SmokingTRACERNCT05490251
Translational Research Center in Lung Cancer Disparities (TRACER) Project 2
An observational study of Smoking and Smoking Behaviors, run by Virginia Commonwealth University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Smoking, Smoking Behaviors, Smoking Cessation
- How many people
- 95 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Jan 2024to 31 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- African American and white males
- Between the ages of 18-75 years old
- Smoke at least 5 to 10 cigarettes per day
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Southern California
Los Angeles, California, 90089
About this study
Official title: 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.
Read the 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
- Conditions
- Smoking, Smoking Behaviors, Smoking Cessation, Stress Reaction
- Medical subject headings
- Smoking, Smoking Cessation, Fractures, Stress
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
Measured: Baseline, 4- and 8-weeks post Trier Social Stress Test laboratory visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start31 Jan 2024
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- City of Hope Medical Center, Medical University of South Carolina, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Vanessa Sheppard, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05490251
- Sponsor's protocol ID
- MCC-21-18891
- Other IDs
- 00116801, HM20022956
- Acronym
- TRACER
- Status last verified
- May 2026
- First submitted
- 5 May 2022
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Pathways in Stress Reactivity and Nicotine Addiction Among African American and White Smokers
- ClinicalTrials.gov ID
- NCT05490251
- Acronym / sponsor ID
- TRACER / MCC-21-18891
- Conditions
- Smoking, Smoking Behaviors, Smoking Cessation, Stress Reaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- City of Hope Medical Center, Medical University of South Carolina, National Cancer Institute (NCI)
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 5 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- African American and white males
- Between the ages of 18-75 years old
- Smoke at least 5 to 10 cigarettes per day
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Examining changes in daily cortisol patterns according to race
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vanessa Sheppard, PhD principal investigator
Virginia Commonwealth University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking and Smoking Behaviors, run by Virginia Commonwealth University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Examining racial differences in acute stress responses (time frame: Within 1 month following baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.