A trial to determine if the elderly are more sensitive to the intoxicating effects of ethanol (alcohol) than younger people regardless of their ages. Increasing evidence shows that the elderly are more sensitive to the intoxicating effects of ethanol than young adults, but few studies have examined the relationship of pharmacokinetics (PK-the way the body absorbs, distributes, metabolizes, and excretes a chemical) and pharmacodynamics (PD-the reaction between drugs and a living system) for ethanol among people of different ages. Studies have been done indicating that the elderly are more sensitive, but lacked detailed PK and PD analysis, had small sample sizes, limited age ranges, exclusion of females, and lacked objective intoxication measures. This trial will attempt to provide more conclusive evidence regarding the effects of age and gender on sensitivity to ethanol by performing PK and PD analysis with a sufficient sample size in subjects of the advanced ages of more than 70 years old and by using objective measures to determine ethanol effects. This study will also provide data needed to plan future studies examining potential mechanisms of the different sensitivities to ethanol in young and old alcoholics. The elderly are a growing segment of the population and research is needed to provide data for possible frequent health problems. The study will involve eight healthy male and eight healthy female volunteers, ages 70-99, not deviating more than 15% above or below ideal weight. They must pass a physical exam with no evidence of active diseases with normal blood pressure, taking no medications that will interact with alcohol, drinking alcohol lightly or moderately, having a normal electrocardiogram (tracing of the heart), and with no history of liver, kidney, heart, lung, stomach, nerve or blood diseases. When subjects enter the Clinical Research Center, they will have a urinalysis testing for drug use and a breath alcohol test. They will complete a questionnaire concerning recent medical history and use of medications. Before dosing, volunteers will receive a snack and then fast for 10 hours. Meals will be served after dosing. Subjects will receive an intravenous infusion of ethanol. Blood samples taken periodically will be used to determine ethanol concentration and other important factors. Blood pressure will be taken and the subjects will be observed for signs of intolerance to the drug or to the procedure. Adverse effects will be reported by the subjects.

Project Start
1999-12-01
Project End
2000-11-30
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
38
Fiscal Year
2000
Total Cost
$648
Indirect Cost
Name
Virginia Commonwealth University
Department
Type
DUNS #
City
Richmond
State
VA
Country
United States
Zip Code
23298
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