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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
- Recruiting
The Pennsylvania State University
University Park, Pennsylvania, 16870
Stephen Wilson, 8144047628, sjw42@psu.edu
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 group | Role | What they receive |
|---|---|---|
| fMRI smoking lapse task | Experimental | Not 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.
Blood-oxygen-level dependent (BOLD) signal
Blood-oxygen-level dependent (BOLD) signal measured using functional magnetic resonance imaging
Measured: Day 2 (Visit 2)
Self-reported affect
Self-report ratings of affective valence and arousal
Measured: Day 2 (Visit 2)
Secondary outcomes (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.
- First posted10 Oct 2022
- Study start4 Apr 2023
- Primary completionJul 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Wilson, Penn State University
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
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linking Brain Network Dynamics to Imminent Smoking Lapse Risk and Behavior
- ClinicalTrials.gov ID
- NCT05572671
- Acronym / sponsor ID
- STUDY00020857
- Conditions
- Smoking, Tobacco Use
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 4 Apr 2023 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| fMRI smoking lapse task | Experimental | Behavioral: Laboratory task modeling smoking lapse behavior |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory task modeling smoking lapse behaviorParticipants 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. | Behavioural | fMRI smoking lapse task |
Primary outcome
Blood-oxygen-level dependent (BOLD) signal
Time frame: Day 2 (Visit 2)
Blood-oxygen-level dependent (BOLD) signal measured using functional magnetic resonance imaging
Self-reported affect
Time frame: Day 2 (Visit 2)
Self-report ratings of affective valence and arousal
1 secondary outcome
Self-reported craving and nicotine withdrawal symptoms
Time frame: Day 2 (Visit 2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.