Status:
COMPLETED
Safety, Tolerability and Efficacy of the Nicotine Patch and Gum for the Treatment of Adolescent Tobacco Dependence
Lead Sponsor:
National Institute on Drug Abuse (NIDA)
Conditions:
Tobacco Dependence
Eligibility:
All Genders
13-17 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to test the safety, tolerability, compliance and efficacy of two different forms of nicotine replacement therapy (NRT) (the nicotine transdermal patch and the nicotine gum...
Detailed Description
We hypothesize that two nicotine replacement delivery systems (patch and gum) are both safe and efficacious for the treatment of adolescent nicotine dependence. Consequently, use of both the patch and...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2004
Estimated Enrollment :
157 Patients enrolled
Trial Details
Trial ID
NCT01208935
Start Date
August 1 1999
End Date
August 1 2004
Last Update
January 12 2017
Active Locations (1)
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1
Teen Tobacco Addiction Research Clinic
Baltimore, Maryland, United States, 21224