Innovative Interventions for Smoking Cessation

• End of treatment abstinence rate [ Time Frame: 6 week ] [ Designated as safety issue: No ]
  
• End of follow-up abstinence rates [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  

• Time to lapse or relapse to tobacco use [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  
• Effect on nicotine withdrawal [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  
• Exposure to tobacco toxicants [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  
• Exploratory predictors of cessation and relapse [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  

The purpose of this study is to evaluate the effect of a combination of the 21 mg nicotine patch and nicotine-free cigarette compared to the nicotine-free cigarette alone or 21 mg nicotine patch alone on abstinence and withdrawal.

The following primary hypothesis will be tested:

-1)Abstinence rates will be highest and the time to relapse will be the longest in the nicotine-free cigarettes plus nicotine patch condition compared to nicotine patch or nicotine-free cigarettes alone.

Other hypotheses include:

• 1)Greater positive subjective responses to cigarettes will be observed with nicotine-free cigarettes plus patch vs. nicotine-free cigarette;
• 2)Less drop-outs will be observed in the nicotine-free plus patch vs the other two conditions;
• 3)Similar withdrawal symptoms and negative affect will be observed with nicotine-free cigarette condition and the nicotine patch alone condition, and least withdrawal and negative affect with the nicotine-free cigarette plus nicotine patch condition; and
• 4)Less compensatory smoking will be observed in the nicotine-free plus patch condition compared to nicotine-free cigarette alone condition.

Cigarette smokers will be randomized to:

1)denicotinized cigarettes (which provide sensory behavioral aspects of smoking but with no nicotine) plus nicotine patch for 6 weeks; -2)nicotine patch for 6 weeks; or - 3)denicotinized cigarettes alone.

Outcome measures will include cessation assessed at the end of treatment as the primary endpoint and at 12, 16, 24 and 36 weeks post-treatment, time to lapse and relapse to usual brand cigarettes, withdrawal symptoms and craving and biomarkers of toxicant exposure. Predictors of abstinence and treatment response for each of the treatment conditions will be explored.