UW-CTRI Launches Study Offering 3 Medications to Each Participant

From left: Dave Fraser, Madeline Oguss, McKenzie Hensen, and Paul Kohn are among the UW-CTRI staff members working on the new “3 Medications Study” to help participants quit smoking.

UW-CTRI is recruiting patients for a new pilot study that offers 3 quit-smoking medications to every participant (with no placebo). Funded by an R35 grant from the National Cancer Institute to UW-CTRI Director Dr. Michael Fiore and facilitated by UW-CTRI Director of Research Administration Dave Fraser (left), this study pilots a potentially powerful combination of two of the most effective pharmacotherapies: varenicline (Chantix) plus combination nicotine replacement therapy (NRT).

In one UW-CTRI study, varenicline had a quit rate of 43.6% compared to placebo (Jorenby et al, 2006). In a separate UW-CTRI study, offering the nicotine patch + nicotine gum for 6 weeks along with coaching from the Wisconsin Tobacco Quit Line yielded quit rates of 51.6% (Smith et al, 2013). While varenicline is intended to block nicotine from reaching receptors in a smoker’s brain, the medicine does not block all nicotine from the brain. In the long run, researchers are interested in discovering whether combining varenicline with combination NRT and coaching will help patients quit smoking by both blocking nicotine cravings and withdrawal as well as tamping the stimulation the drug provides. The purpose of the pilot study is to better determine the type and frequency of assessments required to manage any medication side effects.

Data from this pilot study will help inform the design of future studies that would use this combination treatment as a cessation tool within the chronic care arsenal of treatments. This is part of a larger effort of innovation to help health-care systems assist smokers who may need more intensive treatments for smokers who have failed to quit with other methods.

The pilot study will recruit 40 participants. The research team has already recruited more than 130 volunteers via Facebook advertising. UW-CTRI Researcher Dr. Kristin Berg will also serve as a study physician along with Dr. Fiore. UW-CTRI Admin Specialist Madeline Oguss is also working on helping set up the study, and staff member McKenzie Henson is contacting participants and managing logistics on the days the study will have visits. Paul Kohn developed the study database.