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 @ 9:46 PM
Ignite Modification Date:
2025-12-24 @ 9:46 PM
NCT ID:
NCT02370732
Eligibility Criteria:
Inclusion Criteria:
1. Male or female (approximately 50% each)
2. 21 - 65 years of age
3. In evaluation for Roux-en-Y gastric bypass surgery
4. Able to tolerate alcohol dose
5. Cognitive ability to complete study protocol as assessed at screening
6. Medically stable
Exclusion Criteria:
1. History of or current alcohol use disorder (as assessed at screening)
2. Psychotic or bipolar spectrum disorder (as assessed at screening)
3. Current suicidality (as assessed at screening)
4. Concomitant medication known to significantly interact with alcohol
5. Concomitant medication known to significantly impact driving simulator performance
6. Pregnancy or intending to become pregnant prior to the end of the their participation in the study or breastfeeding
7. Positive urine drug screen
8. Unable to tolerate blood draws
9. Significant risk for developing motion sickness while using the driving simulator
10. Unable to speak English
11. Other factor that would increase participant risk in the protocol in the judgement of the investigators or physician.
12. Participated in an investigational drug study within the past 30 days
13. Is or has an immediate family member that is employeed by the Neuropsychiatric Research Institute
14. Has a pacemaker
15. Insulin dependent diabetes mellitus
16. Smoking defined as regular use of nicotine in the past 6 months
17. A presurgery weight of \> 400lbs at screening appointment or as reported on telephone screen
18. Unable to provide a blood sample at the screening appointment or is assessed to have poor vein quality for IV placement as determined by the research clinical personnel.
19. Laboratory abnormalities defined as a hepatic panel greater than three times the upper limit of normal, or fasting glucose of \< 60 or \>120 mg/dl, or positive pregnancy test.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT02370732
Study Brief:
Protocol Section:
NCT02370732