Status:
COMPLETED
Tobacco Constituents and Biomarkers
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Smoking
Eligibility:
All Genders
18-65 years
Brief Summary
This proposal addresses several research priorities related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products as mandated by the Family Smoking Preventi...
Eligibility Criteria
Inclusion
- Male or female adult smokers 18-65 years of age, who smoke at least 7 cigarettes per day (to assure that biomarker levels are above the limit of quantitation) and do not have plans to quit smoking in the next month;
- Smoked the same brand for \>80% of their cigarettes over the course of at least 1 year, and smoked not more than 20 cigarettes (1 pack) of a different brand within two weeks prior to the eligibility screening;
- Not using any other nicotine or tobacco product;
- Subjects who are not taking any medications that affect relevant metabolic enzymes;
- Women who are not pregnant or nursing;
- Subjects have provided written informed consent to participate in the study (adolescents under the age of 18 will be excluded because this project involves use of tobacco products).
Exclusion
- Significant immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data;
- Current or recent alcohol or drug abuse problems (to ensure alcohol and drug use does not affect biomarkers of exposure and to maximize retention);
- Regular tobacco use (e.g., greater than weekly) other than cigarettes;
- Currently using nicotine replacement or other tobacco cessation products (to minimize confounding effects of another product);
- Pregnant or breastfeeding (due to toxic effects from tobacco products)
- Report smoking more than 1 pack (20 cigarettes) of a non-usual brand cigarette in the past two weeks \* Participants who report smoking 2 or more non-usual brand cigarettes the day before the clinic visit will be ineligible
Key Trial Info
Start Date :
December 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 22 2021
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT04090606
Start Date
December 1 2013
End Date
March 22 2021
Last Update
August 11 2021
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