Population Assessment of Tobacco and Health (PATH) Study

What is the PATH Study?

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The Population Assessment of Tobacco and Health (PATH) Study is a nationally representative longitudinal study of tobacco use and health in the United States. A collaboration between the National Institutes of Health (NIH) National Institute on Drug Abuse (NIDA) and the U.S. Food and Drug Administration (FDA) Center for Tobacco Products, the study was launched in 2011, started the first wave of data collection in 2013, and completed its fifth wave in late 2019.

Following the release of these biomarker restricted-use files, a special data collection of youth (ages 12- 17) questionnaire data, referred to as “Special Collection Wave 4.5: Youth Only” was released. This special collection data release consisted of data collected only from youth respondents between Waves 4 and 5 of the PATH Study (from December 2017 to November 2018).

By following study participants over time, the PATH Study helps scientists learn how and why people start using tobacco products, quit using them, and start using them again after they’ve quit, as well as how different tobacco products affect health outcomes (such as cardiovascular and respiratory health) over time. Most participants complete the study questionnaire every other year.

Study Team

Scientists at NIDA and the FDA are leading the PATH Study. They are working with Westat, a research company with expertise in survey design, questionnaire development, data collection, and analysis. Westat also manages a team of partner organizations working on the Study.

The Principal Investigator of the PATH Study is located at Roswell Park Comprehensive Cancer Center. Other participating scientists are from:

• Centers for Disease Control and Prevention
• Dartmouth College
• The Medical University of South Carolina
• New York University
• Rutgers University
• Truth Initiative (formerly Legacy)
• The University of California, San Diego
• The University of Minnesota
• The University of Nevada, Reno
• The University of Vermont
• The University of Waterloo

Goals

By monitoring and assessing behaviors, attitudes, biomarkers, and health outcomes associated with tobacco use in the United States, the PATH Study helps enhance the evidence base informing FDA’s regulatory activities related to tobacco. Specifically, the study aims to:

• Examine susceptibility to tobacco product use;
• Study the progression of tobacco product use, including initiation, dependence, cessation, and relapse;
• Evaluate patterns of tobacco use, including:
  • use of newer products, such as e-cigarettes or ENDS (electronic nicotine delivery systems);
  • poly-use;
  • switching products;
• Track potential behavioral and health impacts, including biomarkers of exposure and potential harm; and
• Assess differences in tobacco-related attitudes, behaviors, and health conditions among racial/ethnic, gender, and age subgroups over time.

Initial Findings

About 46,000 people aged 12 years and older, including tobacco users and non-users, were included in the first wave of the PATH Study.

Initial data on adult and youth tobacco use, published January 2017 in the New England Journal of Medicine, showed that more than 25 percent of American adults were current users of tobacco in 2013-14 and roughly 9 percent of youth reported using tobacco in the past 30 days. Multiple product use was common among tobacco users, accounting for roughly 40 percent of adult and youth tobacco users, with cigarettes and e-cigarettes being the most common combination among both age groups.

Among tobacco users who reported using more than one product:

• 23 percent of adults and 15 percent of youth used cigarettes and e-cigarettes
• 6 percent of adults and 4 percent of youth used cigarettes and hookah
• 2 percent of adults and 5 percent of youth used e-cigarettes and hookah
• 5 percent of adults and 10 percent of youth used cigarettes and cigarillos

The study reports prevalence for additional product combinations used by study participants.

Data Access

Data and documentation (questionnaires, codebooks) related to the PATH Study are available at the study website at the National Addiction & HIV Data Archive Program (NAHDAP), including instructions for access to restricted- and public-use files:

Data from additional waves will be released as they become available.

Biospecimen Access Program (BAP)

Biospecimens collected from PATH Study participants are also available to the research community. Investigators proposing meritorious and feasible studies consistent with PATH Study objectives or research priorities for tobacco regulatory science will be given highest priority for access to these biospecimens. Proposals addressing other objectives that advance the knowledge of tobacco use or tobacco-related health outcomes will also be considered. There are two submission and review cycles per year, beginning in September and May. Application instructions and deadlines are available at the PATH Study webpage on the NAHDAP website:

Journal Publications

Listed below is a selection of peer-reviewed journal articles using data from the PATH Study. See the PATH Study website at NAHDAP or search PubMed.gov for a complete list of publications.

• Patterns of Tobacco Product Use in the United States: Transitions across Three Waves of the PATH Study (2013-2016). Tobacco Control 2020;29. (The issue includes a series of peer-reviewed papers analyzing tobacco product use transitions among U.S. youth, young adults, and adults using data from the Population Assessment of Tobacco and Health (PATH) Study. Five articles focus on transitions among current users of various tobacco products (cigarette, e-cigarette, hookah, cigar, and smokeless).  Moreover, four papers assess initiation, cessation, and relapse. This special issue of Tobacco Control is a collaboration between FDA, NIDA, CDC, Westat and Roswell Park Comprehensive Cancer Center.)
• Cheng, YC et al. (2020). “Biomarkers of Exposure among Adult Smokeless Tobacco Users in the Population Assessment of Tobacco and Health Study (Wave 1, 2013-14).” Cancer Epidemiology Biomarkers & Prevention, cebp.0766.2019. https://doi.org/10.1158/1055-9965.epi-19-0766
• De Jesus VR et al. (2020) Urinary biomarkers of exposure to volatile organic compounds from the Population Assessment of Tobacco and Health Study Wave 1 (2013-2014). International Journal of Environmental Research and Public Health. 17, (15), 5408. https://doi.org/10.3390/ijerph17155408
• Kasza KA et al. (2020) Adults' e-cigarette flavor use and cigarette quit attempts: Population Assessment of Tobacco and Health study findings. American Journal of Preventive Medicine. https://doi.org/10.1016/j.amepre.2020.06.017
• Pearson, JL et al. (2020). “Association of Electronic Nicotine Delivery System Use With Cigarette Smoking Progression or Reduction Among Young Adults.” JAMA network open 3,11 e2015893. 2 Nov. 2020, https://doi.org/10.1001/jamanetworkopen.2020.15893.
• Pierce JP (2020) Role of e-cigarettes and pharmacotherapy during attempts to quit cigarette smoking: The PATH Study 2013-16. PLOS One. 15, (9), e0237938. https://doi.org/10.1371/journal.pone.0237938
• Rose SW (2020) Flavour types used by youth and adult tobacco users in wave 2 of the Population Assessment of Tobacco and Health (PATH) Study 2014–2015. Tobacco Control. 29, (4), 432-446. https://doi.org/10.1136/tobaccocontrol-2018-054852
• Rostron BL et al. (2020). Nicotine Exposure by Device Type among Adult Electronic Nicotine Delivery System Users in the Population Assessment of Tobacco and Health Study, 2015-2016. Cancer epidemiology, biomarkers & prevention: a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology 29,10 (2020): 1968-1972. https://doi.org/10.1158/1055-9965.EPI-20-0317
• Strong DR et al. (2020) Findings from waves 1 and 2 of the Population Assessment of Tobacco and Health (PATH) study. Drug and Alcohol Dependence. 214, (108134) https://doi.org/10.1016/j.drugalcdep.2020.108134
• Travers MJ et al. (2020) Biomarkers of exposure among USA adult hookah users: Results from Wave 1 of the Population Assessment of Tobacco and Health (PATH) Study (2013-2014). International Journal of Environmental Research and Public Health. 17, (17), Article no. 6403. https://doi.org/10.3390/ijerph17176403
• Villanti, AC et al. (2020) Menthol and mint cigarettes and cigars: Initiation and progression in youth, young adults and adults in Waves 1 - 4 of the PATH Study, 2013 - 2017. Nicotine and Tobacco Research, ntaa224 https://doi.org/10.1093/ntr/ntaa224
• Xia, B et al. (2020) Tobacco-specific nitrosamines (NNAL, NNN, NAT, and NAB) exposures in the US Population Assessment of Tobacco and Health (PATH) Study Wave 1 (2013-2014). Nicotine and Tobacco Research. 23, (3), 573-583. https://doi.org/10.1093/ntr/ntaa110

Additional Resources

• Participant Information
  Questions and answers for people selected to join the study
• Researcher Information
  Questions and answers about the study and how to access the data and biospecimens
• FDA PATH Study page
  Information from the FDA

Questions?

Contact PATHStudyinfo@westat.com.

• PATH Study FAQs
• To communicate with other researchers using the PATH Study data, consider joining the PATH Study Data User Forum hosted by NAHDAP. Announcements, data releases and updates, new publications, upcoming events, and other information for PATH Study data users will also be posted to the forum.
• Questions about the collection, content, weighting, documentation, or structure of PATH Study data may be submitted to the new Westat email: PATHDataUserQuestions@Westat.com.
  NOTE: This email address is not for questions about statistical analysis or analytic guidance. For analytic questions, researchers may wish to consult with statisticians and analysts at their institutions. Additionally, the PATH Study User Forum can be used to obtain feedback and engage in discussion with other PATH Study data users.
• For specific inquiries regarding the PATH Study BAP and procedures for access to the biospecimens, contact the PATH Study team at PATHStudyBiospecimens@westat.com.
  • BAP-specific FAQs