NCT02837510

Neural Mechanisms Associated With Risk of Smoking Relapse

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will examine how abstinence-induced brain changes contribute to smoking cessation outcomes in treatment-seeking smokers.

Detailed description

Smoking is the greatest preventable cause of mortality and a significant economic burden. Even with the best available treatments, most smokers relapse within days or weeks after a quit attempt. Nicotine replacement therapy, the most widely used pharmacotherapy, yields end of treatment quit rates of \<25% suggesting that managing nicotine withdrawal is not sufficient. To improve quit rates significantly, a more refined mechanistic understanding is needed. Neuroimaging can identify mechanisms underlying behavior change beyond self-report and behavioral measures. Functional magnetic resonance imaging (fMRI) studies show that brief (e.g., 24 hr.) abstinence from smoking produces working memory deficits associated with reduced neural activity in cognitive control circuits. This study will examine how abstinence-induced brain changes contribute to clinical outcomes in treatment-seeking smokers. Using a validated fMRI abstinence challenge paradigm, 200 treatment-seeking smokers will complete two 1-hour pre-treatment fMRI scans: after smoking satiety and after 24 hours of confirmed abstinence. Approximately 50% of participants will complete the smoking session first, followed by the absence session, and the remainder will complete the opposite order (counterbalanced). The investigators will examine brain responses during the performance of tasks probing working memory. Participants will then set a target quit date, receive smoking cessation counseling, and be monitored for 6 months to assess time to relapse using a validated smoking relapse protocol.

Conditions

• Nicotine Addiction

Interventions

Type	Name	Description
BEHAVIORAL	Standard smoking cessation counseling	Participants will discuss reasons for quitting, the model of smoking as a learned habit, triggers for smoking, and trigger management; receive brief training in how to manage withdrawal symptoms and relapse prevention counseling and receive the NCI Clearing the Air self-help smoking cessation booklet. The target quit date (TQD) session will be scheduled to occur up to 2 weeks following the pre-quit session. Participants will then meet with a smoking cessation counselor for a 15 minute booster counseling session. During the first week following TQD there will be two monitoring visits to closely monitor abstinence. Weekly thereafter for four weeks, participants will attend a brief booster counseling session.

Timeline

• Start date: 2016-05-01
• Primary completion: 2023-06-01
• Completion: 2024-06-01
• First posted: 2016-07-19
• Last updated: 2025-03-05
• Results posted: 2025-03-05

Locations

1 site across 1 country: United States