Translational Research Center in Lung Cancer Disparities (TRACER) Project 2

Recruiting

• Conditions: Smoking; Smoking Behaviors; Smoking Cessation; Stress Reaction

• Registration Number: NCT05490251
• Lead Sponsor: Virginia Commonwealth University

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

Study Timeline

• Study First Submitted: 2022-05-05
• Study First Submitted QC: 2022-08-03
• Study First Posted: 2022-08-05
• Study Start: 2024-01-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-21
• Primary Completion: 2030-02-28
• Study Completion: 2030-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Examining changes in daily cortisol patterns according to race	Baseline, 4- and 8 weeks post Trier Social Stress Test laboratory visit	Examine racial differences in daily diurnal cortisol slopes to evaluate hypothalamic-pituitary-adrenal-axis dysregulation and acute stress
Examining racial differences in acute stress responses	Within 1 month following baseline	Examine racial differences in acute stress responses using a validated psychological stress challenge called the Trier Social Stress Test (TSST)
Examine changes in stress responses and smoking behaviors as it relates to social determinant factors	Baseline, 4- and 8-weeks post Trier Social Stress Test laboratory visit	Patients will be administered a survey using validated measures to examine socioeconomic, structural, and psychosocial stressors that impact daily stress and smoking behaviors

Trial Locations

Locations (2)

University of Southern California; 🇺🇸 Los Angeles, California, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States