Clinical trial NCT04310735: Examining Brain Responses Linked to Emotion in Individuals Who Smoke Cigarettes
Official title: Examining Brain Responses Linked to Emotion in Individuals Who Smoke Cigarettes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking, Tobacco
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2020-03-17
Enrollment: 62
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Brain Activation During Smoking-related and Neutral Cues
timeFrame: Approximately Day 7 (Visit 2)
measure: Coded Facial Expressions Linked to Affect During Smoking-related and Neutral Cues
timeFrame: Approximately Day 7 (Visit 2)
Secondary outcomes:
measure: Self-reported Urge to Smoke During Smoking-related and Neutral Cues
timeFrame: Approximately Day 7 (Visit 2)
measure: Self-reported Affect During Smoking-related and Neutral Cues
timeFrame: Approximately Day 7 (Visit 2)
measure: Nicotine Dependence
timeFrame: Day 1 (Visit 1)
measure: Brain Activation During Positive and Negative Emotion Cues
timeFrame: Approximately Day 7 (Visit 2)
measure: Coded Facial Expressions Linked to Affect During Positive and Negative Emotion Cues
timeFrame: Approximately Day 7 (Visit 2)
measure: Self-reported Urge to Smoke During Positive and Negative Emotion Cues
timeFrame: Approximately Day 7 (Visit 2)
measure: Self-reported Affect During Positive and Negative Emotion Cues
timeFrame: Approximately Day 7 (Visit 2)
Other outcomes:
Locations:
city: University Park
country: United States
facility: The Pennsylvania State University
state: Pennsylvania
Study officials:
References: