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:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2025-12-24 @ 11:20 PM
NCT ID:
NCT00851656
Eligibility Criteria:
Inclusion Criteria:
* Female
* Age equal to or greater than 21 years
* Actively breast-feeding
* Willing to drink at least one alcoholic beverage (wine or beer) during study in a controlled setting
* Willing to arrive to the study session prior to consuming any alcoholic beverages within the last 6 hours.
* Willing to attend single session study for 3-4 hours duration until their BAC drops below 0.06%
* Willing to accept designated driver or study-supplied transportation
* Willing to agree to not breast feed their infant for 2 hour following leaving the study session
* English language fluency
Exclusion Criteria:
* Distance of more than 25 miles from study site
* Pregnant (hCG test will be administered prior to alcohol consumption)
* Communicable diseases (e.g., Flu)
* HIV Positive
* History of Alcoholism (Recorded on the CRF)
* Arriving to the study session with a BAC at or below 0.01%
* Any medical condition which precludes the subject from drinking alcohol
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
21 Years
Study:
NCT00851656
Study Brief:
Protocol Section:
NCT00851656