UW-CTRI has 6 active studies and 1 new study. Here are the active studies.
Quitting Using Intensive Treatments Study (QUITS). (Status: Recruiting and seeing patients) This study began recruiting pilot patients in fall 2017 and began full recruitment January 2018 in the Madison and Milwaukee areas. UW-CTRI is partnering with the UW Department of Medicine Cardiology Division on the study. Participants will get free medication and coaching, thanks to a $7 million four-year grant from the National Heart, Lung, and Blood (NHLBI) Institute to UW-CTRI and the UW Department of Medicine.
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. All participants will receive coaching to quit smoking.
“We 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,” said UW-CTRI Research Director Dr. Tim Baker. “Smokers and their clinicians are calling for cessation treatment options that can substantially increase our current modest quit rates, and we believe the proposed enhancements will do just that.” June 2017-May 2021, $7 million. Funded by NHLBI. Drs. Timothy Baker and James Stein, PIs.
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 study, funded by a R35 grant to Dr. Michael Fiore, is designed to overcome barriers to effective treatment of smokers in the primary-care setting. This research is intended to develop and apply innovative, efficient, and powerful research methods to translate efficacious treatments into clinical use. Projects have included:
Project 1a. 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 concluded in Year 3. 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.
Project 1b. 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 the 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.
Project 2. 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. Researchers completed final follow-up assessments and data analyses. See page 2 above for the manuscript published by the Journal of Smoking Cessation.
Project 3. 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. They reach out:
- At least annually to all GHC patients identified as smokers, with an invitation to receive cessation help, even if they don’t visit the clinic.
- Within a week after clinic visits in which patients neither addressed nor endorsed willingness to quit at that time.
- Three times to patients who are making a quit attempt and at least once to patients attempting to reduce their smoking, with potential to offer ongoing reduction-goal support calls as requested.
All six GHC primary-care sites are actively participating in this project.
- Project 4. Tablet Technology Pilot Project with Low-Income Smokers. In order to continue to test the 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, IRB approval was obtained for a tablet-based smoking-cessation intervention for clients at two Salvation Army sites. Following the intervention, staff and clients were interviewed about their experiences, receiving the intervention via a tablet.
August 2015-July 2022. $6.1 million. Funded by the National Cancer Institute of the National Institutes of Health. Dr. Michael Fiore, PI.
Exhale Study. (Status: Retention and long-term follow-up) 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 is providing 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 have identified and are tracking over time 150 participants who exclusively smoke cigarettes and 250 participants who both smoke and vape. Researchers have 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 is providing 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.
Breaking Addiction to Tobacco for Health (BREATHE). (Status: Recruitment complete; seeing patients) UW-CTRI has received a $12 million 5-year grant from the National Cancer Institute of the National Institutes of Health. The grant will fund research designed to test new phased-based treatments to help patients in the Milwaukee and Madison areas quit smoking. Partners in this research include 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 visits a participating clinic, regardless of the initial reason for the visit, is invited to get treatment through BREATHE. This study implements both an electronic health records (EHR) system that increases smokers’ recruitment into treatment as well as a highly effective chronic-care treatment with intervention components for all smokers. First, the EHR system will be implemented in 18 clinics in 2 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 will experimentally compare multiple intervention components and identify especially effective interventions for every phase of smoking treatment. This package of components will: increase quitting motivation amongst smokers initially unwilling to quit and prepare them for cessation (Project 2), enhance quitting success and prevent relapse when smokers are ready to quit (Project 3), and re-engage relapsed smokers in treatment and restore their abstinence (Project 4). Our highly integrated research projects will thus implement a powerful new EHR strategy to efficiently recruit primary-care patients who smoke into chronic-care treatment. BREATHE researchers will combine data from all projects and produce an optimized, comprehensive, chronic-care treatment for smoking that can be readily implemented in primary care settings by project end. Thus, this research will simultaneously advance both smoking treatment and treatment research methods. June 2014-July 2019, $12 million. Funded by the National Cancer Institute of the National Institutes of Health. Michael Fiore and Tim Baker, PIs.
PTSD and Veterans Merit Award. (Status: Recruitment complete) UW-CTRI Researcher Dr. Jessica Cook leads this merit award research at the William S. Middleton Memorial Veterans Hospital in Madison, Wisconsin. The primary objective of this research is 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. PTSD is highly prevalent in the VA patient population and is associated with a rate of smoking (53% – 66%) that far exceeds that of VA enrollees in general (22%). PTSD is also associated with unusually high rates of failure to quit smoking. The disparity in smoking-cessation outcomes amongst veterans with PTSD may occur because standard smoking-cessation treatment does not address PTSD-specific vulnerabilities. Veterans with smoking-PTSD comorbidity may respond better to treatment that addresses their PTSD and associated affective symptoms, because such symptoms can both reinforce smoking and undermine quit attempts. Recent evidence shows that behavioral activation therapy (BA), a behavioral treatment that increases engagement in reinforcing activities, significantly reduces PTSD symptoms. BA may improve smoking cessation outcomes amongst veterans with PTSD because it reduces overall PTSD symptom severity and affective distress (low positive affect, high negative affect), which can cause smoking relapse. The funded research will 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 is intended to constitute a credible intervention that controls for contact time. Secondary objectives are to determine if BA improves PTSD symptomatology and associated affective distress, and to identify potential mediators of BA on smoking outcomes. A total of 120 veterans with PTSD who are motivated to quit smoking will attend an initial diagnostic and baseline assessment session. Those who are interested, eligible, and who provide consent will be randomly assigned to receive ST+BA or ST+HSE and will be contacted by their individual study therapist to schedule the first treatment session. Participants will be stratified into treatment groups based on: 1) Major depressive disorder (MDD; present versus absent), and 2) PTSD symptom severity. All participants will receive eight individual sessions of ST+BA or ST+HSE. All participants will receive 20 minutes of identical standard smoking cessation treatment in each of the eight sessions. Those in the ST+BA condition will receive an additional 30 minutes of behavioral activation therapy; those in the ST+HSE condition will receive an additional 30 minutes of health education and information about smoking. All participants will receive 8 weeks of the nicotine patch. Smoking-cessation outcomes will be assessed 2, 4, 8, 16, and 26 weeks after the quit date. This research has important clinical and public health significance because smoking is especially common among veterans with PTSD, and it is the leading preventable cause of disease and disability. Reducing smoking rates among veterans with PTSD would result in substantially lower smoking-related illness and death in this vulnerable group of smokers. It would also reduce tobacco-related health-care costs charged to the VA. The grant will support a researcher and a study counselor. Jan. 2014-Sept. 2019, $770,500. Funded by the United States Department of Veterans Affairs. Jessica Cook, PI.
Genetically Informed Smoking Cessation Trial. (Status: Recruiting patients) This randomized clinical trial is 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 hope 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 suggests that the nicotinic receptor gene CHRNA5 alters the response to NRT, has been replicated in a meta-analysis. This study of 720 smokers uses a stratified randomization trial design based on a subject’s pertinent genotype for smoking cessation. Specifically, in Aim 1, researchers will determine if CHRNA5 genotype moderates the effect of medication (combination NRT, varenicline, vs. placebo) on abstinence. In Aim 2, researchers will determine if CHRNA5 genotype predicts medication adherence and side effects. In Aim 3, researchers will incorporate 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.
Improving Quitline Support Study (IQS). (Status: Recruiting participants) Over the past five decades, overall smoking prevalence has fallen, but socioeconomic disparities in tobacco use and its burden have grown substantially. Prevention and treatment advances have disproportionately benefited more advantaged smokers. This project will evaluate promising strategies to enhance quit-smoking success among low-income smokers. The project will enroll 1,408 Medicaid-eligible or uninsured smokers who have recently enrolled in the Wisconsin Tobacco Quit Line, but who report continued smoking four months after engaging in standard Quit Line services. These smokers will be invited to participate in an experiment that will 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.
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. Tobacco use during pregnancy remains one of Wisconsin’s leading preventable causes of poor birth outcomes and, in some communities, up to one-in-three women smoke during pregnancy. 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.
Smoking Cessation – Bucket Approach Training Module Development. (Status: Developing online training) UW-CTRI Researcher Dr. Bruce Christiansen has been awarded a one-year grant from the Wisconsin Department of Health Services to create an online training based on his “Bucket Approach” to help patients with serious or significant mental illness to quit smoking. Since behavioral health practitioners are busy people, the Bucket Approach is concrete, easy to follow, and brief to implement. Christiansen will collaborate with UW-CTRI Communications Director Chris Hollenback to create videos for the online training, which will offer Continuing Education Credits via the UW training site that training for behavioral health providers on how to help all behavioral health patients quit smoking. The focus for the new training will be 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. The Bucket Approach is designed to tailor the intervention to various motivational statuses of patients with serious mental illness. October 2018-September 2019. $112,000. Funded by the State of Wisconsin Department of Health Services. Dr. Bruce Christiansen, PI.