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 @ 10:09 PM
Ignite Modification Date:
2025-12-24 @ 10:09 PM
NCT ID:
NCT01208935
Eligibility Criteria:
Inclusion Criteria:
* History of smoking 11 or more cigarettes per day (cpd) for at least one year
* Fagerström Test for Nicotine Dependence score of 5 and above
* General good health as verified by history, physical, psychiatric examination and screening laboratory tests
Exclusion Criteria:
* History of cardiac disease
* Active dependence on any drug other than nicotine (as assessed by the DUSI)
* Current or past severe psychiatric disorders as per the Diagnostic Interview for Children and Adolescents (DICA-A)
* Current use of tobacco or nicotine containing products other than cigarettes
* Previous use of any nicotine transdermal patch or nicotine gum
* Presence or history of severe skin allergies or dermatoses
* Pregnancy or lactation
* Active oral, dental or jaw mobility problems
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
17 Years
Study:
NCT01208935
Study Brief:
Protocol Section:
NCT01208935