NCT02927847

Neuroimaging Reward, Behavioral Treatment, and Smoking Cessation

Targeting Reward Dysfunction as a Mechanism to Improve Smoking Cessation

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Maggie M Sweitzer, PhD · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Smoking

Interventions

Type	Name	Description
DRUG	Nicotine Patch	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).
DRUG	SPECTRUM Nicotine Research Cigarettes (.03 mg)	For 1 month prior to their quit date, participants will switch to smoking SPECTRUM Nicotine Research Cigarettes instead of their usual brand.
BEHAVIORAL	Behavioral Activation	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.
BEHAVIORAL	Supportive Counseling	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.

Timeline

• Start date: 2017-02-01
• Primary completion: 2021-05-28
• Completion: 2022-05-27
• First posted: 2016-10-07
• Last updated: 2022-06-28
• Results posted: 2022-06-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study