Recent Studies

UW-CTRI has recently completed four studies, with data under analysis for dissemination.

1. Exhale Study. As the federal government considers how to regulate electronic cigarettes (e-cigs), the University of Wisconsin was awarded a $3.7 million, 5-year grant from the National Cancer Institute as well as the Food and Drug Administration to study them over five years. This research provided in-depth, longitudinal information, based on real-time reports, which addresses key priorities that may inform regulatory and health concerns, including understanding the relations between vaping and nicotine dependence; changes in rates of smoking conventional cigarettes; health outcomes such as evidence of exposure to carcinogens, as well as acute and long-term pulmonary health; attempts to quit smoking and the success of those attempts. Specifically, researchers identified and tracked over time 150 participants who exclusively smoke cigarettes and 250 participants who both smoke and vape. Researchers used smart phones and other tools to collect information on patterns of use of these products, levels of addiction, withdrawal symptoms, success quitting versus relapse, lifestyle factors, carcinogen exposure, and how one group of participants compares to the other over time. This research provided essential information to inform regulatory bodies, as well as researchers, clinicians, and tobacco users, about the patterns of real-world e-cig use and how such use is related to conventional smoking and the health risks caused by it. March 2015–February 2020, $3.7 million. Funded by the National Cancer Institute of the National Institutes of Health, and the Food and Drug Administration. Dr. Megan Piper and Dr. Douglas Jorenby, PIs.

2. PTSD and Veterans Merit Award. UW-CTRI Researcher Dr. Jessica Cook led this merit award research at the William S. Middleton Memorial Veterans Hospital in Madison, Wisconsin. The primary objective of this research was to produce an empirically validated treatment that increases smoking cessation in Veterans with posttraumatic stress disorder (PTSD), one that can be easily integrated into smoking cessation clinics and/or mental health clinics within VA facilities. Evidence shows that behavioral activation therapy (BA), a behavioral treatment that increases engagement in reinforcing activities, significantly reduces PTSD symptoms and may aid in quitting smoking. The research was designed to determine whether BA, as an adjunct to standard smoking-cessation treatment, (ST+BA) is superior to a comparably intense combination of standard smoking cessation treatment + health and smoking education (ST+HSE) in improving smoking cessation outcomes among Veterans with PTSD. The HSE intervention was intended to constitute a credible intervention that controls for contact time. Secondary objectives were to determine if BA improves PTSD symptomatology and associated affective distress, and to identify potential mediators of BA on smoking outcomes. A total of 124 Veterans with PTSD who were motivated to quit smoking have attended an initial diagnostic and baseline assessment session. All participants will receive 8 weeks of the nicotine patch. Smoking-cessation outcomes are being assessed 2, 4, 8, 16, and 26 weeks after the quit date. Jan. 2014-Sept. 2019, $770,500. Funded by the United States Department of Veterans Affairs. Jessica Cook, PI.

3. Breaking Addiction to Tobacco for Health (BREATHE). This project tested new phased-based treatments to help patients in the Milwaukee and Madison areas quit smoking. Partners in this research included colleagues from Penn State University and the University of Illinois-Chicago, as well as Aurora Health Care, Dean Health System, and Epic. Under the BREATHE project, any smoker who visited a participating clinic, regardless of the initial reason for the visit, was invited to get treatment through BREATHE. This study implemented both an electronic health records (EHR) system that increased smokers’ recruitment into treatment as well as a highly effective chronic-care treatment with intervention components for all smokers. First, the EHR system was implemented in 18 clinics in two health-care systems and experimentally evaluated on its ability to increase the recruitment of smokers into chronic-care treatment (Project 1). Then, using highly efficient research methods, researchers experimentally compared multiple intervention components and identified especially effective interventions for every phase of smoking treatment. This included motivating smokers initially unwilling to quit and preparing them for cessation (Project 2), enhancing quitting success and preventing relapse when smokers are ready to quit (Project 3), and re-engaging relapsed smokers in treatment and restoring their abstinence (Project 4). BREATHE researchers have been formulating an optimized, comprehensive, chronic-care treatment for smoking that can be readily implemented in primary care settings by project end. June 2014-July 2019, $12 million. Funded by the National Cancer Institute of the National Institutes of Health. Michael Fiore and Tim Baker, PIs.

4. Genetically Informed Smoking Cessation Trial. This randomized clinical trial was the first genetic study to look at nicotine-replacement therapy (NRT) vs. varenicline head-to-head, and how participants with different genetics respond to the medications. Led by Li-Shiun Chen with collaboration from UW-CTRI Research Director Dr. Tim Baker and UW-CTRI Director of Clinical Services Dr. Doug Jorenby, the researchers hoped to determine whether genetic markers can be used to optimize smoking cessation pharmacotherapy to enhance efficacy, medication adherence, and reduce side effects. The researchers’ recent work, which suggested that the nicotinic receptor gene CHRNA5 alters the response to NRT, has been replicated in a meta-analysis. This study of 720 smokers used a stratified randomization trial design based on a subject’s pertinent genotype for smoking cessation. Specifically, in Aim 1, researchers determined if CHRNA5 genotype moderates the effect of medication (combination NRT, varenicline, vs. placebo) on abstinence. In Aim 2, researchers determined if CHRNA5 genotype predicts medication adherence and side effects. In Aim 3, researchers incorporated multiple genotypes and other predictors in order to develop a clinical treatment assignment algorithm for cessation success. This work could result in improved physician care of patients who smoke, overall smoking cessation success, and prevention of cancer, heart, and lung disease. Sept. 2014-July 2019, $90,000. Funded by the National Institutes of Health. Li-Shiun Chen, PI. Douglas Jorenby, co-PI.