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:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT00365508
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Smokes at least 10 cigarettes a day on average for the past year
* No prior diagnosis of cancer (unless completed treatment AND no evidence of disease within the past 5 years)
* Able to use nicotine replacement therapy
PATIENT CHARACTERISTICS:
* Able to communicate in English
* Must reside in the geographic area for ≥ 6 months
* Current asthma, ulcer, or diabetes allowed provided medical clearance from the participant's physician is obtained
* No evidence of drug or alcohol abuse
* No known HIV positivity
* No heart disease, including any of the following:
* Current diagnosis of coronary artery disease
* Abnormal heart rhythm or an arrhythmia
* Heart failure
* Heart valve disease
* Congenital heart disease
* Heart muscle disease or cardiomyopathy
* Pericardial disease
* Aorta disease
* Vascular disease
* Myocardial infarction
* High blood pressure (defined as blood pressure \> 140/90 mm Hg) not receiving antihypertensive medication
* History of or current high blood pressure controlled by antihypertensive medication and having medical clearance from physician allowed
* No allergy to adhesive tape or latex
* Not pregnant or nursing
* Negative pregnancy test
* Fertile participants must use effective contraception during and for ≥ 1 month prior to and after completion of study treatment
PRIOR CONCURRENT THERAPY:
* At least 30 days since prior and no concurrent benzodiazepine (e.g., diazepam, alprazolam, or lorazepam)
* At least 6 months since prior antiretroviral medications
* At least 6 months since prior and no concurrent medication for depression (e.g., phenelzine sulfate, pargyline hydrochloride, tranylcypromine sulfate, paroxetine hydrochloride, sertraline hydrochloride, fluoxetine hydrochloride)
* No concurrent antipsychotics (e.g., lithium) or theophylline
* No concurrent substance abuse treatment
* No concurrent bupropion hydrochloride
* No other concurrent pharmacologic aid or any other form of formal assistance for smoking cessation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00365508
Study Brief:
Protocol Section:
NCT00365508