Neural Basis of Eating Behavior in Abstinent Smokers

NCT03438188 | Completed Results

• 1 other identifier: 828958
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to better understand why people gain weight when they quit smoking by examining food intake and changes in brain activity in smokers when they are smoking as usual compared to when they have been deprived of cigarettes (i.e., have not smoked for 4 days) as compared to a non-smoker control group.

Conditions

Nicotine Use Disorder

Keywords

Nicotine Addiction; Quitting Smoking

Outcome Measures

Primary Outcomes (1)

• Abstinence Induced Change in Task BOLD Signal Change

  The primary outcome measure is change in BOLD signal for the Food Cue-Induced Craving primary regions of interest for the BOLD fMRI analysis are anterior cingulate gyrus (ACC), Insula, Ventral Striatum (VS), and orbital frontal cortex (OFC). For the Working Memory N-Back Task the primary regions of interest for the BOLD analysis will be dorsal lateral prefrontal cortex (DLPFC) and posterior cingulate gyrus (PCC).

  BOLD fMRI is collected on days 4 and 32 of protocol

Study Arms (2)

Smoker Group

EXPERIMENTAL

The smokers group will be scanned on 2 occasions: (1) after a 4 day monitored practice quit attempt (biochemically verified), and (2) after 4 days of smoking as usual (order counterbalanced).

Other: Practice Quit Attempt

Non-Smoking Comparison Group

NO INTERVENTION

Healthy non-smokers will complete one period (comparable to abstinence arm) of the study to serve as a baseline comparison group.

Interventions

Practice Quit Attempt OTHER

Smokers will be studied under 2 conditions: smoking as usual and during a 4 day practice quit attempt.

Smoker Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female participants who are between 18 and 45 years of age.
• Smoking group - 80 treatment-seeking smokers who self-report smoking at least 10 cigarettes (menthol and/or non-menthol) per day for at least the last 6 months. Smoking status will be confirmed by CO greater than or equal to 8 parts per million (ppm) at the Intake Visit.
• Non-smoking group - 30 individuals reporting fewer than 100 lifetime cigarettes and not even a puff of a cigarette for a minimum of 2 years. Smoking status of non-smokers will be confirmed by CO less than 5ppm. They will be matched to the smoker group on age, sex, and education.
• Plan to live in the area for the duration of the study (i.e. \~8 weeks/2 months).
• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form.
• Smokers who wish to make a permanent quit attempt in the next 1-2 months (treatment-seeking), because our prior work suggests that motivated subjects are more sensitive to medication effects on smoking behavior. Using a scale from 0 to 100 (100, being extremely interested), subjects must rate their interest in quitting smoking within the next 1-2 months greater than 50.
• Able to communicate fluently in English (i.e. speaking, writing, and reading).

You may not qualify if:

• Subjects who present and/or self-report with the following criteria will not be eligible to participate in the study:
• Smoking Behavior
• Regular use of nicotine-containing products other than cigarettes (e.g. chewing tobacco, snuff, snus, cigars, e-cigs, etc.). Participants agreeing to abstain from using nicotine- containing products other than cigarettes will be considered eligible.
• Current enrollment or plans to enroll in another research and/or smoking cessation program over the duration of the study (i.e. \~8 weeks/2 months).
• Anticipated use (within the next \~8 weeks/2 months) of any nicotine substitutes and/or smoking cessation treatments/medications unless provided through the study.
• Provide a CO breath test reading less than 8 ppm at Intake Visit (smokers) or greater than 5ppm at intake visit (non-smokers).
• Alcohol and Drug
• History of substance abuse (other than nicotine) in the past 12 months and/or currently receiving medical treatment for substance abuse. Counseling and support groups (e.g. Alcoholics Anonymous and Narcotics Anonymous) will not be considered medical treatment for the purposes of this protocol.
• Current alcohol consumption that exceeds 25 standard drinks/week.
• Breath alcohol reading (BrAC) greater than .000 at the Intake Visit.
• A positive urine drug screen (UDS) for cocaine, opiates, amphetamines, methamphetamines, phencyclidine (PCP), ecstasy (MDMA), barbiturates, benzodiazepines, methadone, and/or oxycodone at the Intake Visit.
• Medical
• Women who are pregnant, breast feeding, or planning a pregnancy over the duration of the study period. Women must agree to use an adequate form of contraception or abstain from sexual intercourse for the duration of the study.
• Current treatment of cancer or diagnosed with cancer (except basal or squamous-cell carcinoma not treated with chemotherapy and/or radiation) in the past 6 months.
• Poorly controlled, brittle, or pump-dependent Type I diabetes.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking Cessation

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior

Results Point of Contact

• Title: James Loughead, Ph.D.
• Organization: Perlman School of Medicine, University of Pennsylvania

loughead@pennmedicine.upenn.edu

215-205-1876

Study Officials

• James Loughead

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Smoking participants will be studding under both smoking as usual and abstinent conditions (crossover) and non-smokers only under "abstinence."
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a within-subject cross-over neuroimaging investigation of 3 potential neural mechanisms of increased caloric intake during initial smoking cessation. Eighty smokers will be scanned on 2 occasions: (1) after 4 days of monitored abstinence (biochemically verified), and (2) after 4 days of smoking as usual (order counterbalanced). In addition, 30 healthy non-smokers (matched for sex, age, and education) will complete one period of the study to serve as a baseline comparison group.

Study Record Dates

• First Submitted: February 9, 2018
• First Posted: February 19, 2018
• Study Start: March 1, 2018
• Primary Completion: April 1, 2023
• Study Completion: August 30, 2023
• Last Updated: February 5, 2025
• Results First Posted: February 5, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)