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

Sponsor

University of Pennsylvania (Other)

Overall Status

Completed

CT.gov ID

NCT03254433

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arms

25.1

Actual Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Smoking Cessation Weight Loss	Behavioral: BAS+ Behavioral: SC	N/A

Detailed 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

Study Type:

Interventional

Actual Enrollment :

59 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants are randomized to one of two counseling conditions (BAS+ or SC) as part of the main (parent) study.Participants are randomized to one of two counseling conditions (BAS+ or SC) as part of the main (parent) study.

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Aug 9, 2017

Actual Primary Completion Date :

Jun 3, 2019

Actual Study Completion Date :

Sep 12, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BAS+ As part of the main study, participants will attend 8 counseling sessions and receive a behavioral activation intervention to smoking cessation and to post-cessation weight gain (BAS+).	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.
Placebo Comparator: SC As part of the main study, participants will attend 8 counseling sessions and receive standard smoking cessation counseling (SC).	Behavioral: 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.

Arm

Intervention/Treatment

Experimental: BAS+

As part of the main study, participants will attend 8 counseling sessions and receive a behavioral activation intervention to smoking cessation and to post-cessation weight gain (BAS+).

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.

Placebo Comparator: SC

As part of the main study, participants will attend 8 counseling sessions and receive standard smoking cessation counseling (SC).

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

Seven-day point prevalence abstinence at 12 weeks post target quit date [12-Week Follow-Up Visit]
Smoking abstinence will be 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) will be biochemically verified by a carbon monoxide (CO) reading < 8 parts per million and by saliva cotinine < 15ng/ml.
Change from baseline food intake (kcals/day) at 12 weeks post target quit date [Baseline,12-Week Follow-Up]
Food intake will be 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 will use 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).

Secondary Outcome Measures

Change from pre-treatment BOLD signal at end of treatment [Pre-Treatment fMRI Scan (~week -2), End of Treatment fMRI Scan (~week 8)]
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 will be 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.