Phase 2
N=154
Acute and Residual Effects of Caffeinated Beer
Neurobehavioral Manifestations · Drug Related Sleep Disturbance · Alcohol Intoxication
Bottom Line
View on ClinicalTrials.gov: NCT00515294 ↗Enrolled (actual)
154
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Lane Position Deviation — -1.25; -1.36; -1.22; -1.21 feet
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Caffeinated Alcoholic Beer (Drug); Non-Caffeinated Alcoholic Beer (Other); Caffeinated Non-Alcoholic Beer (Drug); Non-Caffeinated, Non-Alcoholic Beer (Other)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Boston University
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lane Position Deviation |
-1.25; -1.36; -1.22; -1.21 | — |
| SECONDARY Psycho-motor Vigilance Test (PVT) |
278.7; 293.3; 233.1; 241.8 | — |
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.
Eligibility Criteria
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 zones in the last month will be rescheduled for later participation (minimum of 1 month from time-zone travel)
- On average consume greater than 4 cups of coffee per day (>400 mg/day)
- Participants who report ever getting motion sick during screening or become motion sick after practicing on the driving simulator during Session 1.
- Weigh more than 230 Lbs.
Data sourced from ClinicalTrials.gov (NCT00515294). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.