Examining Brain Responses Linked to Emotion in Individuals Who Smoke Cigarettes

NCT04310735 | Completed Results

• 2 other identifiers: STUDY00011266R21DA045853
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Self-reported Urge to Smoke During Smoking-related and Neutral Cues

  Approximately Day 7 (Visit 2)

• Self-reported Affect During Smoking-related and Neutral Cues

  Approximately Day 7 (Visit 2)

• Nicotine Dependence

  Day 1 (Visit 1)

• Brain Activation During Positive and Negative Emotion Cues

  Approximately Day 7 (Visit 2)

• Coded Facial Expressions Linked to Affect During Positive and Negative Emotion Cues

  Approximately Day 7 (Visit 2)

Study Arms (2)

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.

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.

Behavioral: Verbal smoking expectancy manipulation

Interventions

Verbal smoking expectancy manipulation BEHAVIORAL

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

Experimental: Expect-No; Experimental: Expect-Yes

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Penn State University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

The Pennsylvania State University

University Park, Pennsylvania, 16870, United States

Location

MeSH Terms

Conditions

Tobacco Smoking

Condition Hierarchy (Ancestors)

Smoking; Behavior; Tobacco Use

Results Point of Contact

• Title: Stephen Wilson
• Organization: The Pennsylvania State University

sjw42@psu.edu

8148656219

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 11, 2020
• First Posted: March 17, 2020
• Study Start: October 4, 2019
• Primary Completion: June 30, 2023
• Study Completion: November 28, 2023
• Last Updated: March 7, 2025
• Results First Posted: March 7, 2025

Record last verified: 2025-03

Locations

US (1)