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Influence of Age and Sex on Alcohol Metabolism and Acute Responses
NCT00070577 · View on ClinicalTrials.gov ↗
Study Summary
This study will examine age and sex differences in alcohol metabolism and the effects of alcohol. Men and women differ in their ability to metabolize alcohol, possibly due to differences between men and women in lean body mass, liver size, or the activity of enzymes that act on alcohol in the liver. Also, older men and women are thought to be more sensitive to alcohol, although the reasons for this are not clear. Healthy men and women between 21 and 25 years of age and between 55 and 65 years of age who are social drinkers may be eligible for this study. Candidates will be screened with questionnaires about their general and mental health, alcohol use, and family history of alcohol use and problems. They will have a physical examination, electrocardiogram (EKG), routine blood tests, urinalysis to test for drugs of abuse, and a blood test to study the gene responsible for enzymes that metabolize alcohol. Younger women will have a urine pregnancy test and older women will have a test to confirm post-menopausal status. Participants will have two study sessions at the NIH Clinical Center outpatient clinic. They come to the clinic by taxi and, upon arrival, take a breathalyzer test for any measurable alcohol levels. They are then given breakfast, after which two catheters (plastic tubes) are placed, one in a vein in each arm. One tube is used to collect blood samples for measuring hormone levels; the other is for infusing alcohol. The infusion is adjusted so that the breath alcohol level is held constant for about 3 hours at a moderate level. Baseline measurements are taken before the infusion begins. During and after the infusion, the participants fill out questionnaires about their moods and feelings. Breath alcohol level and heart rate measurements are monitored frequently. After the test, participants remain in the clinic until their breath alcohol level drops below 0.02 g/L (generally 2 to 3 hours after the infusion stops). They are given lunch and then sent home
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2003-09-29 |
| Est. Completion | 2011-05-03 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00070577
The ClinicalTrials.gov registry entry for NCT00070577 describes a study currently listed as completed. It is categorized as an unspecified phase, 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 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 118 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Metabolism appearing as the primary indexed condition, and to 0 interventions. 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: NCT00070577 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. 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 NCT00070577 about?
NCT00070577 is a clinical study titled "Influence of Age and Sex on Alcohol Metabolism and Acute Responses". This study will examine age and sex differences in alcohol metabolism and the effects of alcohol. Men and women differ in their ability to metabolize alcohol, possibly due to differences between men and women in lean body mass, liver size, or the activity of enzymes that act on alcohol in the liver....
What is the current status of trial NCT00070577?
This trial is currently completed. The enrollment target is 65 participants. The study started on 2003-09-29. Estimated completion is 2011-05-03.
What conditions does trial NCT00070577 study?
This clinical trial studies the following conditions: Metabolism. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT00070577?
This trial is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 118 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00070577 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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