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 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT03152760
Eligibility Criteria:
* INCLUSION CRITERIA:
* Male or female individuals 21-70 years old (inclusive)
Specific For Abstinent Group; AB
* Current Alcohol Use Disorder (AUD) by DSM-5 criteria
* Being alcohol abstinent for at least 4 weeks, with a minimum of 2 weeks in a non-protective environment at the time of study screening.
Specific For Current Drinking Group; CD
* Current Alcohol Use Disorder (AUD) by DSM-5 criteria
* Participants not seeking treatment for their alcohol use will be included.
* Satisfying heavy drinking criteria during the 4-weeks prior to screening (i.e., for men, \>14 standard drinks in any one week or greater than or equal to 4 drinks per occasion at least once per month over the past 30 days; for women, \>7 drinks per week or greater than or equal to 3 drinks per occasion at least at least once per month over the past 30 days) and any drinking during the 2-day prior to signing the study-specific consent.
Specific For Healthy Control Group; HC
* No current or past diagnostic of AUD by DSM-5 criteria
* Moderate alcohol consumers: i.e., up to 1 drink per day on average and not meeting NIAAA criteria for:
* -heavy (i.e., for men, \>14 standard drinks in any one week or greater than or equal to 4 drinks per occasion at least once per month over the past 30 days; for women, \>7 drinks per week or greater than or equal to 3 drinks per occasion at least at least once per month over the past 30 days)
* -or binge drinking (i.e., drinking 5 or more standard drinks on the same occasion on at least 1 day in the past 30 days for both male and female)
If any answer is No , subject may not be enrolled.
EXCLUSION CRITERIA:
Exclusion - All Participants (at the time subject are evaluated for this protocol)
* Current pregnancy or lactation
* Positive Urine Drug Test for illegal drugs
* Body Mass Index (BMI) less than or equal to 18.5 kg/m(2) or BMI greater than or equal to 40 kg/m(2)
* Presence of active implantable electronic devices (e.g., defribillators, pumps, pacemakers)
* Current medical history of the following medical conditions:
--diabetes; chronic gut inflammatory diseases; GI or any other type of cancer; short bowel syndrome; conditions requiring parenteral nutrition;
* Diarrhea or other symptoms of possible enteritis in the past 7 days (self-reported)
* Recent history of sigmoidoscopy or colonoscopy (past 30 days)
* Current use (past 90 days) of the following medications:
--oral antimicrobials (specifcally: antiviral, antifungal, or antibiotics); prebiotics; probiotics; laxatives; antispasmodic drugs; oral, IM or IV steroids
* Any other reason or clinical condition that the PI, or Medical Advisory Investigator (MAI) considers unsafe or not in the best interest of the study research integrity
If any answer is Yes , subject may not be enrolled.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
70 Years
Study:
NCT03152760
Study Brief:
Protocol Section:
NCT03152760