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 @ 5:33 PM
Ignite Modification Date:
2025-12-24 @ 5:33 PM
NCT ID:
NCT02049268
Eligibility Criteria:
Inclusion Criteria:
* Male
* 21 to 40 years old
* Physically healthy (normal physical exam, ECG, blood and urine chemistries)
* Light/moderate cigarette smokers (greater than 10-20 cigarettes per week)
* Alcohol drinkers (10 or greater drinks per week)
* Must not be seeking treatment for their alcohol or tobacco use
Exclusion Criteria:
* Female
* Diagnosis of past or current alcohol dependence as assessed by Diagnostic and Statistic Manual, DSM-IV, criteria for alcohol dependence
* Diagnosis of cocaine, sedative, or opiate dependence using DSM-IV criteria
* Current diagnosis of Axis I disorder using DSM-IV criteria, or any Axis I disorder within past 5 years (excluding alcohol abuse, marijuana dependence or abuse)
* Current daily use of antipsychotic, antidepressant, or other psychoactive prescription drug, as well as daily use of non-prescription drugs
* Life threatening or unstable medical illness, or one that can create marked change in mental state
* Heavy caffeine use (greater than 400 mg on a regular, daily basis)
* History of seizure disorder
* Hepatitis B or C positive, or history of i.v. drug use
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
21 Years
Maximum Age:
40 Years
Study:
NCT02049268
Study Brief:
Protocol Section:
NCT02049268