Neuroimaging Reward, Behavioral Treatment, and Smoking Cessation
Condition: Smoking
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The goal of this study is to evaluate the effects of a smoking cessation intervention
      combining behavioral treatment with low nicotine cigarettes on neuroimaging measures of
      reward function and smoking cessation outcomes. The results of this study will provide
      information about mechanisms contributing to smoking and smoking cessation and will help to
      guide future treatment studies.
    

Detailed description: 
      Smokers who are interested in quitting will be randomly assigned to one of two treatment
      conditions. In the BA +VLNC condition (n = 16) smokers will switch to smoking very low
      nicotine cigarettes (VLNCs) while wearing a 21 mg/d nicotine patch for 5 weeks prior to their
      quit date. They will also participate in weekly behavioral activation (BA) treatment
      sessions. Smokers in the VLNC Only group (n = 19) will undergo the same pharmacological
      pretreatment but will undergo standard counseling and health education instead of BA.
      Following the quit date, both groups will receive standard nicotine replacement therapy. At
      baseline and pre-quit, BOLD response to smoking and non-smoking rewards will be measured
      using fMRI after 24 hr abstinence. Latency to relapse will serve as a continuous clinical
      outcome measure. Participants will also receive follow-up phone calls at 6 months and 12
      months post-quit to assess smoking status.
    

Intervention name(s): Nicotine Patch; SPECTRUM Nicotine Research Cigarettes (.03 mg); Behavioral Activation; Supportive Counseling
Intervention type(s): Drug; Drug; Behavioral; Behavioral
Intervention description(s): Both groups will receive nicotine patches (21 mg/d) to wear for 1 month prior to the quit date. After the quit date, both groups will wear the nicotine patch for 8 weeks (21 mg/d for 4 weeks, 14 mg/d for 2 weeks, and 7 mg/d for 2 weeks).; For 1 month prior to their quit date, participants will switch to smoking SPECTRUM Nicotine Research Cigarettes instead of their usual brand.; Participants in the BA+VLNC group will undergo 8 60-minute behavioral sessions (4 pre-quit, 1 on quit day, and 3 post-quit) including 15 min of standard smoking cessation counseling and 45 minutes of behavioral activation treatment. BA components will include activity monitoring, values assessment, activity scheduling, and social contracts.; Participants in the VLNC Only group will undergo 8 60-minute behavioral sessions (4 pre-quit, 1 on quit day, and 3 post-quit) including 15 min of standard smoking cessation counseling and 45 minutes of supportive counseling and health education. Supportive counseling and health education will include empathic listening as well as informational content on topics of exercise, nutrition, sleep and relaxation.
Other intervention name(s): Nicoderm CQ; Very Low Nicotine Content Cigarettes; BA
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science