Nicotine Replacement Therapy (NRT) and Bupropion Mechanisms of Effectiveness in Smokers
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to better characterize differences in mood, attention, brain
      activation patterns underlying the beneficial effects of pharmacological treatments
      previously demonstrated to be help individuals successfully quit tobacco smoking. Smokers
      will be randomly assigned to one of three treatments: 1) bupropion sustained release (SR), 2)
      nicotine patch, or 3) placebo patches plus pills across a 45-day period with a 3-week
      intensive post-treatment follow-up. In addition, 20 percent of the subjects will be
      randomized to a delayed-quit control group.
    

Detailed description: 
      The first aim of this revised proposal is to accurately assess the duration and trajectories
      of smoking abstinence symptoms and associated biobehavioral indices across 66 days of
      quitting smoking in 3 different treatment groups: 1) bupropion SR (BUP), 2) transdermal
      nicotine patch (TNP), and 3) placebo patch plus placebo pill. Study sensitivity and accuracy
      will be maximized by using procedures designed to maximize abstinence and minimize study
      dropout. The second aim is to characterize brain and psychological mechanisms by which BUP
      and TNP promote abstinence. While the efficacies of BUP and TNP in promoting smoking
      abstinence have been repeatedly demonstrated, little is known about the mechanisms mediating
      this efficacy. The final primary goal of this competitive continuation proposal is to
      characterize individual differences in psychological and brain mechanisms mediating the
      beneficial effects of BUP and TNP on smoking abstinence and withdrawal symptoms. A secondary
      goal is to assess the ability of a battery of innovative brain and biobehavioral measures of
      attention and affect to predict relapse.

      To achieve these goals, the effects of quitting smoking with or without the help of TNP and
      BUP will be assessed intensively across 66 days of abstinence. Dependent measures will be
      mood, vigilance, attentional bias to smoking and emotional stimuli, and related physiological
      measures (resting EEG activation and activation asymmetry indices of affective states and
      traits, and event-related potential activity elicited by emotional and smoking stimuli).
      Smokers will be randomly assigned to one of three immediate-quit groups (N = 60 per group):
      (1) bupropion + placebo patch, (2) placebo pill + nicotine patch, and (3) placebo patch +
      placebo pill; or to a fourth (control) group (N = 40) that will quit after the final
      experimental session (after the other subjects have completed their 66-day* abstinence
      period). Subjects in the 3 treatment groups and the control group will have the same set of
      biobehavioral measures assessed during the experimental sessions at the same points in time.
      It is hypothesized that BUP and TNP will have both common and unique mechanisms by which they
      reduce withdrawal symptoms and that gender and personality traits will moderate the effects
      of these treatments. (Note.* To avoid final-session mood and arousal effects subjects will
      actually quit for 67 days, but biobehavioral measures will be collected on the 66th day of
      abstinence.)
    

Intervention name(s): Bupropion SR; Nicotine Patch; Placebo Patch and Placebo Pill
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 150 encapsulated pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down.; Nicotine patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days; 150 encapsulated placebo pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down. Placebo patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days. The placebo patches were given beginning 1st day cessation: 21 mg size (but actually placebo)/24 days, 14 mg size (actually placebo)/ 14 mg size (actually placebo) 14 days/, 7 mg size (actually placebo)/7 days
Other intervention name(s): ZybanSR; NicodermCQ; Placebo
Intervention MeSH terms: Bupropion; Nicotine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Electroencephalography; nicotine; bupropion; attention; drug withdrawal symptoms