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 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT03610633
Eligibility Criteria:
Inclusion Criteria:
1. Age 21-40.
2. Subjects must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
3. Meets the DSM 5 criteria for current alcohol use disorder.
4. Reports drinking on average, at least 20 standard alcoholic drinks per week for at least the past three months.
5. Currently not engaged in, and does not want treatment for, alcohol related problems.
6. Lives within 50 miles of the study site.
7. Subjects must consent to random assignment.
8. Able to maintain abstinence for two days (without the aid of detoxification medications) as determined by self report and breathalyzer measurements Subjects must also have a negative breathalyzer urine drug screen at the study visit.
9. Subjects must consent to the study visit which includes an outpatient admission to the Addiction Sciences Division and completing one functional magnetic resonance imaging (fMRI) scanning session.
Exclusion Criteria:
1. Currently meets DSM 5 criteria for any other psychoactive substance use disorder.
2. Is determined
3. Any psychoactive substance use (except marijuana and nicotine) within the last 30 days by self-report and urine drug screen. For marijuana, no use within the last seven days by verbal report and negative (or decreasing) urine THC levels.
4. Meets DSM 5 criteria for current major depression, panic disorder, obsessive-compulsive disorder, post traumatic stress syndrome, bipolar affective disorder, schizophrenia, dissociate disorders, eating disorders, and any other psychotic disorder or organic mental disorder.
5. Has current suicidal ideation or homicidal ideation.
6. Has the need for maintenance or acute treatment with any psychoactive medication including anti-seizure medications and medications for ADHD.
7. Is currently taking medication known to affect alcohol intake (e.g., disulfiram, naltrexone, acamprosate, topiramate).
8. Has clinically significant medical problems such as cardiovascular, renal, GI, neurological (e.g. seizure disorder) or endocrine problems that would impair participation or limit medication ingestion.
9. Has past history of alcohol related medical illness such as gastrointestinal bleeding, pancreatitis, peptic ulcer, hepatic cirrhosis or alcoholic hepatitis.
10. Has hepatocellular disease indicated by elevations of SGPT (ALT) or SGOT (AST) greater than 2.5 times normal at screening.
11. Females of childbearing potential who are pregnant (by urine HCG), nursing, or who are not using a reliable form of birth control.
12. Has current charges pending for a violent crime (not including DUI related offenses).
13. Does not have a stable living situation.
14. Presence of ferrous metal in the body, as evidence by metal screening and self-report.
15. Severe claustrophobia or morbid obesity that preclude placement in the MRI scanner.
16. History of head injury with \>2 minutes of unconsciousness.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
40 Years
Study:
NCT03610633
Study Brief:
Protocol Section:
NCT03610633