Examining Brain Responses Linked to Emotion in Individuals Who Smoke Cigarettes

NCT ID: NCT04310735

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-04
• Study Completion Date: 2023-11-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Verbal smoking expectancy manipulation

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

Verbal smoking expectancy manipulation

Intervention Type: BEHAVIORAL

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

Interventions

Verbal smoking expectancy manipulation

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Penn State University

OTHER

Sponsor Role: lead

Responsible Party

Stephen Wilson

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Pennsylvania State University

University Park, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R21DA045853

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00011266

Identifier Type: -

Identifier Source: org_study_id