Active Studies

UW-CTRI has nine active studies and one new study. Here are the active studies.

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1. Breaking Addiction to Tobacco for Health 2 (BREATHE 2). (Status: Recruiting) In a first, researchers at the University of Wisconsin are comparing the most effective treatments to help people quit smoking in real-world clinics, with a goal of tailoring and optimizing help to individual smokers. Under the direction of Drs. Timothy Baker and Michael Fiore, UW-CTRI is partnering with health systems to treat more than 4,000 clinic patients. They’re reaching out to patients listed as smokers in electronic health records to help those who are ready to quit and motivate those who aren’t. The innovative experiment will be the first to experimentally compare the two most effective interventions available—varenicline (Chantix) vs. combination nicotine-replacement medications—and determine whether they are enhanced by type of counseling (in-person vs. phone), or by extra medication before quitting or after the standard treatment. About 25 million smokers in America make a primary care visit each year, but only about five percent of smokers who try to quit use the cessation counseling and medication we know can help. In this study, the research team will reach out to them and offer these treatments. May 2019-May 2024, $12.5 million. Funded by NCI. Drs. Timothy Baker and Michael Fiore, PIs.

2. VA Merit Grant. (Status: Recruiting) The US Department of Veterans Affairs awarded a grant to UW-CTRI Researcher Dr. Jessica Cook and the William S. Middleton Memorial Veterans Hospital (VA) in Madison to be the first ever to evaluate a chronic care system designed to help Veterans who are both ready and not ready to quit smoking. Many Veterans become addicted to tobacco during their military service. Led by Cook, the team is implementing the grant at the VA, offering telemedicine visits for all Veterans who smoke, including rural Veterans who cannot afford to drive into Madison for visits. It’s a way of giving back to Veterans who have sacrificed so much for our country by assisting those who need it most. The Enhanced Chronic Care system provides ongoing motivational interventions and interpersonal support to Veterans who use tobacco but are not ready to quit. The treatment is designed to encourage Veterans to use evidence-based tobacco treatment and to ultimately help them quit. Cook works with UW-CTRI colleagues Elana Brubaker and Kirsten Webster to recruit 250 Veterans who smoke to receive the Enhanced Chronic Care intervention, and another 250 to receive the Standard Care (brief advice to quit once per year). The researchers hope this study will help identify an effective smoking treatment strategy for VA clinical practice. January 2019-December 2023, $1 million. Funded by the VA. Dr. Jess Cook, PI.

3. Options Study. (Status: Set to recruit) People in the Madison and Milwaukee areas who want to see what it’s like to temporarily switch from just smoking to alternative products—like Juul e-cigarettes or cigarettes with very low nicotine content—can give it a try in a new research study. They can even get paid up to $380 for doing it. All study participants will be smokers who are willing to try quitting smoking for a week and try something new for just that week. They will:

• Be randomly assigned to switch to either vaping or smoking low-nicotine cigarettes (LNC) for a week, or to using no alternative product.
• Then they go back smoking for a week.
• Next, they switch from smoking to Juul, or LNC or no alternative product.
• During the two switch weeks, all participants will be given patches. During one week, the patches will have active nicotine and, during the other switch week, the patches will be placebo (no nicotine).

Researchers will examine how well Juul or low-nicotine cigs can substitute for regular smoking, and how nicotine patches factor into it and why. The landscape of tobacco products is changing and researchers want to understand how people use these products and how they compare to their regular cigarettes. The researchers hope that this information will help inform the FDA as they try to make rules about tobacco products. May 2019-April 2022, $1.4 million. Funded by NCI and FDA. Dr. Megan Piper, PI.

4. Quitting Using Intensive Treatments Study (QUITS). (Status: Recruitment complete, seeing patients in follow-up) UW-CTRI is partnering with the UW Department of Medicine Cardiology Division on the study. Participants in Madison and Milwaukee get free medication and coaching. All patients get three months of varenicline pills and coaching; some patients also get nicotine patches and extended medications regimens. The study is designed to answer two key questions: 1) whether adding the nicotine patch to varenicline (Chantix) can boost quit rates; and 2) whether extending varenicline or varenicline + nicotine patch treatment for six months (rather than the standard three months) can boost quit rates. Researchers expect both treatment enhancements (either adding the nicotine patch or extending treatment for 6 months) will yield higher cessation rates among people trying to quit. Smokers and their clinicians are calling for cessation treatment options that can substantially increase current modest quit rates, and the goal of this study is to produce such an enhancement. June 2017-May 2021, $7 million. Funded by NHLBI. Drs. Timothy Baker and James Stein, PIs.

5. Transforming the Treatment of Tobacco Use in Health Care: Seizing the Potential of the Electronic Health Record (EHR) to Deliver Comprehensive Chronic Care Treatment for Smoking. (Status: Several projects ongoing) This R35 grant to Dr. Michael Fiore is designed to offer flexibility to researchers in the quest to overcome barriers in helping primary-care patients quit smoking. In other words, it sparks innovation to translate efficacious treatments into clinical use. Projects have included:

• Tobacco Cessation Quitline eReferral. This study is a two-group, non-blinded, randomized, controlled trial to assess the impact of an EHR-based eReferral system relative to the current standard Fax referral method. UW-CTRI partnered with Ascension WI-Wheaton Franciscan Healthcare and Gundersen Health System on the clinical trial to test eReferrals versus fax referrals. The trial, known as the Quit Line Referral Method Study, included 23 clinics, a dozen from Wheaton Franciscan Healthcare and 11 from Gundersen Health System. In each system, half of the clinics tested the closed-loop, HIPAA-compliant eReferral to the Quit Line, while the others operated the Fax to Quit program. Across both healthcare systems, eReferral produced referral rates that were 3-4 times higher than those produced by Fax to Quit. While the rates improved, challenges include increasing enrollment rates as well as sustaining use outside of a research study. A main outcomes paper was published in the Journal of the American Medical Informatics Association.
• SmokefreeTXT Pilot. This pilot project integrates NCI’s SmokefreeTXT program that sends text messages to participants’ phone to inspire and support an attempt to quit smoking. At two participating Gundersen Health System clinics, if a patient was ready to quit smoking, the “best practice alert” in electronic health records (EHR) prompted clinicians to refer to SmokefreeTXT via an eReferral order. Data from this small pilot study indicated feasibility of the approach, and present questions on which members of a care team may be best suited to intervene with this approach. Based on study findings, researchers reported in a paper in Translational Behavioral Medicine that interoperable eReferral via outpatient EHR to SmokefreeTXT was feasible and acceptable to clinic staff, enrolled roughly 3% of smokers, and the individual clinic context and implementation approach may influence reach.
• Tolerability of 3 Medications for Smoking Cessation. A single-group, open-label, pilot study of 37 patients explored the tolerability and feasibility of combining varenicline with combination nicotine-replacement medications. An innovative “triple therapy” of three FDA-approved medications taken together—along with coaching on how to quit smoking—appears safe and shows promise, according to a UW-CTRI research paper published in the Journal of Smoking Cessation.
• Comprehensive Chronic Care Smoking Treatment System. Given that only about half of smokers in America are advised to quit during clinic visits, UW-CTRI has teamed with Epic and GHC-SCW in a program designed to reach out to all GHC patients who smoke. GHC Tobacco Cessation Outreach Specialists Katherine Coates and Hannah Wallenkamp are ensuring their patients have the tools they need to quit smoking for good. All six GHC primary-care sites are actively participating in this project.
• Tablet Technology Pilot Project with Low-Income Smokers. A tablet-based smoking-cessation intervention for clients was pilot tested at two Salvation Army sites. The goals were to gauge integration and scalability of technology-assisted interventions and to reach out to potential treatment-delivery sites that serve populations who smoke at a higher rate. Following the intervention, researchers interviewed staff and clients about their experiences, affirming acceptability of the tablet intervention.
• Learn, Connect, and Quit. Researchers conducted a pilot of a tablet app featuring videos for smokers visiting one primary-care clinic. Unfortunately, clinic staff gave the tablet to patients much less frequently than researchers anticipated. Of the 30 patients who engaged with the app, 15 watched at least 1 video: 10 watched 1 video, 3 watched 2 videos and 2 watched 3 videos.
• Financial Incentives for Smoking Treatment Engagement. Building upon the robust treatment program implemented at Group Health Cooperative-South Central Wisconsin (GHC), this project will evaluate modest financial incentives to smokers who engage in quit planning with the GHC Tobacco Cessation Outreach Specialists. Five-hundred 50 smokers will be randomized to three different incentive levels to encourage engagement in quit-smoking treatment planning over the phone. Researchers will evaluate ads promoting a $20 wellness reward for speaking to the specialists.

August 2015-July 2022, $6.1 million. Funded by the National Cancer Institute of the National Institutes of Health. Dr. Michael Fiore, PI.

6. Improving Quitline Support Study (IQS). (Status: Recruiting participants) This project will evaluate promising strategies to enhance quit-smoking success among low-income smokers. Researchers are enrolling 1,408 Medicaid-eligible or uninsured smokers who continued smoking four months after engaging in standard services from the Wisconsin Tobacco Quit Line. These smokers are invited to participate in an experiment to evaluate the value of augmenting standard Quit Line treatment with more intensive counseling, more intensive nicotine replacement, NCI’s SmokefreeTXT text support program, and/or financial incentives for using Quit Line and SmokefreeTXT support. Analyses will examine the main and interactive effects of these four treatment components at 26 weeks, as well as other quit-smoking outcomes in this at-risk population. August 2017-July 2022, $3 million. Funded by the National Cancer Institute of the National Institutes of Health. Drs. Danielle McCarthy and Michael Fiore, PIs.
7. First Breath Families: Helping Low-Income Moms Quit Smoking and Babies Grow Up Smoke-Free. (Status: Assisting with implementation) The Wisconsin Women’s Health Foundation (WWHF) has received a $1 million grant from the Wisconsin Partnership Program to significantly expand efforts to bring quit-smoking services to high-risk individuals, families and communities across Wisconsin. UW-CTRI is collaborating with WWHF on this project, to be provided during five years to First Breath Families. The group will also seek systems changes that will provide sustainable funding for these services. The First Breath Families team will collaborate with local agencies that serve pregnant and postpartum women and their families, provide statewide access to local WWHF Quit Coaches, and develop participant-informed services. January 2018-December 2022, $1,000,000. Funded by the Wisconsin Partnership Program/Oversight & Advisory Committee (WPP/OAC). Drs. Bruce Christiansen and Michael Fiore, Academic Partners. Lisette Kahlil, Wisconsin Women’s Health Foundation Community Lead.
8. Smoking Cessation for those with Mental Illness – the Bucket Approach Training. (Status: Dissemination) UW-CTRI Researcher Dr. Bruce Christiansen collaborated with UW-CTRI colleagues to create an online training based on the “Bucket Approach” to help patients with serious or significant mental illness to quit smoking. This online training is offering free continuing education credits via the same UW training site that already offers a general training for behavioral health providers on how to help behavioral health patients quit smoking. The focus for the training is on reaching out to Wisconsin Community Support Programs (CSP) and Comprehensive Community Services (CCS) Systems. CSPs work with patients with serious mental illness typically at discrete treatment sites. CCSs generally treat patients with less-serious but still significant mental illness using network models. Both types of programs are county-based. Currently activities are supporting the implementation of the Bucket Approach in treatment programs. These activities include: dissemination by the UW-CTRI outreach staff; Bucket Approach Integration Awards to treatment programs to implement the Bucket Approach; videos of clients and therapists talking about the quitting journey; and the creation of rolls for Certified Peer Specialists to help peers reduce and quit. October 2018-September 2021, $456,000. Funded by the State of Wisconsin Department of Health Services. Dr. Bruce Christiansen, PI.

9. Cardiac and LUng E-cigarette smoking Study (CLUES). The UW Atherosclerosis Imaging Research Program (UW AIRP) and UW-CTRI are collaborating on a study on the acute and chronic effects of vaping and dual use of cigarettes and e-cigarettes. UW-CTRI is collaborating on the project. The project is led by UW AIRP Director and Cardiologist Dr. James Stein and UW-CTRI Director of Research Dr. Tim Baker. The study is enrolling 440 participants representing four groups: vapers, smokers, dual users, and never users. Participants receive $200 for two study visits. The study uses an array of tests to explore relations between:

• Acute smoking and/or vaping with possible cardiovascular and pulmonary disease mechanisms.
• Longer-term patterns of smoking and/or vaping with measures of cardiovascular and pulmonary dysfunction and injury.

These outcome biomarkers will predict future disease risk and measure injury to arteries and lungs. For cardiovascular disease (CVD), the primary biomarkers are brachial artery flow-mediated dilation (FMD, a measure of endothelial function that predicts CVD) and carotid intima-media thickness (IMT, a measure of subclinical arterial injury and atherosclerosis that also predicts CVD events). For pulmonary disease, the primary biomarkers are predicted lung volumes and flow rates obtained by spirometry. In secondary analyses, researchers will:

• Characterize carotid artery echogenicity (a novel measure of arterial injury).
• Perform treadmill exercise stress testing (to measure exercise capacity, heart rate recovery, heart rate reserve, and rate-pressure product).
• Electrocardiography (to measure heart rate variability).
• Measure blood pressure, fasting lipids, HbA1c, markers of inflammation and oxidation (leukocyte count, C-reactive protein, F2 isoprostanes), and exhaled nitric oxide. These tests index the degree of dysfunction, injury mechanisms, and future risks of cardiovascular and pulmonary disease.

UW-AIRP Manager Dr. Claudia Korcarz coordinates the study and UW-CTRI Director of Clinical Services Dr. Doug Jorenby serves as the on-site and operational scientific lead. Dr. Nathan Sando is overseeing all pulmonary measurements. UW-AIRP Research Specialist Kristin Hansen will assist with tests. Holly Prince of UW-CTRI is managing study visits in Madison. September 2018-August 2022, $1.8 million. Funded by NIH. Drs. Timothy Baker and James Stein, PIs.