase 1
• Start date: May 28, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2021
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 35 Years

Eligibility

• 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

Related Conditions & MeSH terms

• Alcohol Drinking
• Central Nervous System Depression
• Drinking Behavior
• Physiological Effects of Drugs

Intervention

Drug:
• Ethanol
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.

Other:
• Placebo
The placebo comparator will be individual servings of back cheery sugar-free jello.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	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