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 @ 2:39 PM
Ignite Modification Date:
2025-12-24 @ 2:39 PM
NCT ID:
NCT03879759
Eligibility Criteria:
Inclusion Criteria:
* Male and female patients between the ages of 18 and 65 meeting DSM-IV criteria for current alcohol use disorder (this is an exclusion for the healthy control sample)
* Able to understand and sign written informed consent
* Must have a stable residence and be able to identify an individual who could locate subject if needed
* Admitted for medical detoxification from alcohol (withdrawal study only)
* Blood alcohol concentration of 0.00 (if completing brain imaging session)
* Express a desire to achieve abstinence or to greatly reduce alcohol consumption (relapse prevention study only)
Exclusion Criteria:
* Clinically significant comorbidities or medical disease that might interfere with the evaluation of the study medication or present a safety concern.
* Pregnant women and women of childbearing potential who do not practice a medically acceptable form of birth control
* Women who are breastfeeding
* Dependence on any substance other than nicotine
* Court-mandated participation in alcohol treatment or pending incarceration (relapse prevention study only)
* Treatment/ingestion during the previous week of benzodiazepines or other sedative-hypnotic medications or history of recent chronic treatment with sedative-hypnotic medications (withdrawal study only)
* Dependence on any substance other than nicotine
The following exclusion criteria are only applicable to participants undergoing the brain imaging session:
* Extreme obesity
* Pregnant or have any reason to believe they are pregnant;
* Previous brain surgery;
* Ever employed as a machinist, a welder or a metal worker;
* Epilepsy
* Metal items such as pacemakers; aneurysm clips in the brain; metal dental implants; metallic fragments in the eye or anywhere else; insulin pump; metal implants; hearing aid or a prosthetic device.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03879759
Study Brief:
Protocol Section:
NCT03879759