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 @ 2:56 AM
Ignite Modification Date:
2025-12-25 @ 2:56 AM
NCT ID:
NCT01492933
Eligibility Criteria:
* INCLUSION CRITERIA (Light Drinkers)
1. In good health as determined by medical history, physical exam, ECG and lab tests;
2. Between 21 and 45 years of age;
3. Currently consuming between 1 and 10 drinks per week for females and 1 and 14 drinks per week for males.
EXCLUSION CRITERIA (Light Drinkers)
1. Have liver function tests (AST, ALT, GGT, ALP) 3-times the upper limit of normal (ULN); or have Total Bilirubin above 1.5 ULN and Albumin below 3.5 g/dL.
2. Have fulfilled DSM-IV criteria for a current or past major psychiatric disorder including alcohol or other substance dependnece (excluding nicotine);
3. Have a Body Mass Index (BMI) value over 35;
4. Unable to stop taking any prescribed, non-prescribed, or over-the-counter medication or drugs 3 days prior to study days (excluding oral contraceptive agents). If a subject is taking a prescribed medication (excluding oral contraceptive agents) that is not take-as-needed they will be excluded from participation;
5. Are pregnant, as determined by a negative pregnancy test, or lactating;
6. Report to have a "facial flushing" response to the consumption of alcohol;
7. Have never consumed at least two standard drinks of alcohol within one hour;
8. Have ferromagnetic objects in their bodies, which might be adversely affected by MRI including implanted pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent eye liner or small metal fragments in the eye that welders and other metal works may have any doubt about presence of these objects will result in exclusion from this study);
9. 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;
10. Unwilling to abstain from alcohol for at least 2 days prior to the studies.
INCLUSION CRITERIA (Heavy Drinkers)
1. In good health as determined by medical history, physical exam, ECG and lab tests;
2. Between 21 and 45 years of age;
3. Currently consuming 15+ drinks for females and 20+ drinks for males;
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, participants 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 liver function tests (AST, ALT, GGT, ALP) 3-times the upper limit of normal (ULN); or have Total Bilirubin above 1.5 ULN and Albumin below 3.5 g/dL.
2. Have fulfilled DSM-IV criteria for a current or past major psychiatric disorder, including any substance dependence (excluding alcohol or nicotine) at any time;
3. Have a Body Mass Index (BMI) value over 35;
4. Unable to stop taking any prescribed, non-prescribed, or over-the-counter medication or drugs 3 days prior to study days (excluding oral contraceptive agents). If a subject is taking a prescribed medication (excluding oral contraceptive agents) that is not take-as-needed they will be excluded from participation;
5. Are pregnant, as determined by a negative pregnancy test, or lactating;
6. Report to have a "facial flushing" response to the consumption of alcohol;
7. Have never consumed at least two standard drinks of alcohol within one hour;
8. Have ferromagnetic objects in their bodies, which might be adversely affected by MRI including implanted pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent eye liner or small metal fragments in the eye that welders and other metal works may have any doubt about presence of these objects will result in exclusion from this study);
9. 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;
10. Unwilling to abstain from alcohol for at least 2 days prior to the studies.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
45 Years
Study:
NCT01492933
Study Brief:
Protocol Section:
NCT01492933