Expired Study
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Boston, Massachusetts 02118


Purpose:

The primary goal of the study is to assess the residual effects of heavy drinking on academic performance. The investigators will also explore whether these effects differ by family history of alcohol abuse and hangover symptoms, as well as compare males and females with respect to these effects. The investigators' primary hypothesis is that intoxication (0.10g% blood alcohol concentration [BAC]) with an alcoholic beverage impairs next-day academic performance, as measured by scores on quizzes, standardized academic achievement tests, and standardized neurobehavioral assessments. Their secondary hypothesis is that family-history-positive individuals will show a greater performance decrement the day after heavy drinking than family-history-negative individuals.


Study summary:

The primary goal of the study is to assess the effect of heavy drinking on next day academic performance. We are using a placebo-controlled 2-period crossover design to compare the effects of dosing status on academic performance, with participants serving as their own controls. Participants are dosed on two separate occasions, once with non- alcoholic beverage and the other time with alcoholic beverage sufficient to raise blood alcohol to 0.10 g%. The morning after dosing, participants' academic performance is measured using a standardized achievement test (Graduate Record Exam) and a quiz on material presented in the video lecture the prior afternoon before dosing. Participants' cognition is also tested using the Neurobehavioral Evaluation System (NES3) and the Psychomotor Vigilance Test (PVT). We are collecting data on participants' demographics, family history of drinking problems and alcohol use. We are also collecting information on hangover symptoms and sleep quality the morning after dosing, in addition to participants' self ratings of academic performance. The procedure is conducted twice with one week in between, switching the individuals' dosing status, presenting a different, but comparable lecture and reading, and administering a different quiz based on the new lecture and reading and a different, but comparable standardized achievement exam. This design is intended to test the hypothesis that intoxication (0.10 g% BAC) with alcoholic beverage impairs next-day academic performance. Participation involves a total of five sessions over a two week period. Participants are undergraduates who volunteer and meet inclusion criteria. Prior to enrollment, volunteers are screened to ensure they meet initial eligibility criteria. Eligible volunteers receive written instructions regarding participation and are scheduled for the study sessions. Participants report to the study site on the first session for an additional screening by the study physician and go through the informed consent process. Eligible participants report back the next week for their first dosing night where they receive several drinks (alcohol or placebo) sufficient to raise their BAC to 0.10g%; the amount of beverage administered is based on their body weight. Those receiving placebo receive the same total quantity of beverage as those receiving alcohol. Both alcohol-dosed and placebo-dosed participants are breath-tested after they have completed their required dose. Participants sleep at the study site and are monitored overnight. The next morning they are awakened and are escorted to the exam room for the performance trial, which includes a quiz on the lecture and reading material, a GRE examination, the NES3 battery and the PVT. They return the next week for the second dosing night/dosing morning, and receive either alcohol or placebo, depending on what was administered the previous week, and take different but comparable performance tests.


Criteria:

Inclusion Criteria: - Ages 21-30 - Currently enrolled in college/university - Have had 5 or more drinks (4 if female) in the last 30 days - Score less than a 5 on the Short Michigan Alcohol Screening Test (SMAST) - No self-reported history of counseling or treatment for substance abuse - Not taking any medication contraindicated for alcohol use or that disrupts sleep - Doesn't have a health condition contraindicated for alcohol use - Has not been diagnosed with a primary sleep disorder - Has not been diagnosed with a mental health disorder - Not currently working night shifts at a job - Not routinely taking medications that affect sleep - If female, is using reliable birth control when necessary - Not a regular smoker - Likes the taste of beer Exclusion Criteria: - Less than age 21 and greater than age 30 - Not currently enrolled in college/university - Hasn’t had 5 or more drinks (4 if female) in the last 30 days (not a regular drinker) - Score greater than or equal to 5 on the Short Michigan Alcohol Screening Test (SMAST) - Self-reported history of counseling or treatment for substance abuse - Taking any medication contraindicated for alcohol use or that disrupts sleep - Has a health condition contraindicated for alcohol use - Has been diagnosed with a primary sleep disorder - Has been diagnosed with a mental health disorder - Currently working night shifts at a job - Routinely taking medications that affect sleep - Is a regular smoker - Is currently pregnant or nursing - If female, is not using reliable birth control when necessary - Not a regular drinker - Dislikes the taste of beer


NCT ID:

NCT00183170


Primary Contact:

Principal Investigator
David Rosenbloom, PhD
General Clinical Research Center, Boston University School of Public Health/Boston Medical Center

Barbara Cole
Phone: 617-638-4600
Email: barbcole@bu.edu


Backup Contact:

Email: jabloom@bu.edu
Jacey A Greece, MPH
Phone: 617-414-1894


Location Contact:

Boston, Massachusetts 02118
United States

Jacey A Greece, MPH
Phone: 617-414-1894
Email: jabloom@bu.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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