CompletedPhase 1/2

Acute and Residual Effects of Caffeinated Beer

United States154 participantsStarted 2006-10

Plain-language summary

The aim of this study is to develop information about the acute and residual effects of a new product being targeted to young adults. Using a double placebo-controlled 2 X 2 factorial model study design, we will compare the acute and residual effects on driving impairment of caffeinated alcohol, non-caffeinated alcohol, caffeinated placebo, and non-caffeinated placebo. Under the alcohol conditions, participants will receive sufficient alcoholic beverage to attain a blood alcohol concentration (BAC) of .12 g%. Participants will be 144 undergraduate and graduate students, and recent college graduates.

Who can participate

Age range

21 Years – 30 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * College students, graduate students, or recent graduates * Between the ages of 21 and 30 years inclusive (as verified by valid drivers license) * Who, if a student, reports good academic standing * Have not been diagnosed with a sleep disorder * Are not daily smokers * At least occasionally in the past month, consume five drinks (for men) or more (four or more if female \[based on Flannery et al 2002\]) during a single drinking episode * Have a valid drivers license, so as to include only people who know how to drive. Exclusion Criteria: * Scores of 5 or more on a screening measure for alcoholism (the short version of the Michigan Alcohol Screening Test \[SMAST\]) * A history of counseling or treatment for chronic substance abuse by self-report * Daily smoker (to mitigate confounding of caffeine by nicotine withdrawal, or acute nicotine administration, smokers will be excluded from participation) * Current use of medications that affect the sleep/wake cycle or daytime alertness or that are contraindicated for alcohol * Presence of a health condition that contraindicates alcohol * Diagnosis of a sleep disorder (sleep apnea, narcolepsy, periodic limb movement, restless legs syndrome, circadian rhythm disorder, and insomnia) * Use of recreational drugs (e.g., marijuana) while participating in the study * Working overnight shifts * Female and pregnant, nursing, or not using reliable birth control * Participants who have traveled across two or more time zo…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Lane Position Deviation

Timeframe: 30 minutes post dosing

Trial details

NCT IDNCT00515294

SponsorBoston University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-10

Results submitted2017-03-06

View on ClinicalTrials.gov More Neurobehavioral Manifestations trials