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 @ 10:41 PM
Ignite Modification Date:
2025-12-24 @ 10:41 PM
NCT ID:
NCT00873535
Eligibility Criteria:
Inclusion Criteria: Heavy Smokers/Heavy Drinkers
* Treatment seeking smokers
* Age 18 to 65 years
* Smoke ≥ 10 cigarettes per day
* Fagerstrom Test of Nicotine Dependence score \> 3
* Alcohol Use Disorders Identification Test (AUDIT) \> 8
* Drink \> 25 drinks per week for males or \> 20 drinks per week for females
* Able to provide written informed consent
Inclusion Criteria (Heavy Smokers/Social Drinkers):
* Treatment seeking smokers
* Age 18 to 65 years
* Smoke ≥ 10 cigarettes per day
* Fagerstrom Test of Nicotine Dependence score \> 3
* Alcohol Use Disorders Identification Test(AUDIT) \< 8
* Drink \< 14 drinks per week for males or \< 9 drinks per week for females
* Able to provide written informed consent
Exclusion Criteria (Heavy Smokers/Heavy Drinkers):
* Any medical condition requiring immediate investigation or treatment
* Beck Depression Inventory score \>16
* Insulin-dependent diabetes
* Drink \> 70 standard alcoholic drinks per week for males or drink \> 52 standard alcoholic drinks per week for females
* Pregnancy or lactation
* Current DSM-IV Axis 1 psychiatric disorder
* Regular use of any therapeutic or recreational psychoactive drug use during the last three months or other substance use disorder, with the exception of tobacco and alcohol.
Exclusion Criteria (Heavy Smokers/Social Drinkers):
* Any medical condition requiring immediate investigation or treatment
* Beck Depression Inventory score \>16
* Insulin-dependent diabetes
* Drink \> 14 standard alcoholic drinks per week for males or \> 9 standard alcoholic drinks per week for females
* Pregnancy or lactation
* Current DSM-IV Axis 1 psychiatric disorder
* Regular use of any therapeutic or recreational psychoactive drug use during the last three months or other substance use disorder, with the exception of tobacco.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00873535
Study Brief:
Protocol Section:
NCT00873535