Revised November 2017
The Population Assessment of Tobacco and Health (PATH) Study is a national longitudinal study of tobacco use and how it affects the health of people in the United States. The PATH Study, launched in October of 2011, is the first large research effort undertaken by the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) since Congress gave FDA authority to regulate tobacco products in 2009.
Approximately 46,000 users and non-users of tobacco products, ages 12 years and older, are participating in the PATH Study. Interviewers meet with each participants once a year for at least three years. The initiative includes seven waves of data collection, with the first wave of data collected from September 2013 to December 2014, and the seventh wave planned to begin in 2022.
By monitoring and assessing behaviors, attitudes, biomarkers, and health outcomes associated with the various tobacco products used in the U.S., the PATH Study will help enhance the evidence base available to inform the FDA’s regulatory decisions and activities related to tobacco products.
Purpose of the PATH Study
The PATH Study is designed to assess the following information:
- Reasons why some people use tobacco and others do not.
- How and why people:
- Start using tobacco,
- Start using different types of tobacco products,
- Use two or more tobacco products, and
- Switch from one tobacco product to another.
- How people quit using tobacco.
- Reasons why some people who quit using tobacco start using it again.
- Changes in people’s attitudes toward tobacco over time.
- Differences in tobacco use-related attitudes, behaviors, and health among:
- Men and women,
- People of different races and ethnic groups, and
- People of different ages.
Scientists at the NIH and the FDA are leading the PATH Study. They are working with Westat, a research company that has expertise in survey design, questionnaire development, data collection, and analysis. Westat manages a team of partner organizations in conducting a variety of health and medical studies.
Partner organizations involved in the PATH Study have expertise in tobacco research, including tobacco use behaviors, health conditions, and research methods. They also lead focused research studies to address the PATH Study’s objectives. The Principal Investigator of the PATH Study is located at one of the partner organizations, Roswell Park Cancer Institute (RPCI). Other scientists participating in the PATH Study include researchers from the following organizations:
- Dartmouth College,
- Rutgers University,
- The Medical University of South Carolina,
- The University of California, San Diego,
- The University of Minnesota, and
- The University of Waterloo.
Data Access and Availability
Data and documentation (questionnaires, codebooks) related to the PATH Study are available on the National Addiction & HIV Data Archive Program (NAHDAP) website, including:
- Public-use files (PUFs) from Waves 1 (Sep 2013–Dec 2014) and 2 (Oct 2014–2015) of data collection.
- Restricted-use files (RUFs) from Waves 1 (Sep 2013–Dec 2014) and 2 (Oct 2014–Oct 2015). Qualified researchers are encouraged to apply for access through the NAHDAP website.
- Biomarker Restricted-use files (BRUFs) from Wave 1 (Sep 2013 – Dec 2014).
- Biospecimen Access Program (BAP) which provides the research community with access to urine, serum, and plasma collected from adult PATH Study participants during Wave 1.
PATH Study Publications
- Villanti AC, Johnson AL, Ambrose BK, et al. Flavored tobacco product use in youth and adults: findings from the first wave of the PATH Study (2013–2014) [published online March 13, 2017]. Am J Prev Med. doi:10.1016/j.amepre.2017.01.026
- Kasza KA, Ambrose BK, Conway KP, et al. Tobacco-product use by adults and youths in the United States in 2013 and 2014. N Engl J Med. 2017;376(4):342-353.
- Hyland A, Ambrose BK, Conway KP, et al. Design and methods of the Population Assessment of Tobacco and Health (PATH) Study [published online August 8, 2016]. Tob Control. doi:10.1136/tobaccocontrol-2016-052934.
- Ambrose BK, Day HR, Rostron B, et al. Flavored tobacco product use among US youth aged 12-17 years, 2013-2014. JAMA. 2015;314(17):1871-1873.
PATH Study Biospecimen Access Program Deadlines
The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) are pleased to announce that the PATH Study’s recently launched Biospecimen Access Program (BAP) has extended the review timeline. Concept Statements for Review Cycle 1 are now due by November 30th, 2017. Applications are due by March 28, 2018.
The Study’s Biospecimen Access Program provides the research community with access to urine, serum, and plasma collected from adult PATH Study participants during Wave 1.
The submission, review, and decision dates for Review Cycles 1 and 2 can be found in the table below. See the National Addiction & HIV Data Archive Program for information on the BAP’s policies, available biospecimens, and application procedures. Investigators proposing meritorious and feasible studies consistent with PATH Study objectives and/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 and/or tobacco-related health outcomes will also be considered.
For more information on the PATH Study including access to the restricted- and public-use questionnaire data files for Waves 1 and 2, please visit National Addiction & HIV Data Archive Program's Population Assessment of Tobacco and Health (PATH) Study Series page.
PATH Study Biospecimen Access
Concept Statement and Application Submission and Review Schedule
|Activity||Review Cycle 1||Review Cycle 2|
|Accept Concept Statements||September 1, 2017 to November 30, 2017||May 1 - 31, 2018|
|Concept Statement Submission Deadline||November 30, 2017||May 31, 2018|
|Concept Statement Review||January 2018||July 2018|
|E-mail Notification of Concept Statement Decision||January 31, 2018||July 31, 2018|
|Accept Applications||February 1, 2018 to March 28, 2018||August 1, 2018 to September 26, 2018|
|Application Submission Deadline||March 28, 2018||September 26, 2018|
|Application Review||April - June 2018||October - December 2018|
|E-mail Notification of Application Decision||July 1 -15, 2018||January 1 - 15, 2019|