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Clinical Trials/NCT04310735
NCT04310735CompletedNot Applicable

Examining Brain Responses Linked to Emotion in Individuals Who Smoke Cigarettes

Penn State University2 sites in 1 country62 target enrollmentStarted: October 4, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
62
Locations
2
Primary Endpoint
Brain Activation During Smoking-related and Neutral Cues

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
21 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Participants must be between the ages of 21 and
  • 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.

Arms & Interventions

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.

Intervention: Verbal smoking expectancy manipulation (Behavioral)

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.

Intervention: Verbal smoking expectancy manipulation (Behavioral)

Outcomes

Primary Outcomes

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,

Secondary Outcomes

  • 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))
  • Self-reported Affect 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))
  • Self-reported Urge to Smoke During Positive and Negative Emotion Cues(Approximately Day 7 (Visit 2))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Stephen Wilson

Associate Professor

Penn State University

Study Sites (2)

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