Revised March 2020
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 fourth wave in late 2017.
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 FDA’s Center for Tobacco Products (CTP) and the NIH’s National Institute on Drug Abuse (NIDA) announce the availability of the first 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). This dataset includes data on urinary metals, creatinine, cotinine, hydroxycotinine, and other nicotine metabolites. Qualified researchers may apply for access through the PATH Study Biomarker Restricted-Use Files webpage at https://doi.org/10.3886/ICPSR36840. Following the release of these biomarker restricted-use files, there will be a release of a special data collection of youth (ages 12- 17) questionnaire data, referred to as “Special Collection Wave 4.5: Youth Only”. This special collection data release will consist of data collected only from youth respondents between Waves 4 and 5 of the PATH Study (from December 2017 to November 2018). Qualified researchers may apply for access to these restricted-use files through the PATH Study Restricted-Use Files webpage at https://doi.org/10.3886/ICPSR36231.
A second special data collection of PATH Study respondents from the Wave 4 cohort (ages 13 – 19) began on December 1, 2019 and will conclude on November 30, 2020. This data collection is referred to as “Special Collection Wave 5.5”. The anticipated population is approximately 4,714 adults (ages 18-19) and 11,129 youth (ages 13-17).
In addition, the Biospecimen Access Program webpage at http://bit.ly/2wBFOtc 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).
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. A ‘PATH Study 101’ video that was developed to provide an orientation to the PATH Study can now be accessed here https://www.youtube.com/watch?v=RWs5YGoRv5Q&feature=youtu.be
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).
Biomarker Restricted-use files (BRUFs)
From Wave 1 (Sep 2013–Dec 2014) and Wave 2 (Oct 2014–Oct 2015).
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.
- Coleman, B. et al. (2018). “Transitions in Electronic Cigarette Use Among Adults in the Population Assessment of Tobacco and Health (PATH) Study, Waves 1 and 2 (2013-2015).” Tobacco Control. doi:10.1001/jamapediatrics.2017.5756.
- Conway, P. K., et al. (2018) “Co-occurrence of tobacco product use, substance use, and mental health problems among youth: Findings from wave 1 (2013-2014) of the population assessment of tobacco and health (PATH) study.” Addict Behav. 2018 Jan;76:208-217. doi: 10.1016/j.addbeh.2017.08.009. Epub 2017 Aug 18.
- Goniewicz, ML et al. (2018). “Comparison of Nicotine and Toxicant Exposure in Users of Electronic Cigarettes and Combustible Cigarettes.” JAMA Netw Open. 2018 Dec 7;1(8):e185937. doi : 10.1001/jamanetworkopen.2018.5937.
- Green, VR, et al. (2018). “Mental Health Problems and Onset of Tobacco Use Among 12- to 24-Year-Olds in the PATH Study.” J Am Acad Child Adolesc Psychiatry. 2018 Dec;57(12):944-954.e4. doi: 10.1016/j.jaac.2018.06.029. Epub 2018 Oct 4.
- Green, VR, et al. (2018) “Body mass index and tobacco-product use among U.S. youth: Findings from wave 1 (2013-2014) of the Population Assessment of Tobacco and Health (PATH) Study.” Addict Behav. 2018 Jun;81:91-95. doi: 10.1016/j.addbeh.2018.02.005. Epub 2018 Feb 5.
- Pierce, J. P., et al. (2018). “Association Between Receptivity to Tobacco Advertising and Progression to Tobacco Use in the Youth and Young Adults in the PATH Study.” JAMA Pediatrics 172(5): 444-451]. doi: 10.1136/tobaccocontrol-2017-054174.
- Silveira, L. M., et al. (2018) “Longitudinal associations between youth tobacco and substance use in waves 1 and 2 of the Population Assessment of Tobacco and Health (PATH) Study.” Drug and Alcohol Dependence. 191 (2018) 25-36. doi: 10.1016/j.drugalcdep.2018.06.018. Epub 2018 Jul 25.
- 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, Cassandra A et al (2019). “Longitudinal e-cigarette and cigarette use among US youth in the PATH Study (2013-2015).” Journal of the National Cancer Institute, djz006, https://doi.org/10.1093/jnci/djz006
Questions and answers for people selected to join the study
Questions and answers about the study and how to access the data and biospecimens
FDA PATH Study page
Information from the FDA
- The PATH Study FAQs can be found here: https://www.icpsr.umich.edu/icpsrweb/content/NAHDAP/path-study-faq.html.
- 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.
For specific inquiries regarding the PATH Study BAP and procedures for access to the biospecimens, contact the PATH Study team at PATHStudyBiospecimens@westat.com.
The BAP-specific FAQs can be found here: https://www.icpsr.umich.edu/icpsrweb/content/NAHDAP/pathstudy-faq.html