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 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.
The NIH NIDA and the FDA Center for Tobacco Products announce the availability of the second in a series of restricted-use biomarker data files from the third wave of the Population Assessment of Tobacco and Health (PATH) Study. This latest addition to the PATH Study’s Biomarker Restricted-Use Files (BRUF) contains data collected during Wave 3 (October 2015 – October 2016) and includes two urine panel assay data files, namely tobacco-specific nitrosamines (TSNA) and volatile organic compounds metabolites (VOCM). Qualified researchers may apply for access through the PATH Study Biomarker Restricted-Use Files webpage. In addition to the release of these biomarker restricted-use files, there will be a release of (1) a state design restricted-use file (SDRUF) that includes the state identifier for study participants at the time of selection and recruitment for the PATH Study at Wave 1 or Wave 4; (2) Wave 2 – Wave 4 state identifier restricted-use files (SIRUF) that include variables for linking the state identifier to the questionnaire and biomarker data, and variables designating the state (state FIPS, state abbreviation, and full name of the state); and (3) Wave 1 – Wave 4 tobacco universal product code restricted-use files (TUPCRUF)that contain universal product code (UPC) values on the packages of tobacco products used or in the possession of adult respondents, which may be used to identify and validate the specific products used by respondents and augment the analyses of the characteristics of tobacco products used by respondents.Qualified researchers may apply for access to these restricted-use files through the PATH Study Restricted-Use Files webpage.
The complete list of newly released files includes the following:
- Wave 3 BRUF (Part 2)
- State Design Data
- Wave 1: Tobacco Universal Product Code (TUPCRUF) Data
- Waves 2-4:
- Tobacco Universal Product Code (TUPCRUF) Data
- Adult State Identifier Data (SIRUF)
- Youth / Parent State Identifier Data (SIRUF)
In addition, the Biospecimen Access Program webpage provides information on how to access the urine, serum, and plasma collected from adult PATH Study participants during Wave 1 and Wave 2.
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:
- Questionnaire Public-use files (PUFs)
From Wave 1 (Sep 2013–Dec 2014), Wave 2 (Oct 2014–Oct 2015), Wave 3 (Oct 2015-Oct 2016), and Wave 4 (Dec 2016-Jan 2018).
- Questionnaire Restricted-use files (RUFs)
From Wave 1 (Sep 2013–Dec 2014), Wave 2 (Oct 2014–Oct 2015), Wave 3 (Oct 2015 - Oct 2016), and Wave 4 (Dec 2016-Jan 2018) ), and Wave 4.5 (Dec 2017-Nov 2018).
- Biomarker Restricted-use files (BRUFs)
From Wave 1 (Sep 2013–Dec 2014) and Wave 2 (Oct 2014–Oct 2015), and Wave 3 (Oct 2015- Oct 2016).
- State Identifier Restricted-use files (SIRUFs)
From Wave 1 (Sep 2013–Dec 2014).
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:
- Biospecimen Access Program (BAP)
Access to urine and blood collected from adult PATH Study participants in Waves 1 and 2, and DNA collected from adult PATH Study participants in Wave 1.
- 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
- Coleman, B. et al (2019). “An Examination of Device Types and Features Used by Adult Electronic Nicotine Delivery System (ENDS) Users in the PATH Study, 2015–2016.” Int. J. Environ. Res. Public Health 2019, 16, 2329.
- Rose, SW et al. (2019). “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.21 September 2019. doi: 10.1136/tobaccocontrol-2018-054852
- Silveira, ML et al. (2019). “Patterns and correlates of poly-substance use among U.S. youth ages 15-17 years: Wave 1 of the population assessment of tobacco and health (PATH) study.” Addiction. 2019 Jan 4. doi: 10.1111/add.14547.
- Stanton, CA et al (2019). “Longitudinal e-cigarette and cigarette use among US youth in the PATH Study v(2013-2015).” Journal of the National Cancer Institute, djz006, https://doi.org/10.1093/jnci/djz006
- Strong, DR et al (2019). “Harm perceptions and tobacco use initiation among youth in Wave 1 and 2 of the Population Assessment of Tobacco and Health (PATH) Study”. J Preventive Medicine, 2019; 23:185-191. https://doi.org/10.1016/j.ypmed.2019.03.017.
- Strong, DR et al (2019). “Youth perception of harm and addictiveness of tobacco products: Findings from the Population Assessment of Tobacco and Health Study (Wave 1)”. J Addictive Behaviors, 2019; 92:128-135. https://doi.org/10.1016/j.addbeh.2018.12.005.
- Villanti AC et al. (2019). “Association of Flavored Tobacco Use With Tobacco Initiation and Subsequent Use Among US Youth and Adults, 2013-2015.” JAMA Netw Open. 2019;2(10):e1913804. doi:10.1001/jamanetworkopen.2019.13804
- 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 the new Westat email: 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.