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

Smoking Cessation Clinical Trial

— TRACER  

Official title:

Biological Pathways in Stress Reactivity and Nicotine Addiction Among African American and White Smokers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05490251
• Other study ID #: MCC-21-18891
• Secondary ID: 00116801HM200229
• Status: Recruiting
• Start date: June 1, 2024
• Est. completion date: February 28, 2030

Study information

• Verified date: April 2024
• Source: Virginia Commonwealth University
• Contact: Kendra Rowe
• Phone: 804-628-4916
• Email: rowek2[@]vcu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 28, 2030
• Est. primary completion date: February 28, 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Stress
• Smoking
• Smoking Behaviors
• Smoking Cessation
• Stress Reaction

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Southern California	Los Angeles	California
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (4)

Lead Sponsor	Collaborator
Virginia Commonwealth University	City of Hope Medical Center, Medical University of South Carolina, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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