Clinical trial NCT05490251: Translational Research Center in Lung Cancer Disparities (TRACER) Project 2
Official title: Biological Pathways in Stress Reactivity and Nicotine Addiction Among African American and White Smokers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Smoking
Smoking Behaviors
Smoking Cessation
Stress Reaction
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: City of Hope Medical Center
name: Medical University of South Carolina
name: National Cancer Institute (NCI)
First posted: 2022-08-05
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: African American and white male daily smokers who are between the ages of 18-75 and who smoke at least 5 to 10 cigarettes per day.

Brief summary: The purpose of this study is to examine racial differences in smoking behaviors and stress responses between African American and white male smokers.

Detailed description: Cigarette smoking is a leading cause of morbidity and mortality from lung cancer among adults in the US. Stress relief and smoking cessation is the best preventive strategy for reducing lung cancer risk and addressing racial disparities in outcomes. Despite this, racial differences are found among those that make quit attempts. Stress has been found to be related to smoking initiation, maintenance, and relapse. Yet, differences in stress responses have not been examined between African American and white smokers. Therefore, this study will examine racial differences in stress responses and smoking behaviors between African American and white male smokers

Eligibility criteria: Inclusion Criteria:

* African American and white males
* Between the ages of 18-75 years old
* Smoke at least 5 to 10 cigarettes per day

Exclusion Criteria:

* Smokers who have a serious cognitive disorder
* Have a personal history of lung cancer
* Personal history of usage of illicit drug and alcohol abuse
* Enrollment in a smoking cessation treatment program during the past 6 months
* Current use of a nicotine replacement therapy
* Have any positive responses on the Mini International Neuropsychiatric Interview (MINI) screener

Primary outcomes:
measure: Examining racial differences in acute stress responses
timeFrame: Within 1 month following baseline
measure: Examining changes in daily cortisol patterns according to race
timeFrame: Baseline, 4- and 8 weeks post Trier Social Stress Test laboratory visit
measure: Examine changes in stress responses and smoking behaviors as it relates to social determinant factors
timeFrame: Baseline, 4- and 8-weeks post Trier Social Stress Test laboratory visit
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Virginia Commonwealth University
name: Robert Winn, MD
role: PRINCIPAL_INVESTIGATOR
References: