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NCT00515294 · ClinicalTrials.gov registry record · Phase 1
Acute and Residual Effects of Caffeinated Beer
A Phase 1 study of Alcohol Intoxication and Neurobehavioral Manifestations, sponsored by Boston University.
- Completed
- Registry status
- Phase 1
- Development phase
- 154
- Enrollment target
- 1
- Study location
NCT00515294: Completed Phase 1 study of Alcohol Intoxication and Neurobehavioral Manifestations, sponsored by Boston University.
NCT00515294 is a Phase 1 study of Alcohol Intoxication and Neurobehavioral Manifestations that has completed, run by Boston University. The registered enrollment target is 154 participants, below the 337-participant average among 15 other Alcohol Intoxication trials with a reported enrollment target (54% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00515294, a Phase 1 study of Alcohol Intoxication and Neurobehavioral Manifestations, has completed, sponsored by Boston University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 154 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The reported lane position deviation indicates the position of the car relative to the center line in feet in the driver simulator. A deviation of 0 indicates no deviation from the center line (the car is positioned farthest from the road edge). Negative numbers indicate deviations to the right of the center line with the car positioned within the lane closer to the road edge. Positive numbers indicate deviations to the left of the center line with the car positioned in the lane of oncoming traf
Conditions Studied
Interventions
- DRUG Caffeinated Alcoholic Beer
- OTHER Non-Caffeinated Alcoholic Beer
- DRUG Caffeinated Non-Alcoholic Beer
- OTHER Non-Caffeinated, Non-Alcoholic Beer
Study Locations (1)
Massachusetts
- General Clinical Research Center, Boston Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 154 participants |
| Start Date | 2006-10 |
| Est. Completion | 2009-10 |
| Phase | Phase 1 |
What the finished NCT00515294 record still lists
NCT00515294 is an interventional study that assigns participants to a tested intervention. The registered 154 participants enrollment target is mid-sized for trials with a published cap, below the 337-participant average among 15 other Alcohol Intoxication trials with a reported enrollment target (54% lower).
The record links to 3 conditions, with Alcohol Intoxication appearing as the primary indexed condition, and to 4 interventions - of which Caffeinated Alcoholic Beer is the first listed.
NCT00515294 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00515294 about?
NCT00515294 is a clinical study titled "Acute and Residual Effects of Caffeinated Beer". 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...
What is the current status of trial NCT00515294?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 154 participants. The study started on 2006-10. Estimated completion is 2009-10.
What conditions does trial NCT00515294 study?
This clinical trial studies the following conditions: Alcohol Intoxication, Neurobehavioral Manifestations, Drug Related Sleep Disturbance.
What interventions are being tested in trial NCT00515294?
The interventions under investigation include: Caffeinated Alcoholic Beer (DRUG), Non-Caffeinated Alcoholic Beer (OTHER), Caffeinated Non-Alcoholic Beer (DRUG), Non-Caffeinated, Non-Alcoholic Beer (OTHER).
Who is sponsoring clinical trial NCT00515294?
This trial is sponsored by Boston University, which has 185 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00515294 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00515294's enrollment target sits among peer trials
154 11th of 15 higher than 5 of 15 other Alcohol Intoxication trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alcohol Intoxication trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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