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

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03254433
• Other study ID #: 825425-Supplement
• Secondary ID: 3R01CA206058-02S
• Status: Completed
• Phase: N/A
• Start date: August 9, 2017
• Est. completion date: September 12, 2019

Study information

• Verified date: February 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: September 12, 2019
• Est. primary completion date: June 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Eligible to participate in the main study (See NCT02906787)

Exclusion Criteria:

• History of claustrophobia.
• Being left-handed.
• Lifetime history of stroke.
• Having a cochlear implant or wearing bilateral hearing aids.
• History of notable head trauma. Although notable head trauma is typically defined as being knocked unconscious for a period of three minutes or longer, notable head trauma will be evaluated on a case-by-case basis by the appropriate personnel prior to an eligibility decision considering exceptions can be made based on the nature and severity of the trauma.
• History of brain or spinal tumor.
• Pacemakers, certain metallic implants or objects, or presence of metal in the eye as contraindicated for MRI.
• Any circumstances (e.g., exclusionary metal implants, certain dental work, and/or physical impairments) and/or conditions that may interfere with MRI and MRI-related study visit procedures. All potential exclusionary circumstances and/or conditions will be evaluated on a case-by-case basis by the appropriate personnel prior to an eligibility decision.
• History of gunshot wounds. Injuries from BB guns will be evaluated on a case-by-case basis by the appropriate personnel prior to an eligibility decision.
• History of epilepsy and/or recurrent or uncontrolled seizures.
• Weight greater than 250 lbs at Intake Visit or self-reported at phone screen. If a participant weighs less than or equal to 250 lbs at Intake, but presents with a weight greater than 250 lbs at either Scan 1 and/or Scan 2, the participant may be permitted to proceed with the scan as long as the participant's weight does not exceed 300 lbs.
• A positive urine drug screen (UDS) for cocaine, opiates, amphetamines, methamphetamines, phencyclidine (PCP), ecstasy (MDMA), barbiturates, benzodiazepines, methadone, and/or oxycodone at either Scan Visit. Depending on the substance and circumstances, a subject may be deemed ineligible for the main study at the discretion of the Principal Investigator as well.
• A Breath Alcohol Reading greater than 0.010 at either Scan Visit. Depending on the circumstances, the Principal Investigator may permit the participant to remain in the sub-study and reschedule a neuroimaging scan to another day.

Related Conditions & MeSH terms

• Body Weight
• Smoking Cessation
• Weight Gain
• Weight Loss

Intervention

Behavioral:
• BAS+
The goal of the BAS+ is to maintain a level of overall reward after cessation by structuring and enhancing opportunities for reinforcement to: (1) ensure that not smoking is as reinforcing as smoking; and (2) prevent an over-reliance on food as a substitute reinforcer for smoking so that PCWG does not precipitate smoking relapse.
• SC
Overeating and weight gain are common concerns reported during smoking cessation treatment. Per convention, SC will address these concerns through standard recommendations to consume low-calorie snack foods, drink water, eat nutritious meals, and exercise, but will not include skills to shape the use of these suggestions.

Locations

Country	Name	City	State
United States	Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seven-day Point Prevalence Abstinence (Carbon Monoxide) at 12 Weeks Post Target Quit Date	Smoking abstinence was assessed and biochemically verified at the 12-week Follow-Up Visit (12 weeks post target quit date). Seven-day point prevalence abstinence (no smoking, not even a puff, for at least 7 days prior to the assessment) was biochemically verified by a carbon monoxide (CO) reading < 8 parts per million.	12-Week Follow-Up Visit
Primary	Change From Baseline Food Intake (Kcals/Day) at 12 Weeks Post Target Quit Date	Food intake was assessed via 3 telephone-administered, 24-hour dietary recalls during the week after (or near) the Baseline Visit, Mid-Treatment 3 Visit (week 4), End of Treatment Visit (week 8) and the 12-week Follow-Up Visit. A trained member of the research staff used a multi-pass method with an interactive computerized software program, the ASA24® (Automated Self-Administered 24-hour Recall), to determine total kcal/day (outcome variable).	Baseline,12-Week Follow-Up
Secondary	Change From Pre-treatment fMRI BOLD Signal at End of Treatment	T2*-weighted Blood Oxygen-Level-Dependent (BOLD) images will be acquired using a wholebrain, single-shot gradient-echo (GE) echo-planar imaging (EPI) sequence. BOLD images were captured (and subsequently analyzed) while participants complete a Food Cue-Induced Craving, Relative Reinforcing Value of Food, and Working Memory task inside the MRI Scanner.	Pre-Treatment fMRI Scan (~week -2), End of Treatment fMRI Scan (~week 8)