Smoking Cessation Clinical Trial
Official title:
Evaluation of a Tailored Smoking Cessation Treatment Algorithm Based on Initial Treatment Response and Genotype
Nicotine replacement therapy (NRT) is a well-tolerated and efficacious smoking cessation
treatment, and yet many smokers fail to quit using NRT. Many of these smokers may benefit
from prescription treatment alternatives, including Zyban or Chantix. In this study, the
investigators propose to develop and evaluate a stepped-care treatment algorithm that would
evaluate whether smokers who receive treatment with NRT should be supplemented with Zyban or
switched to Chantix only based on: 1) their initial response to NRT; and 2) individual
genetic factors found to predict smoking cessation in other studies evaluating these
treatments. This study is a continuation of our previous studies showing that abstinence
rates can be increased by starting nicotine patch therapy two weeks before the quit date.
The investigators will provide pre-cessation NRT to all participants initially. Those who do
not show a favorable response on early indicators of success (e.g., smoking in the first
week after the target quit-smoking date) will receive "rescue" treatment by having their NRT
treatment supplemented with Zyban , by being switched to treatment with Chantix or will
remain on NRT (control).
The investigators hypothesize that "Rescue" treatment with Zyban in combination with NRT or
Chantix will increase success rates over leaving subjects on NRT when they are NRT
insufficient responders, i.e. they have shown an unfavorable response to NRT in the first
week pre-quit or the first week post-quit.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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