Examining Brain Responses Linked to Emotion in Individuals Who Smoke Cigarettes

Smoking, Tobacco Clinical Trial

Official title:

Examining Brain Responses Linked to Emotion in Individuals Who Smoke Cigarettes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04310735
• Other study ID #: STUDY00011266
• Secondary ID: R21DA045853
• Status: Completed
• Phase: N/A
• Start date: October 4, 2019
• Est. completion date: November 28, 2023

Study information

• Verified date: February 2024
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: November 28, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Smoking, Tobacco

Intervention

Behavioral:
• Verbal smoking expectancy manipulation
Instructions regarding whether or not participants will have an opportunity to smoke during the experimental session.

Locations

Country	Name	City	State
United States	The Pennsylvania State University	University Park	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Penn State University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood-oxygen-level dependent (BOLD) signal	Blood-oxygen-level dependent (BOLD) signal measured using functional magnetic resonance imaging will be compared between groups (participants assigned to the Expect-Yes and Expect-No experimental conditions).	Approximately Day 7 (Visit 2)
Primary	Affect	Subjective affective responses will be measured by using the Facial Action Coding System to code the presence and intensity of facial movements reflecting emotional expression.	Approximately Day 7 (Visit 2)
Secondary	Desire to smoke	Self-report measures of the desire to smoke on a Visual Analog Scale ranging from 0 to 100, with higher scores indicating greater desire to smoke.	Approximately Day 7 (Visit 2)
Secondary	Reported affect	Self-report measures of current affect on a Visual Analog Scale ranging from 0 to 100, with higher scores indicating greater positive affect.	Approximately Day 7 (Visit 2)
Secondary	Nicotine dependence	Total score on the Fagerström Test for Nicotine Dependence, which measures level of nicotine dependence, will be evaluated as a moderator of primary endpoints. Scores on the Fagerström Test for Nicotine Dependence range from 0 to 10, with higher scores indicating greater nicotine dependence.	Day 1 (Visit 1)