Tobacco Constituents and Biomarkers
10. august 2021 opdateret af: Masonic Cancer Center, University of Minnesota
Constituent Yields and Biomarkers of Exposure for Tobacco Product Regulation
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 Prevention and Tobacco Control Act.
Scientific evidence supports the important role of tobacco and cigarette smoke carcinogens in the development of cancers associated with cigarette smoking.
Regulation of the levels of harmful constituents in cigarette smoke is one of the tobacco control strategies that now can be employed by the FDA and may serve to reduce tobacco carcinogen exposures in those smokers who are unable or unwilling to quit smoking.
Such regulation will require a valid and robust approach to the assessment of comparative toxicity and carcinogenicity among various cigarette brands.
This proposal will help develop a testing approach that can produce meaningful predictions of changes in human exposure due to changes in constituent levels in cigarette smoke, and hence serve as a reliable measure for product regulation.
Thus, the proposed research will generate findings and data that are directly relevant to inform the FDA's regulation of the manufacture, distribution, and marketing of tobacco products to protect public health.
The human trial deals with Aims 2 and 3 of this study.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
65
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Adult smokers from Minneapolis-St.
Paul metro area
Beskrivelse
Inclusion Criteria:
- 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 Criteria:
- 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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
FTC Method
|
cigarettes are smoked by drawing 35 mL puff volumes over 2 s, with 60 s interval between puffs and no blocking of filter ventilation holes
|
|
Massachusetts Method
|
45-mL puffs drawn over 2 s, with 30 s interval between puffs and 50% blocking of filter ventilation holes
|
|
Health Canada Intense Method
|
55-mL puff volumes of 2-s duration, with 30 s interval between puffs and 100% blocking of filter ventilation holes
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The extent to which differences in smoke yields of NNN and NNK per mg nicotine are predictive of differences in smokers' exposure to these carcinogens (human trial)
Tidsramme: 1 Year
|
Correlation between urinary total NNN and total NNAL (with and without normalization for total nicotine intake) in smokers and the machine-measured yields of NNN and NNK (per mg nicotine and per cigarette) in cigarettes smoked by these individuals.
The relationship will be investigated for the machine-measured yields generated by 3 different smoking regimens.
|
1 Year
|
|
The extent to which NNN and NNK per mg nicotine levels in spent cigarette filters are predictive of differences in smokers' exposure to these carcinogens (human trial)
Tidsramme: 1 Year
|
Correlation, for each smoker, between the TSNA per mg nicotine content in their spent cigarette filters with the levels of total NNN and total NNAL per nicotine equivalents in their urine
|
1 Year
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Individual factors affecting TSNA per mg nicotine and exposures in smokers (human trial)
Tidsramme: 1 Year
|
Correlation (if any) of individual factors and the relationship between the machine-measured TSNA per mg nicotine and exposures in smokers.
|
1 Year
|
|
Relationship between 1-HOP and TSNA per mg Nicotine
Tidsramme: 1 Year
|
Correlation between urinary biomarker of polycyclic aromatic hydrocarbon exposure (1-HOP) and TSNA per mg nicotine yields in cigarette smoke.
|
1 Year
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. december 2013
Primær færdiggørelse (Faktiske)
22. marts 2021
Studieafslutning (Faktiske)
22. marts 2021
Datoer for studieregistrering
Først indsendt
10. september 2019
Først indsendt, der opfyldte QC-kriterier
12. september 2019
Først opslået (Faktiske)
16. september 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
11. august 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. august 2021
Sidst verificeret
1. august 2021
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2013NTLS115
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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