Examining Brain Responses Linked to Emotion in Individuals Who Smoke Cigarettes

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.

Study Overview

• Status: Completed
• Conditions: Smoking, Tobacco
• Intervention / Treatment: Behavioral: Verbal smoking expectancy manipulation

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • University Park, Pennsylvania, United States, 16870
      • The Pennsylvania State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Expect-Yes; 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.	Behavioral: Verbal smoking expectancy manipulation; Instructions regarding whether or not participants will have an opportunity to smoke during the experimental session.
Experimental: Experimental: Expect-No; 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.	Behavioral: Verbal smoking expectancy manipulation; Instructions regarding whether or not participants will have an opportunity to smoke during the experimental session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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,	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,	Approximately Day 7 (Visit 2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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,	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.	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.	Approximately Day 7 (Visit 2)

Collaborators and Investigators

• Sponsor: Penn State University
• Collaborators: National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2019
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): November 28, 2023

Study Registration Dates

• First Submitted: March 11, 2020
• First Submitted That Met QC Criteria: March 13, 2020
• First Posted (Actual): March 17, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 4, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00011266; R21DA045853 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No