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COMPLETED Phase 1

Acute and Residual Effects of Caffeinated Beer

NCT00515294 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 154 participants
Start Date 2006-10
Est. Completion 2009-10
Phase Phase 1

Sponsor

Boston University

150 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00515294

The ClinicalTrials.gov registry entry for NCT00515294 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 154 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston University, which has 150 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00515294 reports 1 study location spanning 1 distinct geographic area — top geographies include Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00515294?

This trial is sponsored by Boston University, which has 150 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial