Neural Basis of Eating Behavior in Abstinent Smokers

Not Applicable

Completed

• Conditions: Nicotine Use Disorder
• Interventions: Other: Practice Quit Attempt

• Registration Number: NCT03438188
• Lead Sponsor: University of Pennsylvania

Brief Summary

The purpose of this research study is to better understand why people gain weight when they quit smoking by examining food intake and changes in brain activity in smokers when they are smoking as usual compared to when they have been deprived of cigarettes (i.e., have not smoked for 4 days) as compared to a non-smoker control group.

Detailed Description

Tobacco use and obesity are the two leading causes of preventable deaths. Because these two behaviors share common brain reward mechanisms, reducing one behavior often leads to increases in the other behavior. Behavioral Economic and Incentive Salience models shed much light on this clinical problem. Smoking cessation produces reward dysregulation that can alter the motivational salience of other reinforcers, particularly food. After stopping smoking, smokers increase between-meal snacking, especially foods high in fat and sugar. Increases in caloric intake occur within days of quitting smoking, and are clinically significant. The investigators have also shown that smoking cessation produces working memory deficits and reduces activity in the brain's cognitive control circuits, making it even more difficult to exert self-control over temptations to eat highly rewarding foods. Thus, smokers have a double challenge: food becomes more salient and reinforcing at a time when their neurocognitive resources are compromised.

Neuroimaging can identify mechanisms underlying behavior change beyond self-report and behavioral measures. The proposed functional magnetic resonance imaging (fMRI) study breaks new ground by integrating concepts and tools from the fields of behavioral economics and cognitive neuroscience to accelerate the study of mechanisms underlying PCWG. The investigators will use a previously validated within-subject crossover neuroimaging study design to examine changes in working memory, food salience (cue-induced craving), and food reinforcement processes in the brain after 4 days of smoking cessation (vs. smoking as usual). A non-smoker control group will provide insight into baseline differences from smokers (abstinent and satiated). Caloric intake, the primary outcome, will be assessed using 24-hr. food recalls during each study period. The investigators will assess three parallel pathways including: working memory, food cue reactivity, and food reinforcement at the neural and behavioral levels.

This study will provide new insights about how the brain can constrain or promote the ability of smokers to prevent post cessation weight gain (PCWG) and lead to new interventions that integrate neural and behavioral framework. Support for our predictions would inform testing of novel approaches to prevent PCWG, such as computerized neurocognitive exercise training to increase DLPFC activity and shift activity away from reward sensitive brain networks.

Study Timeline

• Study First Submitted: 2018-02-09
• Study First Submitted QC: 2018-02-15
• Study First Posted: 2018-02-19
• Study Start: 2018-03-01
• Primary Completion: 2023-04-01
• Study Completion: 2023-08-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-25
• Last Update Posted: 2023-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Smoker Group	Practice Quit Attempt	The smokers group will be scanned on 2 occasions: (1) after a 4 day monitored practice quit attempt (biochemically verified), and (2) after 4 days of smoking as usual (order counterbalanced).

Primary Outcome Measures

Name	Time	Method
Abstinence induced change in task BOLD signal change	BOLD fMRI is collected on days 4 and 32 of protocol	The primary with-in subject outcome measure is change in BOLD signal (abstinence minus smoking) for the Food Cue-Induced Craving primary regions of interest for the BOLD fMRI analysis are insula, caudate, OFC and ACC. For the Relative Reinforcing Value of Food task the primary regions of interest are VS and vmPFC. For the Working Memory N-Back Task the primary regions of interest for the BOLD analysis will be DLPFC and medial/frontal cingulate gyrus.

Secondary Outcome Measures

Name	Time	Method
Abstinence induced change in Food Intake	Food intake is collected on days 1-4 and 29-32 of protocol	Food intake will be assessed via 6 telephone-administered, 24-hour dietary recall. Comparable accuracy can be achieved when administered in-person and over the telephone. Food recalls are widely used, reliable, and valid, assessing kcals/day within 10% of actual dietary intake measured under laboratory observation and by doubly labeled water. Change scores will be calculated for Abstinence minus Smoking condition.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States