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:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT00631020
Eligibility Criteria:
Inclusion Criteria:
Participants must meet all of the following inclusion criteria:
* age of 14-21 years, inclusive
* regular cigarette smoking at least five times a day in the month before entry into the study and initiation of smoking at least 6 months before entry
* A score of 35 or greater on the Cigarette Dependence Scale-12
* youth provide informed assent (for youth \<18 yr) or consent (for youth ≥18 yr) and parents provide informed consent to participate in the project
* documented approval to participate from the participant's treating physician for participants currently receiving treatment for a serious medical or psychiatric condition
* current contact information (address, telephone number), which is needed for follow-up
* able to complete study assessments and participate in the intervention (e.g., lives \< 1 hr. away from the site, has family to participate in the intervention, does not have mental retardation)
* youth or primary caregivers speak English or Spanish
Exclusion Criteria:
Participants must meet none of the following exclusion criteria in order to be eligible to receive optional nicotine replacement:
* smoke less than 5 cigarettes per day
* have serious cardiovascular disease, including uncontrolled hypertension, coronary artery disease, serious cardiac arrhythmias, vasospastic disease, or angina, due to potential cardiovascular effects of nicotine, as determined via the baseline medical history and physical exam
* have a medical condition that could be made worse by treatment with nicotine, including poorly controlled insulin dependent diabetes, uncontrolled hyperthyroidism, pheochromocytoma, severe oropharyngeal, esophageal, or peptic ulcer disease, or severe renal or hepatic impairment as determined via the baseline medical history and physical exam
* have an allergy to adhesive tape or latex or serious dermatologic disease (excluding minor skin conditions such as mild eczema) due to potential for skin allergy to patch
* have a known allergy to nicotine or any component of the nicotine patches
* be receiving treatment with adenosine or bupropion due to potential drug-drug interactions
* be pregnant or sexually active and not using reliable birth control methods consistently (for females)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
21 Years
Study:
NCT00631020
Study Brief:
Protocol Section:
NCT00631020