The 2009 Tobacco Control Act charged the FDA with regulating tobacco products in the service of public health. The FDA identified key research priorities, including: understanding the diversity of tobacco products, understanding communications about tobacco products, and understanding tobacco product marketing. Broadening the traditional focus of tobacco control, the FDA calls out "vulnerable populations" in 11 of its 56 research priorities. Over 4 million persons receive some type of addiction treatment annually. In this vulnerable, disenfranchised and stigmatized population, where many receive health services in our public health sector, smoking rates are high (67-75%) and unyielding to prior tobacco control efforts. Because persons in this population are highly likely to smoke, they have high exposure to tobacco marketing and are likely to try, use, and adopt some emerging and potentially modified risk tobacco products. In response to PAR-12-267, the current application will recruit a national stratified random sample of 25 addiction treatment programs, where patients will be recruited to FDA research on tobacco. Patients will be recruited in three annual cross-sectional interview waves (N=1,000 per wave) and, using web-based computer assisted strategies, will be interviewed concerning use of traditional and emerging tobacco products, exposure to FDA communication and tobacco marketing, risk perception related to a range of tobacco products, and tobacco use behavior. The application uses a mixture of measures that are standard, adapted and new measures to test hypotheses that use of any tobacco products remains high over time, that use of modified risk tobacco products increases in this population over time, that exposure to FDA communications and tobacco marketing are differentially associated with level of tobacco risk-perception, and that level of risk perception s differentially associated with efforts to reduce or quit tobacco use in this population. Because this population is where smokers are concentrated, it is also where information identified in FDA priorities is most needed, but least available. The short term goal of this research is to understand use of tobacco products, marketing, messaging, and perceptions associated with those products, and their relation to tobacco use behavior in addiction treatment populations. The long-term goal is to support regulatory activity to reduce tobacco use and tobacco risks in this vulnerable population.

Public Health Relevance

The 2009 Tobacco Control Act assigned regulatory authority over tobacco to the Food and Drug Administration (FDA), and the FDA has asked for research on vulnerable populations. About 4 million persons receive addiction treatment annually, and 67-75% of those are also smokers. Because of their addiction, low income, high smoking rates and social stigma, persons in addiction treatment represent a vulnerable population and are likely to use new tobacco products called potentially modified risk tobacco products (MRTPs). This study will recruit a national sample of treatment programs and interview 1,000 patients per year for each of 3 years. Interviews include use of MRTPs, exposure to FDA communications and tobacco marketing, and perceived risks of tobacco products. The project will study how FDA communication and tobacco marketing affect risk perception, and the interplay of these factors with changes in tobacco use. Findings will support FDA regulatory efforts to reduce tobacco use in this vulnerable and high-prevalence smoking population.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Research Project (R01)
Project #
1R01DA036066-01
Application #
8576930
Study Section
Special Emphasis Panel (ZRG1-HDM-Q (54))
Program Officer
Denisco, Richard A
Project Start
2013-09-30
Project End
2017-08-31
Budget Start
2013-09-30
Budget End
2014-08-31
Support Year
1
Fiscal Year
2013
Total Cost
$719,137
Indirect Cost
$261,574
Name
University of California San Francisco
Department
Social Sciences
Type
Schools of Medicine
DUNS #
094878337
City
San Francisco
State
CA
Country
United States
Zip Code
94143
Nelson, J Craig; Baumann, Pierre; Delucchi, Kevin et al. (2014) A systematic review and meta-analysis of lithium augmentation of tricyclic and second generation antidepressants in major depression. J Affect Disord 168:269-75