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



Status:Recruiting
Conditions:Obesity Weight Loss, Obesity Weight Loss, Smoking Cessation
Therapuetic Areas:Endocrinology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 65
Updated:11/4/2018
Start Date:August 9, 2017
End Date:April 2019
Contact:Benjamin F Albelda, B.S.
Email:albeldab@mail.med.upenn.edu
Phone:2157467173

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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.

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.

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.
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