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

NCT05490251 | Completed

• 3 other identifiers: MCC-21-1889100116801HM20022956
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 2

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.

Conditions

Smoking; Smoking Behaviors; Smoking Cessation; Stress Reaction

Outcome Measures

Primary Outcomes (3)

• Examining racial differences in acute stress responses

  Examine racial differences in acute stress responses using a validated psychological stress challenge called the Trier Social Stress Test (TSST)

  Within 1 month following baseline

• Examining changes in daily cortisol patterns according to race

  Examine racial differences in daily diurnal cortisol slopes to evaluate hypothalamic-pituitary-adrenal-axis dysregulation and acute stress

  Baseline, 4- and 8 weeks post Trier Social Stress Test laboratory visit

• Examine changes in stress responses and smoking behaviors as it relates to social determinant factors

  Patients will be administered a survey using validated measures to examine socioeconomic, structural, and psychosocial stressors that impact daily stress and smoking behaviors

  Baseline, 4- and 8-weeks post Trier Social Stress Test laboratory visit

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• City of Hope Medical Center: collaborator
• Medical University of South Carolina: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (2)

University of Southern California

Los Angeles, California, 90089, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva will be conducted for analyzing biomarkers of stress (i.e. cortisol, alpha-amylase), and biomarkers related to smoking (i.e. cotinine) Urine will be collected to determine the presence of illicit substances as an indicator of exclusion/inclusion into the study. Patients that provide consent will have additional saliva and urine collected and stored in a centralized biorepository for future research

MeSH Terms

Conditions

Smoking; Smoking Cessation; Fractures, Stress

Condition Hierarchy (Ancestors)

Behavior; Health Behavior; Fractures, Bone; Wounds and Injuries

Study Officials

• Robert Winn, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: August 5, 2022
• Study Start: January 31, 2024
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-12

Locations

US (2)