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 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT02301351
Eligibility Criteria:
Inclusion Criteria:
* Male and female smokers who are between 21 and 60 years of age and self-report smoking at least 5 cigarettes per day for at least the past 12 months.
* Smokers of primarily non-menthol, Marlboro red or gold type cigarettes.
* Not using any forms of nicotine other than cigarettes.
* Not currently undergoing smoking cessation treatment or tying to quit.
* Able to communicate fluently in English (speaking, writing, and reading).
* Plan to remain in the area over the duration of the trial.
* Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form.
Exclusion Criteria:
Smoking Behavior.
* Use of any nicotine products other than cigarettes.
* Enrollment or plans to enroll in a smoking cessation program over the duration of the trial.
* Provide a Carbon Monoxide (CO) reading less than 5 parts per million (ppm) at Day 0.
Alcohol/Drugs.
* History of substance abuse (other than nicotine) in the past 12 months and/or currently receiving medical treatment for substance abuse.
* Current alcohol consumption that exceeds 25 standard drinks/week.
* Provide a breath alcohol concentration (BrAC) reading greater than .000 at Day 0.
Medical.
* Women who are pregnant, planning a pregnancy, and/or lactating.
* Any impairment including, but not limited to, visual, physical, and/or neurological impairments preventing the completion of procedures included within this protocol. Notable impairments will be evaluated by the Principal Investigator and eligibility will be determined on a case-by-case basis.
* Color blindness.
* Serious or unstable disease within the past 12 months (e.g. heart disease, cancer). Applicable conditions will be evaluated by the Principal Investigator and eligibility will be determined on a case-by-case basis.
Psychiatric.
* Lifetime history or current diagnosis of psychosis, bipolar disorder, and/or schizophrenia.
* Current diagnosis of major depression. Subjects with a history of major depression, in remission for 6 months or longer, are considered eligible.
Other.
* Any medical condition, extenuating circumstance, illness, disorder, adverse event (AE), and/or concomitant medication that could compromise participant safety and/or completion of the study procedures, as determined by the Principal Investigator. Subjects may be deemed ineligible or withdrawn for any of the aforementioned reasons at any point throughout the study.
* Non-compliance with the protocol and/or study design as determined by the Principal Investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
60 Years
Study:
NCT02301351
Study Brief:
Protocol Section:
NCT02301351