Duke University Medical Center
Durham, North Carolina, 27705, United States
NCT Number: NCT02927847
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.
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Notify MeSmokers 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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Other names: Nicoderm CQ
For 1 month prior to their quit date, participants will switch to smoking SPECTRUM Nicotine Research Cigarettes instead of their usual brand.
Other names: Very Low Nicotine Content Cigarettes
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.
Other names: BA
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.
Time frame: baseline, week 5
Effects of BA+VLNC (vs. VLNC Only) on pre-quit changes in fMRI BOLD response to monetary reward anticipation. BOLD signal change is estimated from the contrast of monetary reward anticipation vs neutral anticipation, and extracted from voxels within the ventral striatum at each time point.
Time frame: baseline, week 5
Effects of BA+VLNC (vs. VLNC Only) on pre-quit changes in fMRI BOLD response to smoking reward anticipation. BOLD signal change is estimated from the contrast of smoking reward anticipation vs neutral anticipation, and extracted from voxels within the ventral striatum at each time point.
Time frame: weeks 6 to 13
Relapse is defined as return to 7 consecutive days of smoking.
Maggie M Sweitzer, PhD
Other
Targeting Reward Dysfunction as a Mechanism to Improve Smoking Cessation
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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