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||April 2022*||Fall 2022*|
|Adult Telephone Survey 2020 (Special Collection)||September 2020||December 2020||April 2022*||Fall 2022*|
|Wave 6||March 2021||November 2021||Spring 2023*||Fall 2023*|
|Wave 7||January 2022||December 2022*||Spring 2024*||Fall 2024*|
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 from Youth and Young Adults
The NIH’s National Institute on Drug Abuse (NIDA) and the FDA’s Center for Tobacco Products (CTP) announce the release of new restricted-use biomarker data files from Wave 5 of the Population Assessment of Tobacco and Health (PATH) Study collected December 2018 through November 2019. This latest addition to the PATH Study’s Biomarker Restricted-Use Files (BRUF) is the first release of data from the Wave 4 Biomarker Core, a cohort of participants who were youth as of Wave 4 (12 to 17 years old) and provided biospecimens in Waves 4 and 5 (14 to 19 years old). This release includes urine panel assay data files, namely urinary nicotine metabolites (UNICM), creatinine (CREAU), and metals. It also includes urine biomarker weights for use with the Wave 4 Biomarker Core data, as well as a Youth Urine Collection and Nicotine Exposure Questionnaire (NEQ) file. The Wave 5 Adult Urine Collection and NEQ data file that was released in December 2021 contains corresponding information on adults who are members of the Wave 4 Biomarker Core. Qualified researchers may apply for access through the PATH Study Biomarker Restricted-Use Files webpage.
In addition, the PATH Study Restricted-Use Master Linkage File has been updated to reflect the new BRUF data files.
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/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 people who did and did not use tobacco, were included in the first wave of the PATH Study. At the fourth wave in 2017, about 9,800 more participants joined the 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 currently using tobacco in 2013-14 and roughly 9 percent of youth reported using tobacco in the past 30 days. Multiple product use was common among people who used tobacco, accounting for roughly 40 percent of adult and youth who used tobacco, with cigarettes and e-cigarettes being the most common combination among both age groups.
In March 2022, the first set of widely available PATH Study Data Tables and Figures were released, featuring a series of tables and figures that provide national estimates on tobacco use among youth (aged 12-17), young adults (aged 18-24) and adults (aged 25+) using data from Waves 1-5 (2013-2019) of the PATH Study. These tables and figures are available for public use at PATH Study Data Tables and Figures: Wave 1-5 (2013-2019). They can be easily accessed and are designed to be useful for a wide audience.
These data tables and figures present an easy and quick reference for percentage of people in each age group who use different tobacco products and flavored tobacco, as well as the percentage of people who start using tobacco products or quit smoking cigarettes. In keeping with the goals of the PATH Study, the tables and figures also provide estimates stratified by age, sex, race/ethnicity, and educational attainment to provide information on differences in tobacco use patterns across these demographic subgroups.
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.
- Bansal-Travers, M et al. (2022). Factors associated with changes in flavored tobacco products used: Findings from wave 2 and wave 3 (2014–2016) of the population assessment of tobacco and health (PATH) study. Addictive Behaviors. 130, 107290. https://doi.org/10.1016/j.addbeh.2022.107290
- Tanski, S et al. (2022). Tobacco product use and functionally-important respiratory symptoms among US adolescents/young adults. Academic Pediatrics. https://doi.org/10.1016/j.acap.2022.03.001
- 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
- Sargent, JD et al. (2022). Tobacco use and respiratory symptoms among adults: Findings from the Longitudinal Population Assessment of Tobacco and Health (PATH) Study 2014-16. Nicotine & Tobacco Research. https://doi.org/10.1093/ntr/ntac080
- Chaffee, BW et al. (2022). Oral health in the Population Assessment of Tobacco and Health Study. Journal of Dental Research (p. 002203452210862). https://doi.org/10.1177/00220345221086272
- Gardner, LD et al. (2022). Electronic nicotine delivery system (ENDS) device types and flavors used by youth in the PATH Study, 2016–2019. International Journal of Environmental Research and Public Health. 19, 5236. https://doi.org/10.3390/ijerph19095236
- Stanton, CA et al. (2022). Predictors of e-cigarette and cigarette use trajectory classes from early adolescence to emerging adulthood across four years (2013-2017) of the PATH Study. In Nicotine & Tobacco Research. https://doi.org/10.1093/ntr/ntac119
- Cooper, M et al. (2022). Correlates of tobacco product initiation among youth and young adults between Waves 1 - 4 of the Population Assessment of Tobacco and Health (PATH) Study (2013-2018). Addictive Behaviors (p. 107396). https://doi.org/10.1016/j.addbeh.2022.107396
- Participant Information
Questions and answers for people selected to join the study
- Researcher Information
- 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.
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.