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

• Status: Completed
• Trial end date: 2004-08-01
• Target enrollment: 0
• Participant gender: All

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) in a nicotine-dependent adolescent population.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute on Drug Abuse (NIDA)
• Treatments: Nicotine

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