Safety, Tolerability and Efficacy of the Nicotine Patch and Gum for the Treatment of Adolescent Tobacco Dependence

Completed · Phase 2/Phase 3

Conditions studied: Tobacco Dependence

In brief

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) in a nicotine-dependent adolescent population.

Key facts

Study ID

NCT01208935

Run by

National Institute on Drug Abuse (NIDA)

People needed

157

Starts

1999-08-01

Expected to finish

2004-08-01

Last updated by the study team

2017-01-12

Who can join

Age: 13 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Teen Tobacco Addiction Research Clinic — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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