New Studies

In the first half of 2025, UW-CTRI had two new studies and nine other active studies. Here are the new studies:

1. 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.
2. Options 2 Study. (A Randomized Comparative Effectiveness Trial of Nicotine Pouches for Cigarette Substitution: A Question of Public Health) UW-CTRI will test 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 will 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 will enroll 300 adults who smoke daily and are not planning to quit in the next 30 days. Participants will be 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) will be asked to use them for four weeks, an initial experimentation week, and then for a three-week switching trial where they will be 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 will come to the clinic following overnight abstinence and will 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 will 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 will 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.