FAQs for Researchers

On September 19, 2011, the National Institutes of Health (NIH) and Food and Drug Administration (FDA) initiated a joint 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 the first large-scale NIH-FDA collaboration since Congress gave FDA authority to regulate tobacco products under the Family Smoking Protection and Tobacco Control Act (FSPTCA). 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 59,000 U.S. household residents who use and do not use tobacco and are 12 years of age and older. The study will:

• Examine what makes people susceptible to tobacco-product use;
• Evaluate initiation and use patterns, including use of new products, dual use, poly use, and switching of tobacco products;
• Study patterns of tobacco-product use cessation and relapse;
• Track potential behavioral and health impacts, including in risk perceptions and other tobacco-related attitudes, associated with the decisions FDA makes to change tobacco products and meet the objectives of the 2009 FSPTCA; and
• Assess differences in tobacco-related attitudes, behaviors, and health outcomes among racial/ethnic, gender, and age subgroups.

The PATH Study will also collect biospecimens from adults to analyze biomarkers of tobacco use and related health outcomes.

By measuring and accurately reporting on the social, behavioral, and health effects associated with tobacco-product use in the U.S., the PATH Study will provide an empirical evidence base to help the FDA make decisions about future changes in tobacco products and achieve objectives of the 2009 FSPTCA.

The FSPTCA gave the Food and Drug Administration (FDA) the authority to regulate tobacco-product advertising, labeling, marketing, constituents, ingredients and additives. 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.

• FSPTCA also authorizes FDA to:
  • Require disclosure of tobacco product constituents;
  • Regulate modified risk tobacco products;
  • Create standards for tobacco products;
  • Restrict tobacco sales, distribution, and marketing; and
  • Require stronger health warnings on packaging and advertisements.

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 aims to:

• Identify trends in tobacco use patterns, including use of new products, dual use, poly use and switching;
• Characterize tobacco use initiation, dependence, cessation, and relapse patterns;
• Monitor change in risk perceptions and other attitudes such as tobacco product preferences;
• Compare intermediate endpoints and ultimately, short- and long-term incidence/prevalence of health outcomes and cause-specific mortality among users of different products;
• Assess differences between and within critical subgroups including youth, young adults, daily users, racial/ethnic minority groups, and users of new tobacco products; and
• Collect biospecimens to analyze tobacco use-related biomarkers of interest.

The PATH Study will be a nationally representative U.S. household sample of about 59,000 users and non-users of tobacco products, ages 12 and older.

Sample Design

• National representative sample
• Three or more annual waves of assessment
• Annual refreshment of young age cohorts
• Multi-stage sample design, at baseline (N = ~59,600):
  • Households screened: ~101,000
  • Adults completing full interview: ~42,700
  • Youth completing full interview: ~16,900

The PATH Study will assess tobacco-use variables, covariates, mediators, moderators, and behavioral health outcomes. Its findings will support decisions by the FDA in meeting the objectives of the 2009 FSPTCA. Specifically, these include:

• Behavioral health outcomes
  • Tobacco use: general use patterns, initiation, dependence, cessation/quitting, relapse, new products, switching, dual use
  • Health outcomes: short- and long-term
• Regulatory domains
  • Health education campaigns
  • New and modified risk products
  • Product standards
  • Health warnings
• Mediators / moderators
  • Demographics
  • Knowledge, attitudes, beliefs, and risk perceptions
  • Tobacco dependence
  • Peer, environmental, contextual influences
  • Mental health/substance abuse co-morbidities

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. Data collection will begin in fall of 2012, with baseline collection beginning in fall 2013, followed by at least two additional annual data collection waves.