On September 19, 2011, the National Institutes of Health (NIH) and Food and Drug Administration (FDA) jointly initiated a national, prospective, longitudinal cohort study to assess tobacco use behaviors and health. The initiative, called the Population Assessment of Tobacco and Health (PATH) Study, is a large-scale NIH-FDA collaboration designed to support FDA efforts to regulate tobacco products under the Family Smoking Prevention and Tobacco Control Act (TCA). Scientific experts at the NIH’s National Institute on Drug Abuse (NIDA) and FDA’s Center for Tobacco Products (CTP) are coordinating this effort through a research contract awarded to Westat in Rockville, MD.
The PATH Study will prospectively follow an estimated 46,000 U.S. household residents who use and do not use tobacco and are 12 years of age and older. The study will:
By measuring and accurately reporting on the social, behavioral, and health effects associated with tobacco-product use in the U.S. over time, the PATH Study will enhance the evidence base available to inform FDA’s regulatory decisions and actions under the TCA.
The TCA gave the Food and Drug Administration (FDA) the authority to regulate the manufacture, marketing, and distribution of tobacco-products. These regulatory changes are expected to influence tobacco-product risk perceptions, exposures, and use patterns in the short term, and to reduce tobacco-related morbidity and mortality in the long term.
The PATH Study is sponsored by the National Institutes of Health’s National Institute on Drug Abuse (NIH/NIDA) in collaboration with the Food and Drug Administration’s Center on Tobacco Products (FDA/CTP). On September 19, 2011, NIH/NIDA awarded a research contract to Westat , an independent research firm in Maryland, to conduct the PATH Study.
The PATH Study objectives are to:
The PATH Study will select and collect information from a nationally representative U.S. household sample of about 46,000 users and non-users of tobacco products, ages 12 years and older.
The study design features include:
The PATH Study will assess tobacco-use variables, covariates, mediators, moderators, and indicators of tobacco exposure and associated health conditions. The PATH Study will enhance the evidence base available to inform FDA’s regulatory decisions and actions under the TCA. Specifically, the study domains include:
Scientific experts at NIH's National Institute on Drug Abuse, in partnership with FDA's Center for Tobacco Products, are coordinating the effort through a contract with Westat , a company in Maryland that specializes in health surveys and public health research. Other partners include leading research institutions and universities.
The PATH Study is a national longitudinal cohort study. The field test for the PATH Study took place between November 2012 and February 2013. Baseline data collection, which will last for 15 months, began in September 2013; the second annual data collection begins mid-October 2014 and will be followed by at least one additional data-collection wave.
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Page last updated: 08/29/2014
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