Smoking, TobaccoNCT04310735

Examining Brain Responses Linked to Emotion in Individuals Who Smoke Cigarettes

A study testing Verbal smoking expectancy manipulation in people with Smoking, Tobacco, run by Penn State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Smoking, Tobacco
What is being tested?: Verbal smoking expectancy manipulation
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 62 participants
Where: 1 siteUnited States
Study dates: 4 Oct 2019to 28 Nov 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Participants must be between the ages of 21 and 55.
Participants must be right handed.
Participants must be fluent English speakers.
Participants must report smoking at least 6 cigarettes per day continuously for at least the 12 preceding months.
Participants must have a baseline expired air carbon monoxide (CO) exceeding a cutoff based upon prior research in order to verify smoking status.

Who cannot join

Individuals will be excluded if they report that they are actively trying to quit smoking.
Individuals will be excluded if they report that they have had significant cardiovascular disease (such as heart disease, heart attack, stroke, or angina) or respiratory disease (such as asthma, chronic bronchitis, or COPD) during the past year.
Individuals will be excluded if they report that they have used any of the following illicit substances more than 10 times in the previous 30 days: marijuana, cocaine, opiates such as heroin, methadone, benzodiazepines (such as Valium, Xanax), barbiturates, amphetamines, methamphetamines, PCP, LSD or any other hallucinogen.
Individuals will be excluded if they report that they are currently taking prescription medications that previously have been found to affect blood flow responses in the brain.
Individuals will be excluded if they have any known risk from exposure to high-field strength magnetic fields (e.g., pace makers), 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.
Individuals will be excluded if they meet criteria for current dependence on a substance other than nicotine based upon a brief structured interview.

Show all 10Show fewer

Individuals will be excluded if they report that they are not willing to refrain from using alcohol and recreational drugs for 24 hours and nicotine for 12 hours before the experimental lab visit.
Individuals will be excluded if they currently use nicotine products other than cigarettes (e.g., chewing tobacco, snuff, e-cigarettes, or smoking cessation products).
Individuals will be excluded if they are claustrophobic or are prone to becoming very uncomfortable in confined spaces.
Individuals will be excluded if they report that they exclusively or primarily smoke "roll-your-own" cigarettes.

Trial locations and contacts

1 site in 1 country.

United States1 site

The Pennsylvania State University
University Park, Pennsylvania, 16870

Other trials in United States

About this study

The study will use functional magnetic resonance imaging and facial coding methods to study individuals who smoke cigarettes. Smoking expectancy (the extent to which one perceives an opportunity to smoke a cigarette) will be manipulated using instructions, and the investigators will examine the effects of this manipulation on two primary endpoints under conditions designed to induce an urge to smoke: (1) brain responses measured using fMRI and (2) subjective affective responses measured using facial coding. Secondary endpoints include self-report measures of the desire to smoke and current affect.

Conditions: Smoking, Tobacco
Being tested: Verbal smoking expectancy manipulation
Medical subject headings: Tobacco Smoking

What participants receive

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

Verbal smoking expectancy manipulationBehavioural
Instructions regarding whether or not participants will have an opportunity to smoke during the experimental session.

Study groups in NCT04310735
Study group	Role	What they receive
Experimental: Expect-Yes	Experimental	Participants assigned to this condition will undergo a verbal smoking expectancy manipulation such that they will perceive an opportunity to smoke during the experimental session. Receives: Behavioral: Verbal smoking expectancy manipulation
Experimental: Expect-No	Experimental	Participants assigned to this condition will undergo a verbal smoking expectancy manipulation such that they will not perceive an opportunity to smoke during the experimental session. Receives: Behavioral: Verbal smoking expectancy manipulation

What is being measured

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

Brain Activation During Smoking-related and Neutral Cues
Blood-oxygen-level dependent (BOLD) signal measured using functional magnetic resonance imaging (fMRI) was analyzed as participants were presented with smoking-related and neutral cues. Following preprocessing with fMRIPrep (version 20.2.7), the FMRI Expert Analysis Tool (FEAT) from FMRIB's Software Library (FSL; version 6.0.7.4) was used to characterize brain activation differences in response to smoking-related versus neutral cues. Contrast of parameter estimate (COPE) values were calculated for each participant, and these COPE values were then extracted for two a priori regions of interest (ROIs) to compare activation patterns between the groups. Larger COPE values indicate greater differences in brain activation between smoking-related and neutral cues,
Measured: Approximately Day 7 (Visit 2)
Coded Facial Expressions Linked to Affect During Smoking-related and Neutral Cues
Subjective affective responses were measured by using FaceReader software (version 9.1.7) to code the valence (positive or negative) of facial movements associated with emotional expression during the presentation of smoking-related and neutral cues. Possible values for valence range from -1 to 1, with higher values indicating greater positive affect,
Measured: Approximately Day 7 (Visit 2)

Secondary outcomes (7)

Self-reported Urge to Smoke During Smoking-related and Neutral Cues
Participants rated their urge to smoke during the presentation of smoking-related and neutral cues on a scale ranging from 1 (not at all) to 9 (extremely), with higher scores indicating a stronger desire to smoke. For each type of cue (smoking-related and neutral), repeated ratings were obtained across multiple trials. To report a single value for each Arm/Group, the ratings were averaged across all trials for each cue type.
Measured: Approximately Day 7 (Visit 2)
Self-reported Affect During Smoking-related and Neutral Cues
Participants rated their current affect during the presentation of smoking-related and neutral cues on a scale ranging from 1 (very negative) to 9 (very positive), with higher scores indicating greater positive affect. For each type of cue (smoking-related and neutral), repeated ratings were obtained across multiple trials. To report a single value for each Arm/Group, the ratings were averaged across all trials for each cue type.
Measured: Approximately Day 7 (Visit 2)
Nicotine Dependence
Participants' level of nicotine dependence was assessed using the total score on the Fagerström Test for Nicotine Dependence to help characterize the sample. Possible scores on the Fagerström Test for Nicotine Dependence range from 0 to 10, with higher scores indicating greater nicotine dependence.
Measured: Day 1 (Visit 1)
Brain Activation During Positive and Negative Emotion Cues
Blood-oxygen-level dependent (BOLD) signal measured using functional magnetic resonance imaging (fMRI) was analyzed as participants were presented with cues designed to elicit positive and negative emotion. Following preprocessing with fMRIPrep (version 20.2.7), the FMRI Expert Analysis Tool (FEAT) from FMRIB's Software Library (FSL; version 6.0.7.4) was used to characterize brain activation in response to positive and negative emotion cues. Contrast of parameter estimate (COPE) values were calculated for each participant, and these COPE values were then extracted for two a priori regions of interest (ROIs) to compare activation patterns between the groups. Larger COPE values indicate greater differences in brain activation between positive and negative emotion cues.
Measured: Approximately Day 7 (Visit 2)
Coded Facial Expressions Linked to Affect During Positive and Negative Emotion Cues
Subjective affective responses were measured by using FaceReader software (version 9.1.7) to code the valence (positive or negative) of facial movements associated with emotional expression during the presentation of cues designed to elicit positive and negative emotion. Possible values for valence range from -1 to 1, with higher values indicating greater positive affect,
Measured: Approximately Day 7 (Visit 2)
Self-reported Urge to Smoke During Positive and Negative Emotion Cues
Participants rated their urge to smoke during the presentation of cues designed to elicit positive and negative emotions on a scale ranging from 1 (not at all) to 9 (extremely), with higher scores indicating a stronger desire to smoke. For each type of cue (positive and negative emotion), repeated ratings were obtained across multiple trials. To report a single value for each Arm/Group, the ratings were averaged across all trials for each cue type.
Measured: Approximately Day 7 (Visit 2)
Self-reported Affect During Positive and Negative Emotion Cues
Participants rated their current affect during the presentation of cues designed to elicit positive and negative emotion on a scale ranging from 1 (very negative) to 9 (very positive), with higher scores indicating greater positive affect. For each type of cue (positive and negative emotion), repeated ratings were obtained across multiple trials. To report a single value for each Arm/Group, the ratings were averaged across all trials for each cue type.
Measured: Approximately Day 7 (Visit 2)

Timeline

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

4 Oct 201928 Nov 2023

First posted17 Mar 2020
Study start4 Oct 2019
Primary completion30 Jun 2023
Study completion28 Nov 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Smoking, TobaccoStudies 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 62 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04310735
Sponsor's protocol ID: STUDY00011266
Other IDs: R21DA045853
Status last verified: Mar 2025
First submitted: 11 Mar 2020
Last updated: 7 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: De-identified data and related materials (e.g., scripts) will be made publicly available on the Open Science Framework (OSF) to facilitate replication. Similarly, unthresholded fMRI statistical maps will be made publicly available on NeuroVault.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Examining Brain Responses Linked to Emotion in Individuals Who Smoke Cigarettes
ClinicalTrials.gov ID: NCT04310735
Acronym / sponsor ID: STUDY00011266
Conditions: Smoking, Tobacco
Study type: Interventional
Recruitment status: Completed
Enrolment: 62 participants (actual)
Lead sponsor: Penn State UniversityUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 4 Oct 2019 (actual)
Primary completion: 30 Jun 2023 (actual)
Study completion: 28 Nov 2023 (actual)
First posted: 17 Mar 2020 (actual)
Results: Posted 7 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Experimental: Expect-Yes	Experimental	Behavioral: Verbal smoking expectancy manipulationParticipants assigned to this condition will undergo a verbal smoking expectancy manipulation such that they will perceive an opportunity to smoke during the experimental session.
Experimental: Expect-No	Experimental	Behavioral: Verbal smoking expectancy manipulationParticipants assigned to this condition will undergo a verbal smoking expectancy manipulation such that they will not perceive an opportunity to smoke during the experimental session.

Who may qualify

Ages: 21 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Participants must be between the ages of 21 and 55.
Participants must be right handed.
Participants must be fluent English speakers.
Participants must report smoking at least 6 cigarettes per day continuously for at least the 12 preceding months.
Participants must have a baseline expired air carbon monoxide (CO) exceeding a cutoff based upon prior research in order to verify smoking status.

Key exclusion criteria (10 listed)

Individuals will be excluded if they report that they are actively trying to quit smoking.
Individuals will be excluded if they report that they have had significant cardiovascular disease (such as heart disease, heart attack, stroke, or angina) or respiratory disease (such as asthma, chronic bronchitis, or COPD) during the past year.
Individuals will be excluded if they report that they have used any of the following illicit substances more than 10 times in the previous 30 days: marijuana, cocaine, opiates such as heroin, methadone, benzodiazepines (such as Valium, Xanax), barbiturates, amphetamines, methamphetamines, PCP, LSD or any other hallucinogen.
Individuals will be excluded if they report that they are currently taking prescription medications that previously have been found to affect blood flow responses in the brain.
Individuals will be excluded if they have any known risk from exposure to high-field strength magnetic fields (e.g., pace makers), 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
Verbal smoking expectancy manipulationInstructions regarding whether or not participants will have an opportunity to smoke during the experimental session.	Behavioural	Experimental: Expect-No, Experimental: Expect-Yes

Primary outcome

Brain Activation During Smoking-related and Neutral Cues
Time frame: Approximately Day 7 (Visit 2)
Blood-oxygen-level dependent (BOLD) signal measured using functional magnetic resonance imaging (fMRI) was analyzed as participants were presented with smoking-related and neutral cues. Following preprocessing with fMRIPrep (version 20.2.7), the FMRI Expert Analysis Tool (FEAT) from FMRIB's Software Library (FSL; version 6.0.7.4) was used to characterize brain activation differences in response to smoking-related versus neutral cues. Contrast of parameter estimate (COPE) values were calculated for each participant, and these COPE values were then extracted for two a priori regions of interest (ROIs) to compare activation patterns between the groups. Larger COPE values indicate greater differences in brain activation between smoking-related and neutral cues,
Coded Facial Expressions Linked to Affect During Smoking-related and Neutral Cues
Time frame: Approximately Day 7 (Visit 2)
Subjective affective responses were measured by using FaceReader software (version 9.1.7) to code the valence (positive or negative) of facial movements associated with emotional expression during the presentation of smoking-related and neutral cues. Possible values for valence range from -1 to 1, with higher values indicating greater positive affect,

7 secondary outcomes

Self-reported Urge to Smoke During Smoking-related and Neutral Cues
Time frame: Approximately Day 7 (Visit 2)
Self-reported Affect During Smoking-related and Neutral Cues
Time frame: Approximately Day 7 (Visit 2)
Nicotine Dependence
Time frame: Day 1 (Visit 1)
Brain Activation During Positive and Negative Emotion Cues
Time frame: Approximately Day 7 (Visit 2)
Coded Facial Expressions Linked to Affect During Positive and Negative Emotion Cues
Time frame: Approximately Day 7 (Visit 2)
Self-reported Urge to Smoke During Positive and Negative Emotion Cues
Time frame: Approximately Day 7 (Visit 2)
Self-reported Affect During Positive and Negative Emotion Cues
Time frame: Approximately Day 7 (Visit 2)

Results and safety

Results posted to the registry on 7 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental: Expect-Yes	14	13
Experimental: Expect-No	13	9
Behavioral Testing	35	27

Primary outcome: Brain Activation During Smoking-related and Neutral Cues

Time frame: Approximately Day 7 (Visit 2). Mean (Standard Error). Unit: contrast of parameter estimate

Measure	Experimental: Expect-Yes n = 9	Experimental: Expect-No n = 11
Ventromedial prefrontal cortex ROI (10-mm sphere centered at MNI x = -1, y = 46, z = -7)	5.8 (2.4)	-1.6 (3.8)
Dorsal anterior cingulate cortex ROI (10-mm sphere centered at MNI x = -2, y = 10, z = 38)	1.1 (3.4)	-4.2 (2.8)

Experimental: Expect-Yes vs Experimental: Expect-No: p = 0.13, t-test, 2 sided
Experimental: Expect-Yes vs Experimental: Expect-No: p = .25, t-test, 2 sided

Population analysed: Participants who completed the scan session and who provided usable brain imaging data were included in analyses. Participants in the Behavioral Testing Arm did not complete a scan session and were not assessed for brain activation during smoking-related and neutral cues.

Primary outcome: Coded Facial Expressions Linked to Affect During Smoking-related and Neutral Cues

Time frame: Approximately Day 7 (Visit 2). Mean (Standard Error). Unit: units on a scale

Measure	Experimental: Expect-Yes n = 9	Experimental: Expect-No n = 11	Behavioral Testing n = 9
Valence during smoking-related cues	-.27 (.09)	-.24 (.09)	-.23 (.08)
Valence during neutral cues	-.27 (.10)	-.25 (.09)	-.18 (.08)

Experimental: Expect-Yes vs Experimental: Expect-No: p = .80, t-test, 2 sided
Experimental: Expect-Yes vs Experimental: Expect-No: p = .87, t-test, 2 sided

Population analysed: Participants who provided usable facial expression data were included in analyses.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse data were collected for the duration of each of the two study visits, which were held an average of approximately 12 days apart.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental: Expect-Yes	0 of 14 (0%)	0 of 14 (0%)	0 of 14
Experimental: Expect-No	0 of 13 (0%)	0 of 13 (0%)	0 of 13
Behavioral Testing	0 of 35 (0%)	0 of 35 (0%)	0 of 35

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided. De-identified data and related materials (e.g., scripts) will be made publicly available on the Open Science Framework (OSF) to facilitate replication. Similarly, unthresholded fMRI statistical maps will be made publicly available on NeuroVault.

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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Verbal smoking expectancy manipulation in people with Smoking, Tobacco, 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 10 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: finished, as of the sponsor's last update on 7 Mar 2025. 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?

Yes. Results are posted in the registry (first posted 7 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Brain Activation During Smoking-related and Neutral Cues (time frame: Approximately Day 7 (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?

On the ClinicalTrials.gov record for NCT04310735.

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 7 Mar 2025.