- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05490251
Translational Research Center in Lung Cancer Disparities (TRACER) Project 2 (TRACER)
May 29, 2026 updated by: Virginia Commonwealth University
Biological Pathways in Stress Reactivity and Nicotine Addiction Among African American and White Smokers
The purpose of this study is to examine racial differences in smoking behaviors and stress responses between African American and white male smokers.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
95
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Angeles, California, United States, 90089
- University of Southern California
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Examining racial differences in acute stress responses
Time Frame: 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)
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Within 1 month following baseline
|
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Examining changes in daily cortisol patterns according to race
Time Frame: Baseline, 4- and 8 weeks post Trier Social Stress Test laboratory visit
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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
|
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Examine changes in stress responses and smoking behaviors as it relates to social determinant factors
Time Frame: 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
|
Baseline, 4- and 8-weeks post Trier Social Stress Test laboratory visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Vanessa Sheppard, PhD, Virginia Commonwealth University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 31, 2024
Primary Completion (Actual)
August 31, 2025
Study Completion (Actual)
August 31, 2025
Study Registration Dates
First Submitted
May 5, 2022
First Submitted That Met QC Criteria
August 3, 2022
First Posted (Actual)
August 5, 2022
Study Record Updates
Last Update Posted (Actual)
June 3, 2026
Last Update Submitted That Met QC Criteria
May 29, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCC-21-18891
- 00116801 (Other Identifier: Medical University of South Carolina)
- HM20022956 (Other Identifier: Virginia Commonwealth University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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