CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 154 enrolled
Drug / intervention
Caffeinated Alcoholic Beer +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00515294
NCT00515294Phase 2Completed
CompareCT.gov

Acute and Residual Effects of Beer VS. Caffeinated Beer On Simulated Driving

Boston University·interventional·Posted Aug 13, 2007·Updated Jun 28, 2017

In Brief

A Phase 2 clinical trial evaluating Caffeinated Alcoholic Beer, Non-Caffeinated Alcoholic Beer, and 2 other interventions for Neurobehavioral Manifestations and 2 related conditions. Completed, enrolled 154 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeurobehavioral Manifestations, Drug Related Sleep Disturbance, Alcohol Intoxication
CountriesUnited States
CollaboratorsBrown University, University of Michigan, Centers for Disease Control and Prevention

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 13, 2007
Enrollment StartOct 1, 2006
Primary CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 18.9 years ago

Interventions

Caffeinated Alcoholic Beerdrug

Alcoholic Beer plus Caffeine Citrate powder.

Non-Caffeinated Alcoholic Beerother

Alcoholic Non-Caffeinated Beer

Caffeinated Non-Alcoholic Beerdrug

Non-Alcoholic Beer plus Caffeine Citrate powder.

Non-Caffeinated, Non-Alcoholic Beerother

Non-Alcoholic Beer