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 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT02903251
Eligibility Criteria:
Inclusion Criteria:
1. At least one prior episode 2 days or longer in duration during which the subject experienced withdrawal symptoms that caused significant incapacitation (e.g., inability to work or do normal activities) OR at least one prior inpatient or outpatient medical detoxification during which the subject exhibited withdrawal symptoms of sufficient magnitude that sedative-hypnotic or anticonvulsant medication was required at least once on 2 consecutive days after cessation of or reduction in the use of alcohol following 2 weeks or more of heavy daily consumption
2. average consumption of 8-30 standard drinks per day for at least 2 weeks prior to enrollment in the study;
3. consenting to participate in the study;
4. have residency in Trøndelag County after discharge
Exclusion Criteria:
1. chronic treatment with sedative-hypnotic medications such as benzodiazepines or z-hypnotics;
2. dependence on substances other than alcohol, nicotine or caffeine;
3. inadequately treated, unstable and/or compromising medical or psychiatric conditions;
4. low body weight (BMI \< 17) or history of anorexia nervosa or bulimia in the past 2 years;
5. pregnancy; parturition or breast-feeding in the past 6 months;
6. inability to read well enough to complete study questionnaires determined by whether the prospective subject can read the consent form without help and correctly answer basic questions about information in the consent form;
7. no alcohol in the blood and \> 15 h since last intake of alcohol;
8. prior inclusion and participation in the same study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02903251
Study Brief:
Protocol Section:
NCT02903251