Acute and Residual Effects of Caffeinated Beer

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.

Conditions

• Neurobehavioral Manifestations
• Drug Related Sleep Disturbance
• Alcohol Intoxication

Interventions

OTHER

Non-Caffeinated, Non-Alcoholic Beer

Non-Alcoholic Beer

DRUG

Caffeinated Alcoholic Beer

Alcoholic Beer plus Caffeine Citrate powder.

OTHER

Non-Caffeinated Alcoholic Beer

Alcoholic Non-Caffeinated Beer

DRUG

Caffeinated Non-Alcoholic Beer

Non-Alcoholic Beer plus Caffeine Citrate powder.

Sponsors & Collaborators

• Brown University

  collaborator OTHER

• University of Michigan

  collaborator OTHER

• Centers for Disease Control and Prevention

  collaborator FED

• Boston University

  lead OTHER

Principal Investigators

• Jonathan Howland, PhD, MPH · Boston University

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Model

FACTORIAL

Eligibility

Min Age

21 Years

Max Age

30 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2006-10-31

Primary Completion

2009-10-31

Completion

2009-10-31

FDA Drug

Yes

Countries

• United States

Study Locations