Urinary Cotinine and Cotinine + Trans-3′-Hydroxycotinine (TNE-2) Cut-points for Distinguishing Tobacco Use from Nonuse in the United States: PATH Study (2013–2014): PATH study (2013-2014)

Kathryn C. Edwards, Tasmia Naz, Cassandra A. Stanton, Maciej L. Goniewicz, Dorothy K. Hatsukami, Danielle M. Smith, Lanqing Wang, Andrea Villanti, Jennifer Pearson, Benjamin C. Blount, Maansi Bansal-Travers, June Feng, Raymond Niaura, Michelle T. Bover Manderski, Connie S. Sosnoff, Cristine D. Delnevo, Kara Duffy, Arseima Y. Del Valle-Pinero, Brian L. Rostron, Colm EverardHeather L. Kimmel, Dana M. van Bemmel, Andrew Hyland

Research output: Contribution to journalArticlepeer-review

9 Scopus citations


Background: Determine the overall, sex-, and racially/ethnically-appropriate population-level cotinine and total nicotine equivalents (TNE-2, the molar sum of the two major nicotine metabolites) cut-points to distinguish tobacco users from nonusers across multiple definitions of use (e.g., exclusive vs. polytobacco, and daily vs. non-daily). Methods: Using Wave 1 (2013-2014) of the U.S. Population Assessment of Tobacco and Health (PATH) Study, we conducted weighted Receiver Operating Characteristic (ROC) analysis to determine the optimal urinary cotinine and TNE-2 cut-points, stratified by sex and race/ethnicity. Results: For past 30-day exclusive cigarette users, the cotinine cut-point that distinguished them from nonusers was 40.5 ng/mL, with considerable variation by sex (male: 22.2 ng/mL; female: 43.1 ng/mL) and between racial/ethnic groups (non-Hispanic other: 5.2 ng/mL; non-Hispanic black: 297.0 ng/mL). A similar, but attenuated, pattern emerged when assessing polytobacco cigarette users (overall cut-point ¼ 39.1 ng/mL, range ¼ 5.5 ng/mL-80.4 ng/mL) and any tobacco users (overall cut-point ¼ 39.1 ng/mL, range ¼ 4.8 ng/mL-40.0 ng/mL). Using TNE-2, which is less impacted by racial differences in nicotine metabolism, produced a comparable pattern of results although reduced the range magnitude. Conclusions: Because of similar frequency of cigarette use among polytobacco users, overall cut-points for exclusive cigarette use were not substantially different from cut-points that included polytobacco cigarette use or any tobacco use. Results revealed important differences in sex and race/ethnicity appropriate cut-points when evaluating tobacco use status and established novel urinary TNE-2 cut-points. Impact: These cut-points may be used for biochemical verification of self-reported tobacco use in epidemiologic studies and clinical trials.

Original languageEnglish (US)
Pages (from-to)1175-1184
Number of pages10
JournalCancer Epidemiology Biomarkers and Prevention
Issue number6
StatePublished - Jun 2021

Bibliographical note

Funding Information:
This manuscript is supported with Federal funds from the National Institute on Drug Abuse, NIH, and the Center for Tobacco Products, Food and Drug Administration, Department of Health and Human Services, under contract to Westat (Contract Nos. HHSN271201100027C and HHSN271201600001C) and through an interagency agreement between the FDA Center for Tobacco Products and the Centers for Disease Control and Prevention.

Funding Information:
M.L. Goniewicz reports receiving a research grant from Pfizer and has served as a member of a scientific advisory board to Johnson & Johnson, manufacturers of smoking cessation medications. R. Niaura reports receiving funding from the Food and Drug Administration Center for Tobacco Products via contractual mechanisms with Westat and the National Institutes of Health. Within the past 3 years, he has served as a paid consultant to the Government of Canada via a contract with Industrial Economics Inc. and has received an honorarium for a virtual meeting from Pfizer Inc. No disclosures were reported by the other authors.

Publisher Copyright:
© 2021 American Association for Cancer Research.

PubMed: MeSH publication types

  • Journal Article
  • Observational Study
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.


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