Evaluation of a Tailored Smoking Cessation Treatment Algorithm Based on Initial Treatment Response and Genotype
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    


Intervention name(s): Nicotine Patches; Nicotine patches, then bupropion & nicotine patches (Pre-Quit); Nicotine patches, then varenicline (Pre-Quit); Nicotine patches, then nicotine patches (Pre-Quit); Nicotine patches, then bupropion & nicotine patches (Post-Quit); Nicotine patches, then varenicline (Post-Quit); Nicotine patches, then nicotine patches (Post-Quit)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 21mg (1 patch) or 42mg (2 patches)nicotine patches for first five weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks.; 21mg (1 patch) or 42mg (2 patches) nicotine patches for first week (# of daily patches based on baseline carbon monoxide level); starting with week 2: 150mg of bupropion once daily and 21mg (1 patch) or 42mg (2 patches)nicotine patches for first 3 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg (1 patch) or 42mg (2 patches)nicotine patches for 3 weeks and 4 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg nicotine patch for 4 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks.; 21mg (1 patch) or 42mg (2 patches) nicotine patches for first week (# of daily patches based on baseline carbon monoxide level); starting with week 2: 0.5mg of varenicline once daily for first 3 days; 0.5mg of varenicline twice daily for the next 4 days; and 1mg of varenicline twice daily for the remainder of the study (11 weeks); 21mg (1 patch) or 42mg (2 patches)nicotine patches for first five weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks.; 21mg (1 patch) or 42mg (2 patches) nicotine patches for first three weeks (# of daily patches based on baseline carbon monoxide level); starting with week 4: 150mg of bupropion once daily and 21mg (1 patch) or 42mg (2 patches) nicotine patches for first 3 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg (1 patch) or 42mg (2 patches) nicotine patches for 3 weeks and 4 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg nicotine patch for 4 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks.; 21mg (1 patch) or 42mg (2 patches) nicotine patches for first three weeks (# of daily patches based on baseline carbon monoxide level); starting with week 4: 0.5mg of varenicline once daily for first 3 days; 0.5mg of varenicline twice daily for the next 4 days; and 1mg of varenicline twice daily for the remainder of the study (11 weeks); 21mg (1 patch) or 42mg (2 patches) nicotine patches for first seven weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks.
Other intervention name(s): NicoDermCQ; Zyban; NicoDermCQ; Chantix; NicoDermCQ; NicoDermCQ; Zyban; NicoDermCQ; Chantix; NicoDermCQ; NicoDermCQ
Intervention MeSH terms: Bupropion; Nicotine; Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Smoking Cessation; Chantix; varenicline; Nicotine Replacement Therapy; Nicotine Patches; Zyban; bupropion; Quit Smoking