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

Primary Purpose

Smoking Cessation, Weight Loss

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

BAS+

About this trial

This is an interventional other trial for Smoking Cessation focused on measuring Neuroimaging, Smoking Cessation, Weight Loss

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BAS+

Arm Description

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+).

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

Outcomes

Primary Outcome Measures

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.

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).

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03254433

First Posted

August 11, 2017

Last Updated

February 24, 2023

Sponsor

University of Pennsylvania

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT03254433

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

August 9, 2017 (Actual)

Primary Completion Date

June 3, 2019 (Actual)

Study Completion Date

September 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Pennsylvania

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Smoking Cessation, Weight Loss

Keywords

Neuroimaging, Smoking Cessation, Weight Loss

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

Participant

Allocation

Randomized

Enrollment

59 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BAS+

Arm Type

Experimental

Arm Description

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+).

Arm Title

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

BAS+

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Seven-day Point Prevalence Abstinence (Carbon Monoxide) at 12 Weeks Post Target Quit Date

Description

Time Frame

12-Week Follow-Up Visit

Title

Change From Baseline Food Intake (Kcals/Day) at 12 Weeks Post Target Quit Date

Description

Time Frame

Baseline,12-Week Follow-Up

Secondary Outcome Measure Information:

Title

Change From Pre-treatment fMRI BOLD Signal at End of Treatment

Description

Time Frame

Pre-Treatment fMRI Scan (~week -2), End of Treatment fMRI Scan (~week 8)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janet Audrain-McGovern, Ph.D.

Organizational Affiliation

Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania

Official's Role

Principal Investigator

Facility Information:

Facility Name

Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

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

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