Behavioral Activation for Smoking Cessation & the Prevention of

Status Completed

Clinical Trial Summary

This research study is a sub-study within the Behavioral Activation for Smoking Cessation and the Prevention of Post-Cessation Weight Gain main study (NCT02906787). Participants who are eligible for the main study and meet certain MRI (Magnetic Resonance Imaging) related study criteria (i.e. conditions) may also elect to complete a series of computer tasks inside a standard, closed MRI scanner to examine changes in brain activity associated with the smoking cessation counseling that participants will receive in the main study. In total, participants will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment period.

Clinical Trial Description

This neuroimaging sub-study will examine a sub-set of the main study's (Smoking Cessation and the Prevention of Post-Cessation Weight Gain) randomized clinical trial participants (balanced sample between BAS+ and SC). Participants who meet MRI eligibility and elect to participate in the sub-study will complete two, 1-hour functional magnetic resonance imaging (fMRI) scans while completing computer tasks inside an MRI scanner. fMRI can identify mechanisms underlying behavior change beyond self-report and behavioral measures. The investigators will examine neural responses in three parallel pathways including: cognitive control, food cue reactivity, and food reinforcement. The project's three aims address: 1) identifying putative brain mechanisms underlying BAS+ (vs. SC) treatment for smoking cessation and PCWG; 2) evaluating the relative contribution of treatment-induced changes in task related brain signal (Food Cue Response, Food Reinforcement/Choice) in prediction of post treatment food intake; and 3) testing whether BAS+ (vs. SC) induced change in neural responses to food cues and food reinforcement is a stronger predictor of food intake among smokers with greater cognitive control. The findings will address why BAS+ may be effective in managing PCWG and provide insight into which patients are best supported by this treatment. The investigators will also test whether cognitive control processes moderate the influence of BAS+ treatment on food intake. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03254433
Study type	Interventional
Source	University of Pennsylvania
Contact
Status	Completed
Phase	N/A
Start date	August 9, 2017
Completion date	September 12, 2019

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Behavioral Activation for Smoking Cessation and the Prevention of Post-Cessation Weight Gain (Neuroimaging Supplement)

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms