Active Studies

In the first half of 2025, UW-CTRI had nine active studies. These included:

1. Machine learning approaches to personalized cigarette smoking risk prediction in adults trying to quit. This Career Development Award from the National Institute of Health’s (NIH) National Institute of Drug Abuse will provide support for Dr. Jesse Kaye and a team of UW-CTRI researchers to explore how machine learning (a subfield of artificial intelligence, or “AI”) might help to personalize treatment in real time for people trying to address their tobacco use. Personalization of tobacco treatment may improve effectiveness, enhance sustained treatment engagement, and increase quitting success. Digital health tools have tremendous potential to enhance personalization of tobacco treatment and facilitate delivery of support relevant to an individual’s needs when and where it is most needed. At the beginning of treatment, digital tools may help integrate information on diverse risk and protective factors to personalize treatment selection (e.g., medication type) and planning (e.g., addressing modifiable risk factors). As treatment progresses, digital tools may help detect changes in risk to facilitate personalized treatment adjustments or just-in-time interventions. This K23 research will use sophisticated, high-dimensional data analytic approaches to account for the complexity of influences on smoking lapses and relapses during quit attempts, and to develop robust and effective personalized risk predictions and interventions. UW-CTRI researchers will apply state-of-the-art machine learning methods to rich existing smoking cessation clinical trial datasets (>3000 participants) to develop, train, and validate personalized smoking risk predictions. These smoking risk prediction models will form the foundation of a program of research to ultimately develop novel personalized feedback interventions that can efficiently provide the right treatment, for the right person, at the right moment in time. Dr. Kaye will receive mentorship and training from Drs. Danielle McCarthy, Tim Baker, Dan Bolt, Wei-Yin Loh, and Michael Businelle. September 2025 – August 2030. $1 million. K23 Funded by the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH). Dr. Jesse Kaye, PI.
2. Comparing Three Multicomponent Interventions to Help Adults Quit Smoking. Black Americans in Wisconsin and across the United States continue to face significant smoking-related health inequities that are exacerbated by menthol tobacco use and tobacco industry targeting. This study will examine the effects of three treatment packages for Black adults who want to quit smoking as part of a five-state study (in Arizona, Indiana, Kansas, Virginia and Wisconsin). The 1500 participants will be randomized to one of the three treatment packages: Standard, Intensive, or Intensive Incentivized Package. The Standard Package will provide 4 counseling sessions and 2 weeks of nicotine patches, similar to a typical state-run quitline. The Intensive Package will provide 8 weeks of nicotine patches, 8 culturally specific counseling sessions (participants can choose whether to have in-person group counseling or individual phone counseling) and access to the Pathways to Freedom video (a video designed to help Black adults quit smoking) on the study website. The Intensive Incentivized Package will be the same as the Intensive Package and will also provide up to $50 in incentives for participants to attend counseling sessions. These three treatment packages were selected because the individual components have been shown to be effective among Black adults trying to quit smoking and because the study’s Community Advisory Board (CAB), with feedback from focus groups of Black adults who smoke, deemed them to be acceptable and feasible. The goal of this research is to determine whether the culturally specific packages being tested in this study will increase quit rates relative to the standard evidence-based package. Importantly, these treatments will not be provided in clinical settings but in the participants’ everyday lives and settings. The study will also investigate the best ways to engage Black adults in these low-barrier treatments. June 2025-June 2029. Total budget over five years of $10 million. Funded by the Patient-Centered Outcomes Research Institute (PCORI). Drs. Megan Piper and Hasmeena Kathuria, PIs.
3. Options 2 Study. (A Randomized Comparative Effectiveness Trial of Nicotine Pouches for Cigarette Substitution: A Question of Public Health) UW-CTRI is testing whether nicotine pouches can replace smoking among participants in a randomized comparative effectiveness study. Nicotine pouches—microfiber sachets containing powered nicotine but no tobacco leaf—are a new class of oral tobacco products rapidly growing in popularity. One popular brand is known as Zyn. However, we currently know very little about how readily people who smoke adopt nicotine pouches, how effectively pouches can substitute for cigarettes when participants are trying to avoid smoking, the importance of nicotine dose in effective cigarette substitution and the mechanisms that may promote or hinder product transition. To address these key gaps, researchers are enrolling 300 adults who smoke daily and are not planning to quit in the next 30 days. Participants are randomly assigned to one of four product conditions: 1) 3-mg nicotine pouches; 2) 6-mg nicotine pouches; 3) nicotine mini-lozenges (2- or 4-mg); or 4) no study product. Participants receiving a study product (nicotine pouches or nicotine mini lozenges) are asked to use them for four weeks, an initial experimentation week and then for a three-week switching trial where they are asked not to smoke their usual cigarettes and instructed instead to use their study product (if assigned one). Before and after the switching trial, participants come to the clinic following overnight abstinence and use their assigned product (if any) during a 30-minute sampling test to assess the duration of product use, subjective evaluations of study products and suppression of craving and withdrawal symptoms under controlled conditions. During the four weeks of the study, participants use a smartphone app to record, in real-time, each time they use cigarettes or a study product. For a random daily subset of use events, participants answer additional questions about the context of their use (e.g., affect, any restrictions on smoking) and potential mechanisms driving use (e.g., withdrawal alleviation, satisfaction). September 2024-August 2029. Total budget over five years of $3.8 million. R01 Funded by the National Cancer Institute, NIH. Drs. Tom Piasecki and Megan Piper, MPIs.
4. Avenues Study. (Dual Use Cessation: A MOST screening trial to identify effective interventions for people who smoke and vape) For people who both smoke and vape, there are new paths to help them address their relationship with nicotine. The goal of the research is to identify the most effective ways to help people who both smoke and vape to quit smoking. Researchers are recruiting 500 people who both smoke and vape. Participants are randomized to one of two levels of each treatment factor: Medications—participants get either varenicline or nicotine patch. Counseling approach—participants are either encouraged to just quit smoking (and keep vaping) or to quit both smoking and vaping. Counseling intensity—participants get either one coaching session or four sessions. Participants can earn up to $445 by completing the year-long study. Participants use smartphones to share information with researchers two weeks before and after their quit dates. Participants record smoking, vaping, medication use, craving levels, self-efficacy and other insights every evening. To date, no published studies have identified effective ways to help people who both smoke and vape to quit smoking. May 2024-May 2029. Total budget over five years of $4.3 million. R01 funded by the National Cancer Institute, NIH. Megan Piper and Dr. Tim Baker, MPIs.
5. Helping Young People Quit Vaping. (Addressing the Vaping Epidemic in Adolescents and Young Adults: Advancing our Understanding of Cessation Treatment and Engagement) More than 1.4 million adolescents and 4.7 million young adults in the United States report vaping, according to FDA and CDC’s National Youth Tobacco Survey. The majority never smoked cigarettes. The goal of this K08 training grant is to improve our understanding of how to engage adolescents and young adults in vaping cessation treatment and ultimately discover how best to help them to quit vaping. Dr. Williams and his colleagues examine youth and young adult perspectives on quit-vaping interventions such as This is Quitting. Williams plans to evaluate the feasibility, acceptability and preliminary efficacy of two enhancements to This is Quitting—financial incentives and FDA-approved medications. In addition, Williams uses data from the PATH Study to better identify predictors of quit attempts as well as success. April 2024-April 2029. Total budget over five years of $967,000. K08 Funded by National Institute on Drug Abuse, NIH. Dr. Brian Williams, PI.
6. Vape Check. (The Longitudinal Effects of E-cigarette Use on Cardiovascular and Pulmonary Health Study) This award continues a long-standing successful research collaboration between Drs. Jim Stein and Tim Baker as they examine the long-term effects of vaping on heart and lung health. Participants receive up to $675 for completing the 3-year study. They also receive individualized test results and updates on their health. Although prior studies have examined some of the physical effects of vaping, virtually all of these have examined very short-term or cross-sectional effects. In contrast, Vape Check follows people who vape over multiple years. Vape Check is helping to set the record straight regarding the health effects of vaping. September 2024-September 2029. Total budget over five years of $5.7 million. R01 Funded by the National Heart, Lung and Blood Institutes. Drs. Tim Baker and James Stein, MPIs.
7. Salvation Army Study. UW-CTRI partners with the Salvation Army of Wisconsin and Upper Michigan on a new $6 million grant to evaluate sustainable strategies Salvation Army staff can use to connect their adult participants who use tobacco with the Wisconsin Tobacco Quit Line for free tobacco treatment.Wisconsin Salvation Army social service leaders, staff and participants play leading roles in planning, monitoring and adapting Wisconsin Tobacco Quit Line connection implementation strategies so they fit well in the usual context of Salvation Army services. Specifically, they adapt two promising strategies supported by preliminary research. One promising strategy being evaluated in this project is an enhanced model of support for Salvation Army implementation teams. This is being compared against the usual UW-CTRI regional outreach support model in different Salvation Army service centers. The second strategy to be tested is focused on giving participants an incentive to talk with a Wisconsin Tobacco Quit Line coach before they leave the Salvation Army. Salvation Army staff develop an incentive strategy that they can sustain long-term, such as extra food pantry access, to promote participant connections with Quit Line treatment. These incentives are designed to give participants who want to quit using tobacco someday a reason to act on that desire today and to give staff more confidence that they can interest participants in talking with the Quit Line. This application represents our commitment at UW-CTRI to address socioeconomic disparities in tobacco use and access to tobacco treatment through partnerships with community service, healthcare and other organizations. September 2024-September 2030. Total budget over six years of $6.1 million if fully implemented. UG3/UH3 Funded by the National Cancer Institute. Dr. Danielle McCarthy, PI.
8. Genes, Neighborhoods and Alcohol Misuse from Adolescence to Mid-adulthood in the Add Health Study. The project involves secondary analyses of data from the landmark National Longitudinal Study of Adolescent to Adult Health (Add Health), a study that has prospectively followed 20,745 adolescents since 1994-95. The aim is to gain a better understanding of the link between the neighborhood in which one lives (e.g. whether one lives in a rural or urban community, in an area that is more or less disadvantaged) and alcohol involvement over the life course. The results of this study might support the development of neighborhood-level preventive and treatment interventions and might also suggest who would be especially aided by such interventions.
   September 2024-September 2028. Total budget over three years of $944,664. R01 Funded by NIAAA, Dr. Wendy Slutske, PI.
9. UW-CTRI Outreach Program–JUUL Settlement. This grant from the Wisconsin Department of Health Services Commercial Tobacco Prevention and Treatment Program aims to help young adults (ages 18-24) quit vaping. UW-CTRI will develop a brief, scalable, online single-session intervention to help young adults quit vaping. This includes “selfie” videos by young adults who vape(d) to share their stories and advice in a user-friendly format. Young adults will influence the intervention content and presentation via focus groups and user-centered design principles. The primary outcomes will be engagement with the intervention as well as changes in key attitudes, beliefs, and behavioral intention about quitting vaping. Karen Conner and Chris Hollenback coordinate aspects of these efforts. January 2024-December 2026, $386,000. Funded by the Commercial Tobacco Prevention and Treatment Program (CTPTP) of the Wisconsin Department of Health Services (WI DHS). Dr. Jesse Kaye, PI.
10. R35 Outstanding Investigator Award. This seven-year grant will empower UW-CTRI to identify and disseminate effective, innovative ways to help cancer patients quit smoking. Specifically, UW-CTRI researchers, led by grant PI Dr. Michael Fiore and Co-I Danielle McCarthy, will further evaluate innovative approaches to helping cancer patients who smoke to quit. They’ll advance knowledge regarding interventions and health-system changes that will support more patients living with cancer to break free from tobacco dependence. Research studies supported by this grant will identify effective interventions to help people with cancer quit smoking for good, as well as efficient and equitable ways to connect cancer patients with such treatments. UW-CTRI will work with diverse cancer-care programs across the nation to assist with implementing evidence-based smoking treatment for patients living with cancer. They’ll develop guides to disseminate the best strategies to cancer centers nationwide, such as the Tobacco Treatment Roadmap. The team worked with the American College of Surgeons and the Commission on Cancer to develop a new smoking cessation standard requirement for community cancer centers nation-wide beginning in 2026. UW-CTRI Researcher Mark Zehner and Mara Minion will manage the projects. December 2022-December 2029, $6.5 million. Funded by the National Cancer Institute. Michael Fiore, PI.
11. Motivating Change in Aging People Who Smoke. This K23 award funds a research study to increase smoking cessation in adults aged 50 and older. While these adults smoke at lower rates (8.2%) than the general population (13%), their cessation rates are also lower, in part because they are less likely to be advised to quit or offered help by providers. A common misperception is that mature adults can’t or won’t quit and, if they do, they won’t benefit from it. But the research reflects the contrary. When they do try to quit, they’re generally more successful than younger people, especially when they use evidence-based treatments (which double their success). The study runs qualitative interviews to look at what might motivate older adults to quit. One potential incentive is pointing out that quitting smoking can reduce risk for cognitive decline—commonly cited as the greatest fear among mature adults, but one yet to be used for motivation with smoking cessation. UW-CTRI recruits participants via signs, posters, calls from each person’s clinic and a letter to motivate and offer treatment. Researchers compare that to a clinic with no message and a clinic with a standard motivational method. The group plans to run the study at three clinics in the same health system. They’ll be tuned into any behavioral health symptoms and the socioeconomic status of the participants to better analyze and interpret results. Drs. Megan Piper, Carey Gleason, Jane Mahoney and Jessica Cook are serving as co-mentors to Principal Investigator Dr. Adrienne Johnson. May 2021-Feb 2026, $782,000. Funded by the National Institute on Aging of the National Institutes of Health. Dr. Adrienne Johnson, PI.
12. At EASE Study: Although the VA Healthcare System offers nicotine replacement therapy (NRT) to veterans not ready to quit, NRT only weakly affects long-term abstinence. Varenicline shows promise as a treatment for people who are not ready to quit but has never been compared with NRT and has not been evaluated among Veterans. The goal of this study is to evaluate whether varenicline is especially effective and cost-effective relative to NRT in Veterans who are willing to reduce but not quit smoking. This two-group randomized controlled trial will enroll 400 adults from three geographically diverse VA hospitals who do not want to quit smoking in the next 30 days but are willing to cut down. Participants will be randomized to one of two 12-week treatment groups: (1) varenicline, or (2) NRT (2 mg mini-lozenges). All participants will receive four phone counseling sessions focused on smoking reduction during the 12-week MPT. Any participants who decide to try quitting during the first 24 weeks of the study can request cessation treatment involving continued use of their assigned study medication and cessation counseling. The study team collaborates with participating VAs in Madison, Durham, Minneapolis and San Diego as well as the VA National Tobacco Use Treatment Program Office. January 2025-December 2029. $2.7 million. Merit Award funded by the US Department of Veterans Affairs, NIH. Dr. Jess Cook and Dr. Neal Doran, MPIs.

For a live look at current UW-CTRI Studies, click here.