Overview

This trial is active, not recruiting.

Condition alcoholism
Treatments ethanol, placebo, diphenhydramine, caffeine
Sponsor University of Chicago
Collaborator National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Start date March 2004
End date July 2017
Trial size 400 participants
Trial identifier NCT00961792, 12119a, 5R01AA013746

Summary

This study attempts to elucidate the factors that contribute to escalation and maintenance of excessive ethanol drinking in young adults by:

1. Examining subjective and objective response differences to alcohol and other common substances in a sample of young, adult social drinkers with varying consumption patterns.

2. Determining whether response to alcohol and other substances is predictive of future consumption patterns through longitudinal follow-up interviews.

3. Examining the relationship between responses to alcohol and other substances at baseline and re-examination testing to evaluate if consumption patterns moderate this relationship.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose screening
Arm
(Experimental)
Beverage containing 0.8 g/kg alcohol
ethanol Kool-Aid
Beverage containing 0.8 g/kg ethanol, 0.4 g/kg ethanol
(Experimental)
Beverage containing 0.4 g/kg alcohol
ethanol Kool-Aid
Beverage containing 0.8 g/kg ethanol, 0.4 g/kg ethanol
(Placebo Comparator)
Beverage containing 0.0 g/kg alcohol to act as placebo
placebo
Beverage containing 0.0 g/kg alcohol to act as placebo
(Experimental)
Beverage containing 1.5 standard dose of Diphenhydramine (Benadryl)
diphenhydramine Benadryl
Beverage containing dose equivalent to 1.5 standard doses of Diphenhydramine (Benadryl)
(Experimental)
Beverage containing the equivalent of 1.5 times participant's average caffeine consumption
caffeine
Beverage containing the equivalent of 1.5 times the participant's daily caffeine intake

Primary Outcomes

Measure
Subjective response to alcohol and other common substances utilizing mood questionnaires in social drinking young adults
time frame: Measured during 5 timepoints at each experimental session: 1) Pre-drink baseline, 2) +30 minutes, 3) +60 minutes, 4) +120 minutes, and 5) +180 minutes following the initiation of beverage consumption

Secondary Outcomes

Measure
Substance Use Behavior Reported During Follow-Up Interviews
time frame: Measured at 3, 6, 9, 12, 15, 18, 21, 24, 36, 48, and 60 months following the final experimental session

Eligibility Criteria

Male or female participants from 21 years up to 29 years old.

Inclusion Criteria: - Age 21-29 - Weigh between 110-210 lbs - Drink alcohol at least once weekly with weekly "binge" drinking episodes - Available to complete in-person screening and 2, 4 hour experimental sessions at the University of Chicago - Available by phone, mail, or Internet for follow-up interviews for at least 2 years following sessions Exclusion Criteria: - Current or past major medical or psychiatric disorders including alcohol and substance dependence

Additional Information

Official title Individual Differences After Consumption of Alcohol and Other Common Substances and Long-Term Follow-Up of Social Drinking, Young Adults
Principal investigator Andrea C King, PhD
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by University of Chicago.