Examining Brain Responses Linked to Emotion in Individuals Who Smoke Cigarettes

The Pennsylvania State University (PENNSTATE)

Status: Completed

Conditions: Smoking, Tobacco

Treatments: Behavioral: Verbal smoking expectancy manipulation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04310735

STUDY00011266

R21DA045853 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Experimental: Expect-Yes

Experimental group

Description:

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.

Treatment:

Behavioral: Verbal smoking expectancy manipulation

Experimental: Expect-No

Experimental group

Description:

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.

Treatment:

Behavioral: Verbal smoking expectancy manipulation