What is the PATH Study?
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 sixth wave in late 2021. Below is a table of data collection waves.
|Wave #||Begin Date||End Date||Restricted-Use File Data Release Date||Public-Use File Data Release Date|
|Wave 1||September 2013||December 2014||December 2015||August 2016|
|Wave 2||October 2014||October 2015||March 2017||June 2017|
|Wave 3||October 2015||October 2016||May 2018||September 2018|
|Wave 4||December 2016||January 2018||May 2019||November 2019|
|Wave 4.5 (Special collection)||December 2017||December 2018||March 2020||September 2020|
|Wave 5||December 2018||November 2019||February 2021||September 2021|
|Wave 5.5 (Special Collection)||December 2019||December 2020||Spring 2022*||Fall 2022*|
|Adult Telephone Survey 2020 (Special Collection)||September 2020||December 2020||Spring 2022*||Fall 2022*|
|Wave 6||March 2021||November 2021||Spring 2023*||Fall 2023*|
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.
New PATH Study Data Files Available
The NIH’s National Institute on Drug Abuse (NIDA) and the FDA’s Center for Tobacco Products (CTP) announce the release of special collection restricted use data files (SCRUFs) from Wave 5.5 and from the Population Assessment of Tobacco and Health (PATH) Study Adult Telephone Survey (ATS). The Wave 5.5 Special Collection data were collected from youth participants ages 13 to 19 between July and December 2020. Data in the PATH-ATS were collected between September and December 2020 from a subsample of adult participants ages 20 and older, complementing the Wave 5.5 Special Collection. Researchers may apply for access to the SCRUF.
In addition, the PATH Study Restricted-Use Files (RUF) have been updated to include Wave 5 Ever/Never Reference Data for all participants. The Restricted-Use and Public-Use Master Linkage Files have each been updated to reflect the new SCRUF files and the current availability of biospecimens in the Biospecimen Access Program.
Access data and documentation for Public-Use Files. Qualified researchers from the research community can apply for access to the Restricted-Use Files and the Biomarker Restricted-Use Files. In addition, the Biospecimen Access Program webpage provides information on how to access the urine, serum, plasma, and genomic DNA (gDNA) collected from adult PATH Study participants during Wave 1 (2013 – 2014) and urine collected during Wave 2 (2014 – 2015), Wave 3 (2015-2016), Wave 4 (2016-2018), and Wave 5 (2018-2019).
The PATH Study is a household-based, nationally representative, longitudinal cohort study of youth (12-17 years old) and adults in the United States. The study was launched in 2011 to inform FDA’s regulatory activities under the Family Smoking Prevention and Tobacco Control Act. For the latest announcements, data releases and updates, new publications, upcoming events, and other information for PATH Study data users, join the PATH Study Data User Forum. The forum enables researchers using PATH Study data to submit and answer questions.
Questions about the collection, content, weighting, documentation, or structure of PATH Study data may be submitted to PATHDataUserQuestions@Westat.com (not to be used for questions about statistical analysis or analytic guidance).
Interested in Learning More?
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
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);
- 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.
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 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. Available file types include Questionnaire Public-use Files (PUFs), Questionnaire Restricted-use Files (RUFs), Biomarker Restricted-use Files (BRUFs), State Identifier Restricted-use Files (SIRUFs), Tobacco Universal Product Code (TUPCRUF) Data, Special Collection Public-use Files (SCPUFs), and Special Collection Restricted-use Files (SCRUFs). Data from new waves are 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:
- Biospecimen Access Program (BAP)
Access to urine, blood, and gDNA collected from adult PATH Study participants.
- Anic, GM et al. (2022). Changes in biomarkers of tobacco exposure among cigarette smokers transitioning to ENDS use: The Population Assessment of Tobacco and Health Study, 2013-2015. International Journal of Environmental Research and Public Health. 19 (3) 1462. https://doi.org/10.3390/ijerph19031462
- Kasza KA, Edwards KC, and Kimmel HL. (2021). Association of e-cigarette use with discontinuation of cigarette smoking among adult smokers who were initially never planning to quit. JAMA Network Open. 4 (12) e2140880. https://doi.org/10.1001/jamanetworkopen.2021.40880
- Smith, DM et al. (2021). Exposure to nicotine and toxicants among dual users of tobacco cigarettes and e-cigarettes: Population Assessment of Tobacco and Health (PATH) Study, 2013-2014. Nicotine and Tobacco Research. 23 (5) 790-797. https://doi.org/10.1093/ntr/ntaa252
- Halenar, MJ et al. (2021). Validation of an index for functionally important respiratory symptoms among adults in the nationally representative Population Assessment of Tobacco and Health Study, 2014–2016. International Journal of Environmental Research and Public Health. 18 (18) 9688. https://doi.org/10.3390/ijerph18189688
- Mahoney, MC et al. (2021). Cardiovascular risk factor and disease measures from the Population Assessment of Tobacco and Health (PATH) Study. International Journal of Environmental Research and Public Health. 18 (14) 7692. https://doi.org/10.3390/ijerph18147692
- 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
- 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
- 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 Westat by e-mail: PATHDataUserQuestions@Westat.com.
- For specific inquiries regarding the PATH Study BAP and procedures for access to the biospecimens, contact the PATH Study team at PATHStudyBiospecimens@westat.com.