Comparison of Standard Versus Extended Nicotine Patch Therapy for Smoking Cessation

2010-07-15 17:00:00 | BioPortfolio


This randomized double-blind, placebo-controlled will determine the relative efficacy of standard versus extended transdermal nicotine (TN) therapy for smoking cessation. After completing the eligibility screening, 600 treatment-seeking smokers will be randomized to receive either standard treatment (ST) with TN (21mg x 8 weeks, placebo x 16 weeks) or extended treatment (ET) with TN (21mg x 24 weeks). All participants will receive behavioral counseling. The primary outcome will be biochemically verified abstinence from smoking at the end of treatment (week 24). Secondary outcomes include abstinence at week 28 (4 weeks after treatment is discontinued), and time to failure. We hypothesize that ET will produce significantly higher quit rates than ST; however, the benefit of ET will last only so long as treatment is continued. Support for this hypothesis would indicate that maintenance therapy with TN should be considered.


Please see brief summary.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Tobacco Use Cessation


Standard Patch Treatment, 24-weeks of nicotine patch


Tobacco Use Research Center
United States


Active, not recruiting


University of Pennsylvania

Results (where available)

View Results


Published on BioPortfolio: 2010-07-15T17:00:00-0400

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