Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT00074360
Eligibility Criteria:
* INCLUSION CRITERIA LIGHT DRINKERS:
1. in good health.
2. between 21 and 45 years of age.
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3. Currently consuming between 1 and 14 drinks per week.
EXCLUSION CRITERIA LIGHT DRINKERS:
1. have an abnormal physical exam and/or have laboratory values outside of normal ranges;
2. have fulfilled DSM-IV criteria for ethanol or other substance dependency (excluding nicotine) at any time;
3. have fulfilled DSM-IV criteria for a current or past major psychiatric disorder (DSM-IV Axis I) or who have ever had a head injury requiring hospitalization.
4. are over or under 20% of ideal body weight;
5. have taken any prescribed, non-prescribed, or over-the-counter medications or drugs within 14 days prior to the study days (excluding oral contraceptive agents);
6. are pregnant;
7. report to have a "facial flushing" response to the consumption of ethanol;
8. have never consumed at least two standard drinks of ethanol within one hour.
9. have ferromagnetic objects in their bodies, which might be adversely affected by MRI (e.g., surgical clips, metal fragments in or near brain, eye or blood vessels, cardiac or neurological pacemaker, cochlear or eye implant). Any doubt about presence of these objects will result in exclusion from this study.
10. Additionally, subjects will be asked to abstain from ethanol for at least 2 days prior to the studies.
11. Regular tobacco users will be excluded from the study in order to avoid nicotine withdrawal symptoms. Occasional (not daily) use of tobacco products is acceptable.
INCLUSION CRITERIA HEAVY DRINKERS:
1. in good health.
2. between 21 and 45 years of age.
3. currently consuming between 20 and 40 drinks per week.
4. not regularly abstinent for more than 3 days per week, but have abstained from alcohol for 3 consecutive days without experiencing withdrawal symptoms.
5. able to provide a plausible history that they can abstain from alcohol without significant withdrawal symptoms when coming to the clinic. In addition, each participant will be asked to quantify their worst withdrawal symptoms using the Clinical Institute Withdrawal Assessment (CIWA) Instrument. Participants who score 8 or above will not be enrolled in the protocol.
6. not seeking treatment for their alcohol consumption.
EXCLUSION CRITERIA HEAVY DRINKERS:
1. have an abnormal physical exam and/or have laboratory values outside of normal ranges;
2. have fulfilled DSM-IV criteria for any substance dependency (excluding alcohol or nicotine) at any time;
3. have fulfilled DSM-IV criteria for a current or past major psychiatric disorder or who have ever had a head injury requiring hospitalization.
4. are over or under 20% of ideal body weight;
5. have taken any prescribed, non-prescribed, or over-the-counter medications or drugs within 14 days prior to the study days (excluding oral contraceptive agents);
6. are pregnant;
7. report to have a "facial flushing" response to the consumption of ethanol;
8. have never consumed at least two standard drinks of ethanol within one hour.
9. have ferromagnetic objects in their bodies, which might be adversely affected by MRI (e.g., surgical clips, metal fragments in or near brain, eye or blood vessels, cardiac or neurological pacemaker, cochlear or eye implant). Any doubt about presence of these objects will result in exclusion from this study.
10. Additionally, subjects will be asked to abstain from ethanol for at least 2 days prior to the studies.
11. Regular tobacco users will be excluded from the study in order to avoid nicotine withdrawal symptoms. Occasional (not daily) use of tobacco products is acceptable.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
45 Years
Study:
NCT00074360
Study Brief:
Protocol Section:
NCT00074360