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

February 24, 2023 updated by: Janet Audrain-McGovern, University of Pennsylvania
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
59

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Seven-day Point Prevalence Abstinence (Carbon Monoxide) at 12 Weeks Post Target Quit Date
Time Frame: 12-Week Follow-Up Visit
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
Change From Baseline Food Intake (Kcals/Day) at 12 Weeks Post Target Quit Date
Time Frame: Baseline,12-Week Follow-Up
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Pre-treatment fMRI BOLD Signal at End of Treatment
Time Frame: 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 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Janet Audrain-McGovern, Ph.D., Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 9, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 3, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 12, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 11, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 18, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 825425-Supplement
  • 3R01CA206058-02S1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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