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Population Assessment of Tobacco and Health (PATH) Study

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.

The NIH and FDA announce the availability of questionnaire data from the second wave of the PATH Study. Qualified researchers may apply for access to the restricted-use file (RUF) from the Inter-university Consortium for Political and Social Research (ICPSR)

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.

Study Team

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:

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:

PATH Study Publications

Listed below is a selection of peer-reviewed journal articles from the PATH Study. See the NAHDAP website or search PubMed.gov  for a complete list of publications.

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

For additional information on the PATH study, please contact:
Dr. Heather Kimmel, Ph.D., at 301-443-6504 or heather.kimmel@nih.gov or visit www.pathstudyinfo.nih.gov

This page was last updated November 2017