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 @ 4:14 PM
Ignite Modification Date:
2025-12-24 @ 4:14 PM
NCT ID:
NCT01063166
Eligibility Criteria:
Inclusion Criteria:
* (a) male and female Caucasian volunteers aged 18 years/0 months to 19 years/11 months;
* (b) written informed consent by the subject;
* (c) habitual social drinking during the two months preceding participation, defined by at least one drinking day in any two weeks-interval;
* (d) at least one prior experience of alcohol intoxication
* (e) being able to abstain from tobacco use for four hours without developing nicotine withdrawal symptoms;
* (f) effective contraception in female participants;
* (g) consenting to abstain from any illegal substance use for 2 weeks prior to participation;
* (h) living within 15 km (9.5 miles) from downtown Dresden;
* (i) sufficient information concerning alcohol use in both parents and in at least four second-degree relatives
Exclusion Criteria:
* (a) prior medical treatment due to alcohol use;
* (b) current or prior history of any serious disease, including CNS, cardiovascular, respiratory, gastrointestinal, hepatic, renal, endocrine, alcohol or drug dependence, but not alcohol abuse;
* (c) current history of Axis-I psychiatric illness, including premenstrual dysphoric disorder;
* (d) current or prior history of alcohol-induced flushing reactions;
* (e) positive urine screen for cannabinoids, cocaine, amphetamines, opiates, or benzodiazepines;
* (f) light or non-drinkers: averaging less than 2 standard drinks per week in the preceding two months;
* (g) intention to become pregnant
* (h) pregnancy or positive urine pregnancy screening or breast-feeding;
* (i) any alcohol intake on the test day or the day before;
* (k) use of medications known to interact with alcohol within 2 weeks of the study;
* (l) positive hepatitis or HIV at screening, provided the subject consented to these tests
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
19 Years
Study:
NCT01063166
Study Brief:
Protocol Section:
NCT01063166