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SmokingNCT05572671

Linking Brain Network Dynamics to Imminent Smoking Lapse Risk and Behavior

A study testing Laboratory task modeling smoking lapse behavior in people with Smoking and Tobacco Use, run by Penn State University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Smoking, Tobacco Use
What is being tested?
Laboratory task modeling smoking lapse behavior
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteUnited States
Study dates
4 Apr 2023to Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • The Pennsylvania State University

    University Park, Pennsylvania, 16870

    Stephen Wilson, 8144047628, sjw42@psu.edu

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

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. This novel fMRI paradigm includes an in-scanner delay period that models the ability to resist smoking during acute nicotine abstinence and a post-scan ad-lib period that captures key aspects of the smoking behavior that follows. Adults who smoke will abstain from cigarettes for 12 hours before completing the fMRI lapse paradigm. 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. The study will focus specifically on linking lapse-related outcomes to time-dependent interactions between two large-scale brain networks: the executive control network, which includes parts of the lateral prefrontal and parietal cortices, and the default mode network, which includes parts of the medial prefrontal and posterior cingulate cortices. The central hypothesis guiding the proposed research is that lapse-related behavior and affect will be predicted by the extent to which the default mode network and the executive control network are functionally segregated (i.e., the strength of the connectivity within the default mode and executive control networks, relative to connectivity between the networks). The aims of the project are: 1) To examine the association between time-dependent changes in brain network dynamics and subsequent risk of smoking lapse; 2) To examine the association between time-dependent changes in brain network dynamics and self-reported affect leading up to a smoking lapse; and 3) To examine the association between brain network dynamics directly before a lapse and reinforcement from the smoking that follows. An additional exploratory aim of the study is to evaluate potential moderators of the association between brain network dynamics and lapse-related outcomes.

Conditions
Smoking, Tobacco Use
Being tested
Laboratory task modeling smoking lapse behavior
Medical subject headings
Smoking, Tobacco Use

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laboratory task modeling smoking lapse behaviorBehavioural

    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 groups in NCT05572671
Study groupRoleWhat they receive
fMRI smoking lapse taskExperimentalNot described
Receives: Behavioral: Laboratory task modeling smoking lapse behavior

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood-oxygen-level dependent (BOLD) signal

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

    Measured: Day 2 (Visit 2)

  2. Self-reported affect

    Self-report ratings of affective valence and arousal

    Measured: Day 2 (Visit 2)

Secondary outcomes (1)
  1. Self-reported craving and nicotine withdrawal symptoms

    Self-report ratings of level of craving and other common nicotine withdrawal symptoms (e.g., irritability)

    Measured: Day 2 (Visit 2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2022
  2. Study start4 Apr 2023
  3. Primary completionJul 2027 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05572671
Sponsor's protocol ID
STUDY00020857
Status last verified
Mar 2026
First submitted
5 Oct 2022
Last updated
5 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Laboratory task modeling smoking lapse behavior in people with Smoking and Tobacco Use, run by Penn State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood-oxygen-level dependent (BOLD) signal (time frame: Day 2 (Visit 2)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026; AzTrials last refreshed its copy on 2 Nov 2026.

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