Linking Brain Network Dynamics to Imminent Smoking Lapse Risk and Behavior

NCT05572671 | Recruiting

• 1 other identifier: STUDY00020857
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Most attempts to quit smoking end in relapse, or a return to regular smoking. One of the biggest threats to cessation is a lapse (i.e., any cigarette use during a quit attempt). Thus, characterizing why lapses occur is essential to understanding and preventing smoking relapse. Functional magnetic resonance imaging (fMRI) is a promising method for characterizing the psychological processes that lead to smoking lapses because it provides a way to measures patterns of brain activity thought to reflect relevant mental processes as they change over time. However, methodological issues have hindered the ability to capitalize on this potential and prevented an understanding of how brain activity and corresponding psychological processes unfold in the critical moments that immediately precede a smoking lapse. The proposed project will address this knowledge gap using a novel fMRI paradigm adapted from a well-validated behavioral lapse task. The goals of the project are to characterize changes in brain activity that lead up to a lapse and to investigate how these changes are related to concurrent affect and subsequent cigarette use.

Conditions

Smoking; Tobacco Use

Outcome Measures

Primary Outcomes (2)

• Blood-oxygen-level dependent (BOLD) signal

  Blood-oxygen-level dependent (BOLD) signal measured using functional magnetic resonance imaging

  Day 2 (Visit 2)

• Self-reported affect

  Self-report ratings of affective valence and arousal

  Day 2 (Visit 2)

Secondary Outcomes (1)

• Self-reported craving and nicotine withdrawal symptoms

  Day 2 (Visit 2)

Study Arms (1)

fMRI smoking lapse task

EXPERIMENTAL

Behavioral: Laboratory task modeling smoking lapse behavior

Interventions

Laboratory task modeling smoking lapse behavior BEHAVIORAL

Participants will complete a task (the behavioral intervention) designed to model smoking lapse behavior in the laboratory; during the task, they will be given the option of delaying smoking in exchange for monetary reinforcement.

fMRI smoking lapse task

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be between the ages of 21 and 65.
• Participants must be fluent English speakers.
• Participants must pass an MRI safety screening.
• Participants must report smoking at least six cigarettes per day continuously for at least the 12 preceding months.
• Participants must have a baseline expired-air carbon monoxide exceeding 10 parts per million in order to verify smoking status.

You may not qualify if:

• Individuals will be excluded if they report that they are not willing to refrain from using nicotine for 12 hours before the experimental lab visit.
• Individuals will be excluded if they have any known risk from exposure to high-field strength magnetic fields (e.g., pacemakers), any irremovable metallic foreign objects in their body (e.g., braces), or a questionable history of metallic fragments that are likely to create artifact on the MRI scans.

Sponsors & Collaborators

• Penn State University: lead

Study Sites (1)

The Pennsylvania State University

University Park, Pennsylvania, 16870, United States

RECRUITING

MeSH Terms

Conditions

Smoking; Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychology

Model Details: Participants will complete a task (the behavioral intervention) designed to model smoking lapse behavior in the laboratory; during the task, they will be given the option of delaying smoking in exchange for monetary reinforcement.

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 10, 2022
• Study Start: April 4, 2023
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-03

Locations

US (1)