OVERVIEW: This report constitutes the third in a series of twelve-month updates on UW-CTRI research. These reports, released by the UW-CTRI Communications Office, summarize published and in-press manuscripts, as well as new and ongoing grants, contracts and other research projects. Also, on page 15 of this report, we provide a financial summary for UW-CTRI for 2012.
SUMMARY: In 2012, the UW-CTRI research team produced:
30 published papers
3 papers in press
9 active studies
4 new studies
4 studies recently completed
THANK YOU: UW-CTRI is grateful to its partners, the UW Department of Medicine, the UW School of Medicine and Public Health, the Wisconsin Department of Health Services, NIH, CDC, Robert Wood Johnson Foundation, and the Wisconsin Partnership Program.
Note: Names in bold are current UW-CTRI employees.
Baker TB, Piper ME, Schlam TR, Cook JW, Smith SS, Loh W-Y, Bolt DM. Are Tobacco Dependence and Withdrawal Related Amongst Heavy Smokers? Relevance to Conceptions of Dependence. Journal of Abnormal Psychology. 2012 Nov;121(4):909-21.
Summary: Dependence and withdrawal measures are meaningfully related and their shared variance is associated with cessation likelihood; there are clear differences between craving and withdrawal symptoms; both craving and withdrawal symptoms are strongly related to a pattern of regular smoking. These findings support models that accord an important role for associative processes and withdrawal symptoms, especially craving, in drug dependence. The findings also support the use of withdrawal variables as criteria for the evaluation of dependence measures.
Chen L-S, Baker TB, Piper ME, Breslau N, Cannon DS, Doheny KF, Gogarten SM, Johnson EO, Saccone NL, Wang JC, Weiss RB, Goate AM, Bierut LJ. Interplay of Genetic Risk Factors (CHRNA5-CHRNA3-CHRNB4) and Cessation Treatments in Smoking Cessation Success. American Journal of Psychiatry. 2012;169(7):735-42.
Summary: Researchers examined the genetic variants in the CHRNA5-CHRNA3-CHRNB4 region that predict nicotine dependence. Smokers with the high-risk haplotype were three times as likely to respond to pharmacologic cessation treatments as were smokers with the low-risk haplotype. The high-risk haplotype increased the risk of cessation failure, and this increased risk was ameliorated by use of quit-smoking medications. By identifying a high-risk genetic group with heightened response to smoking meds, this work may support the development of personalized cessation treatments.
Fraser D, Baker TB, Fiore MC, Adsit RA, Christiansen BA. Electronic Health Records (EHR) as a Tool for Recruitment of Participants in Clinical Effectiveness Research: Lesson Learned from Tobacco Cessation. Translational Behavioral Medicine. [Epub ahead of print].
Summary: This paper describes the accomplishments and lessons learned from a translational (clinic/research) approach to the development of an EHR tool for participant recruitment and clinic engagement in tobacco cessation research. Patients identified as tobacco users can be seamlessly linked to the study by the primary care team prompted by the EHR with minimal physician or staff time. The patient need not be motivated to quit immediately in order to begin the intervention. When building the EHR, communication among all stakeholders is key.
Hockenberry JM, Curry SJ, Fishman PA, Baker TB, Fraser DL, Cisler RA, Jackson TC, Fiore MC. Health Care Costs During the Period Surrounding Smoking Cessation. American Journal of Public Health. June 2012;42(6):596–601.
Summary: The inclusion of smoking-cessation therapy does not appear to raise short-term health-care costs. By the sixth quarter post-quit, sustained quitters were less costly than trial participants who continued smoking.
Cook JW, Fucito L, Piasecki TM, Fleming M, Piper ME, Schlam TR, Berg K, Baker TB. Relations of Alcohol Consumption With Smoking Cessation Milestones and Tobacco Dependence. Journal of Consulting and Clinical Psychology. 2012 Dec;80(6):1075-85.
Summary: Alcohol consumption pattern was significantly associated with initial cessation and lapse, and these findings remained after controlling for the effects of treatment, race, gender, and cigarettes per day. Relative to moderate drinkers, both non/infrequent drinkers and binge drinkers were less likely to achieve initial cessation, and binge drinkers were more likely to lapse. Non/infrequent drinkers’ smoking cessation difficulties may be particularly related to core features of tobacco dependence, whereas binge drinkers’ difficulties may be related to environmental and social influences.
Leventhal AM, Japuntich SJ, Piper ME, Jorenby DE, Schlam TR, Baker TB. Isolating the Role of Psychological Dysfunction in Smoking Cessation Failure: Relations of Personality and Psychopathology to Attaining Smoking Cessation Milestones. Psychology of Addictive Behaviors. [Epub ahead of print.]
Summary: Psychopathology did not predict any outcome when controlling for personality. Negative emotionality showed the most robust and consistent effects, significantly predicting failure to initiate abstinence, earlier lapse, and lower point-prevalence abstinence rates. Substance use disorder and constraint did not predict cessation outcomes. These findings suggest that personality-related manifestations of internalizing dysfunction are more accurate markers of affective sources of relapse risk than mood and anxiety disorders.
Guzmán A, Walsh MC, Smith SS, Malecki KC, Nieto FJ. Evaluating the Effects of Statewide Smoking Regulations on Smoking Behaviors Among Participants In the Survey of the Health of Wisconsin (SHOW). Wisconsin Medical Journal. 2012 Aug;111(4):166-71.
Summary: This study evaluated effects of the 2009 Wisconsin statewide smoking ban enacted in July 2010, among participants in the Survey of the Health of Wisconsin (SHOW). The smoking ban was associated with a reduction of participants reporting exposure to smoke outside the home (from 55% to 32%) and at home (13% to 7%). The new legislation was associated with an increased percentage of participants with no-smoking policies in their households (from 74% to 80%). The results were stronger among participants who were older, wealthier, and more educated.
Schlam TR, Piper ME, Cook JW, Fiore MC, Baker TB. Life One Year After a Quit Attempt: Real-Time Reports of Quitters and Continuing Smokers. Annals of Behavioral Medicine. 2012 Dec;44(3):309-19.
Summary: Smokers often say they light up because they’re stressed, and are reluctant to quit because they fear long-lasting withdrawal. However, this study shows that—one year after quitting—former smokers have much less craving and restlessness than those who kept smoking. Former smokers are also less stressed than when they smoked. Patients who quit smoking, on average, reported no significant craving a year later. These former smokers’ lives improved with: 1) fewer days with stressful events; 2) less restlessness and anger/irritability; 3) sizeable reductions in craving.
Smith SS, Keller PA, Kobinsky KH, Baker TB, Fraser DL, Bush T, Magnusson B, Zbikowski SM, McAfee TA, Fiore MC. Enhancing Tobacco Quitline Effectiveness: Identifying a Superior Pharmacotherapy Adjuvant. Nicotine & Tobacco Research. First published online: Sept. 19, 2012.
Summary: Smokers who called the national tobacco quitline (1-800-QUIT-NOW) and received a combination of medications quit at much higher rates. Offering callers the nicotine patch plus nicotine gum and four counseling calls helped half the callers quit smoking. That’s about a 10 percentage point improvement over offering just a single nicotine medication along with other quitline services. Since more than 500,000 Americans call the national quitline each year, offering combination nicotine medications could help an additional 50,000 quit.
Christiansen BA, Reeder K, Hill M, Baker TB, Fiore MC. Barriers to Effective Tobacco Dependence Treatment for the Very Poor. Journal of Studies on Alcohol and Drugs. 2012 Nov;73(6):874-84.
Summary: Both race and income predicted beliefs and quitting-related variables independently and jointly. Continued tobacco-control progress requires addressing specific populations with known high tobacco use. One of these populations is those with low income. Efforts to engage them in treatment will have to address specific beliefs about smoking and quitting.
Schlam TR, Wilson NL, Shoda Y, Mischel W, Ayduk O. Preschoolers’ Delay of Gratification Predicts Their Body Mass 30 Years Later. Journal of Pediatrics. Aug. 18, 2012.
Summary: Longer delay of gratification at age 4 years was associated with a lower BMI 3 decades later. Identifying children with greater difficulty in delaying gratification could help detect children at risk of becoming overweight or obese. Interventions that improve self-control in young children have been developed and might reduce children’s risk of becoming overweight and also have positive effects on other outcomes important to society.
Sims TH, McAfee T, Fraser DL, Baker TB, Fiore MC, Smith SS. Quitline Cessation Counseling for Young Adult Smokers: A Randomized Clinical Trial. Nicotine and Tobacco Research. Oct. 18, 2012.
Summary: Relative to self-help, quitline counseling motivated young adults to set a quit date but abstinence rates were not improved. Research is needed on how to motivate young adult smokers to seek cessation treatment, including quitline services.
Carmody TP, McFall M, Saxon AJ, Malte CA, Chow B, Joseph AM, Beckham JC, Cook JW. Smoking Outcome Expectancies In Military Veteran Smokers With Posttraumatic Stress Disorder. Nicotine and Tobacco Research. 2012; 14(8):919-26.
Summary: The findings support the use of the SCQ-A as a valid measure of smoking outcome expectancies in military veteran smokers with PTSD. Moreover, they suggest that smoking outcome expectancies may play an important role in explaining the relationship between PTSD and cigarette smoking.
Piper ME, Cohen J, Consgrove K. 2012 SRNT Annual Meeting Summary. Nicotine and Tobacco Research. 2012;14(9):1003-5.
Summary: We need to accelerate addiction science and tobacco control research and do so in a transdisciplinary fashion. We need research in basic science, in clinical medicine, in policy, and in public health to employ the concept of disciplinary diversity in our research, from bench to bedside, and from bedside to community.
Zhang X*, Martinez-Donate AP, Kuo D, Jones NR. “How is Smoking Handled in Your Home?”: Agreement Between Parental Reports On Home Smoking Bans in the United States, 1995-2007. Nicotine and Tobacco Research. 2012; 14(10):1170-9. *TTS grantee.
Summary: Parental concordance on the existence of a home smoking ban increased from 1995 to 2007. This suggests estimates of home smoking bans based on just one parent may be more reliable now than they were in the past. Interventions to improve the adoption and enforcement of home smoking bans should target households with current smoker parents.
Piper ME, Rodock M, Cook JW, Schlam TR, Fiore MC, Baker TB. Psychiatric Diagnoses among Quitters Versus Continuing Smokers 3 Years After Their Quit Day. Drug and Alcohol Dependence. Sep. 17, 2012.
Summary: Quitting smoking does not appear to negatively influence mental health in the long-term and may be protective with respect to depression and substance use diagnoses; this should encourage smokers to make quit attempts and encourage clinicians to provide cessation treatment.
Piper ME, Baker TB, Mermelstein R, Collins LM, Fraser D, Jorenby DE, Smith SS, Christiansen BA, Schlam TR, Cook JW, Oguss M, Fiore MC. Recruiting and Engaging Smokers in Treatment in a Primary Care Setting: Developing a Chronic Care Model Implemented Through a Modified Electronic Health Record. Translational Behavioral Medicine. Oct. 2012.
Summary: The EHR prompted primary care clinic staff to invite patients who smoked to participate in a tobacco treatment program. Patients who accepted and were eligible were offered smoking reduction or cessation treatment. More than 65% of smokers were invited to participate, and 12.4% of all smokers enrolled in treatment—30% in smoking reduction and 70% in cessation treatment. The chronic care model developed for treating tobacco dependence, integrated into the primary care system through the EHR, has the potential to engage up to 4.3 million smokers in treatment a year.
Yeh VM, McCarthy DE, Baker TB. An Ecological Momentary Assessment Study of Pre-Quit Markers for Smoking Cessation Failure. Experimental Clinical Psychopharmacology. Aug. 27, 2012.
Summary: Smokers who quit on the quit day felt faster increases in negative mood preceding the quit attempt than did smokers who quit after the quit date (delayed quitters). Meanwhile, the negative-affect trajectories for delayed quitters did not differ from those who never quit smoking. These results suggest that quitters and continued smokers can be differentiated by specific dimensions of pre-quit craving and negative affect, but the effects hold only in certain circumstances.
Timms KP, Rivera DE, Collins LM, Piper ME. System Identification Modeling of a Smoking Cessation Intervention. Paper Published as Part of the 16th International Federation of Automatic Control Symposium on System Identification. 2012, Brussels, Belgium.
Summary: This paper uses intensive longitudinal data from a quit-smoking clinical trial to compare two analytic techniques: an engineering approach to understanding how a quit-smoking intervention works (system identification) vs. a more traditional statistical approach. It tests system identification as a way to describe how craving is influenced by quit-smoking interventions. We found that the two models differ in how they describe smoking resumption, and the case is made that the feedback mechanism more appropriately describes the relationship between craving and smoking during a cessation attempt.
Sheffer MA, Baker TB, Fraser D, Adsit RT, McAfee T, Fiore MC. Academic Detailing Increases Fax Referrals to a State Tobacco Cessation Quit Line: A Randomized Study. American Journal of Preventive Medicine. 2012;42(1):21–28.
Summary: Enhanced academic detailing, which included on-site training, technical assistance, and performance feedback, increased the number of quitline referrals more than fıvefold over a fax referral program implemented without such enhanced academic detailing.
Asthana A, Piper ME, McBride PE, Ward A, Fiore MC, Baker TB, Stein JH. Long-term Effects of Smoking and Smoking Cessation on Exercise Stress Testing: Three-Year Outcomes From a Randomized Clinical Trial. American Heart Journal. 2012;163:81-87.
Summary: Despite weight gain, smoking cessation leads to prolonged improvements in endothelial function, which may mediate part of the reduced cardiovascular disease risk observed after smoking cessation.
Baker TB, Breslau N, Covey L, Shiffman, S. DSM Criteria for Tobacco Use Disorder and Tobacco Withdrawal: A Critique and Proposed Revision for DSM-5. Addiction. 2012;107(2):263-75.
Summary: The authors recommend changes to the Diagnostic and Statistical Manual of Mental Disorders (DSM) pertaining to nicotine dependence, including: 1) List craving as a nicotine-withdrawal symptom and include it in other drug-withdrawal syndrome descriptions. 2) Measure an individual’s time-to-first-cigarette after awakening and total cigarettes smoked per day in DSM field trials to allow comparisons between these proposed standards and current DSM criteria. 3) Change the name from “nicotine use disorder” to “tobacco use disorder.”
Bolt DM, Piper ME, Theobald WE, Baker TB. Why Two Smoking Cessation Agents Work Better Than One: Role of Craving Suppression. Journal of Consulting and Clinical Psychology. 2012;80(1):54-65.
Summary: The univariate models suggested that the combination treatments produced higher abstinence rates than the monotherapies because of greater suppression of withdrawal, craving, and smoking expectations. However, multiple mediator models showed that the suppression of craving on the quit day produced the strongest mediational effects and could account for the mediational effects of other tested variables. Conclusion: Higher abstinence rates for combination therapy versus monotherapies appear primarily due to greater craving suppression.
Loh W-Y, Piper ME, Schlam TR, Fiore MC, Smith SS, Jorenby DE, Cook JW, Bolt DM, Baker TB. Should All Smokers Use Combination Smoking Cessation Pharmacotherapy? Using Novel Analytic Methods to Detect Differential Treatment Effects Over 8 Weeks of Pharmacotherapy. Nicotine and Tobacco Research. 2012;14(2):131-141.
Summary: Combination medications to quit smoking was generally more effective than monotherapy among smokers, but one group of smokers, those who were low in nicotine dependence and who lived with a smoking spouse, did not show greater benefit from using combination pharmacotherapy. Use of monotherapy with these smokers might be justified considering the expense and side effects of combination pharmacotherapy.
Fiore MC, Goplerud E, Schroeder SA. New Tobacco-Use Measures from the Joint Commission — Will Hospitals Do the Right Thing? New England Journal of Medicine. March 12, 2012.
Summary: New Joint Commission quality measures challenge U.S. hospitals to do more to treat inpatients who use tobacco. While the new tobacco measures are optional, the authors challenge hospitals to adopt them because it’s the right thing to do to treat the leading preventable cause of death in America.
Smith SS. Tobacco and Nicotine Dependence (chapter). In Rippe, J. M. (Ed.) Encyclopedia of Lifestyle Medicine and Health. Ed. James M. Rippe, MD. Thousand Oaks, CA: SAGE, 2012. 2707-18.
Summary: Stevens Smith contributed an invited chapter to the 6-volume Encyclopedia of Lifestyle Medicine & Health, which draws from such areas as cardiovascular health, lifestyle management and prevention, nutrition, environmental stress, obesity and weight management, exercise and sports psychology, pediatric fitness, public policy and health promotion. While not free like Wikipedia, these books contain 850 evidence-based entries by experts in each field, with accompanying bibliographies and suggested readings. Stevens’ chapter focuses on tobacco and nicotine dependence.
Kahn R, Gorgon L, Jones K, McSherry F, Glover ED, Anthenelli RM, Jackson T, Williams J, Murtaugh C, Montoya I, Yu E, Elkashef A. Selegiline Transdermal System (STS) as an Aid for Smoking Cessation. Nicotine & Tobacco Research. Vol. 14, No. 3, March 2012, 377-382.
Summary: This study examined the efficacy and safety of selegiline transdermal system (STS) and brief repeated behavioral intervention (BRBI) for smoking cessation in heavy smokers. We hypothesized that the quit rate of subjects who received STS and BRBI would be significantly greater than that of those who received placebo patch and BRBI. Although STS was well tolerated, the overall results indicated that STS with BRBI was not more effective than placebo plus BRBI for smoking cessation.
Johnson HM, Piper ME, Baker TB, Fiore MC, Stein JH. Effects of Smoking and Cessation on Subclinical Arterial Disease: A Substudy of a Randomized Controlled Trial. PLoS ONE, April 9, 2012.
Summary: To assess change in atherosclerotic burden after smoking cessation, carotid intima-media thickness (CIMT) was measured in 795 smokers at baseline and 3 years after a quit attempt. Individuals who quit had a nominally greater increase in CIMT. Increase in body-mass index and anti-hypertensive medication use independently predicted change in CIMT. The short-term reduction in cardiovascular disease after cessation is unlikely to be mediated by changes in subclinical atherosclerosis burden.
Chen L-S, Baker TB, Grucza R, Wang JC, Johnson EO, Breslau N, Hatsukami D, Smith SS, Saccone N,Saccone S, Rice JP, Goate AM, Bierut LJ. Dissection of the Phenotypic and Genotypic Associations With Nicotine Dependence. Nicotine & Tobacco Research. 2012; 14(4):425-433.
Summary: Cigarettes per day is an important, simple measure that captures in part the genetic associations of the CHRNA5 gene and nicotine dependence, even when other more comprehensive measures of smoking behaviors are examined. The CHRNA5 gene is associated with heavy, compulsive smoking and craving; this should inform the mission to improve the diagnostic validity of DSM-V.
Christiansen BA. What Does It Cost To Change Behavior? Editorial. Annals of Family Medicine 10(3):197-198.
Summary: In an editorial in the same journal, Dr. Joanne Wu proposes paying patients for healthy behaviors such as quitting smoking. Dr. Bruce Christiansen rebuts that, in a Cochrane review of 19 studies, only one reported significantly higher cessation rates for the smokers paid to quit, and that study paid $750 per successful quitter. Christiansen notes that most plans would be able to afford less than $50 per quitter. Further, Christiansen agrees with Dr. Wu and the Cochrane Review on the fact that smokers who quit while being paid usually relapse once the payments cease.
Belsky D, Moffitt TE, Baker TB, Biddle AK, Evans JP, Harrington HL, Houts R, Meier M, Sugden K, Williams B, Poulton R, Caspi A. Polygenic Risk Accelerates the Developmental Progression to Heavy, Persistent Smoking and Nicotine Dependence: Evidence from a 4-Decade Longitudinal Study. JAMA Psychiatry.
Schlam TR, Baker TB. Interventions for Tobacco Smoking. Invited Review for the 2013 Annual Review of Clinical Psychology.
Davis JM, Goldberg SB, Anderson MC, Manley AR, Smith SS, Baker TB. Randomized Trial on Mindfulness Training for Smokers Targeting a Disadvantaged Population. Journal of Substance Use and Misuse.
Dual Use of Cigarettes and Other Tobacco Products in Primary Care and Community Settings. The National Institutes of Health has awarded UW-CTRI a $1.8 million supplement to its NCI-funded center grant. The main grant is designed to develop and test interventions that promote smoking reduction and cessation among primary-care patients. With this supplement, researchers will investigate questions of importance to the FDA in its role of regulating tobacco products:
How dual use of tobacco products (both smoking cigarettes and use of either e-cigarettes or smokeless tobacco) is related to outcomes of public health importance, such as cessation attempts and success. Why dual use affects such outcomes, for instance showing how dual use affects cigarette withdrawal symptoms, smoking reward, and cigarette dependence.
UW-CTRI will use these additional funds in two different ways. In the existing NCI Center Grant Primary Care study, UW-CTRI researchers will add new measures and analyses to the parent study to see how dual use may (or may not) affect the user’s dependence on cigarettes, withdrawal severity, perception of harm, treatment engagement, and smoking outcomes (smoking reduction and cessation). Participants in the parent grant are recruited through primary-care visits. Tanya Schlam will be the lead UW-CTRI scientist on this primary care component.
In the new Community Sample sub-study, researchers will use measures and analyses that will elucidate the mechanisms responsible for the associations observed in the Primary Care sub-study. Doug Jorenby will be the lead scientist on this community sample component, which will recruit 150 daily smokers via advertisements (e.g., convenience stores, TV, social media) throughout the Milwaukee and Madison areas.
- Fifty will smoke cigarettes exclusively.
- Fifty will both smoke cigarettes and use smokeless tobacco.
- Fifty will both smoke cigarettes and use e-cigarettes.
These participants will generate real-time data to determine how dual users and exclusive smokers compare on hedonic ratings of cigarettes, cigarette use, daytime tobacco use, mood, suppression of cigarette withdrawal, contexts of use, and exposure. Moreover, data from dual users will reveal how recency of use of other tobacco products (OTP) affects cigarette use and reward, especially during periods of reduced cigarette intake. Researchers will use the data to compare risk profiles and determine how to improve cessation. September 2012-August 2014. Funded by NIH and FDA. Tim Baker and Michael Fiore, PIs.
Advancing Tobacco Research by Integrating Systems Science and Mixture Models. Megan Piper is a co-investigator on this R01 grant from the National Cancer Institute. The project will advance knowledge of how different smoking-cessation treatments work, for whom, and when. Researchers from Penn State will integrate time-varying effect models and latent class analysis in order to identify subgroups of smokers who experience the process of nicotine withdrawal differently. Research results will guide future smoking-cessation interventions. Only very recently have new approaches become more common thanks to smartphones and other technological advances. Latent class analysis allows researchers to gauge the impact of exposure to patterns of multiple risks, as well as the antecedents and consequences of complex behaviors, so that interventions can be tailored to target the subgroups that will benefit most. Results from the project will inform the construction of interventions that (1) are tailored to the individual and that (2) adapt to participant response over time. Importantly, the overall impact of this project extends far beyond the proposed analysis; the project’s full potential for accelerating the pace of smoking-cessation research will be realized as a result of programmatic dissemination efforts of important new analytic methods to tobacco researchers. August 2012-July 2015. Funded by National Cancer Institute. Stephanie Lanza, PI. Megan Piper, co-I.
Clinical Relevance of Stress Neuroadaptation in Tobacco Dependence. Megan Piper is a co-investigator on this RO1 grant that examines stress neuroadaptation in the laboratory via startle potentiation during uncertain threat among nicotine-deprived smokers versus non-deprived smokers and non-smokers. Smokers will be subsequently assigned to one of three smoking-cessation treatment conditions and will report on episodic stressors, negative feelings, smoking urge, and tobacco consumption in real time from their regular environments via smart phones or other digital devices that prompt them to enter data. Treatment outcome will be assessed at four weeks and end of treatment. The broad goals of this research are to identify the origin of relevant psychophysiological biomarkers of stress neuroadaptation that results from chronic smoking. We evaluate the impact of this stress neuroadaptation on smokers’ feelings, urge, and tobacco consumption during smoking-cessation treatment. We also evaluate if first-line pharmacotherapies can dilute the influence of this stress neuroadaptation on smoking-cessation outcomes. August 1, 2012-June 30, 2017. Funded by NIDA. John Curtin, PI. Tim Baker and Megan Piper, Co-I’s.
Physiological Responses to Tobacco Cues, Abstinence, and Satiation. This research is designed to explore the effects of acute nicotine withdrawal, smoking cue presentation, and smoking itself, on negative emotional response among smokers. During the procedure, the participants will be exposed to a stressor task designed to elicit a mild stress response. The research will also assess how non-smokers react to this stressor task. Smokers (half of whom will have smoked before the study procedures and half of whom will not have smoked for 12 hours and will therefore be in withdrawal) will complete this procedure a total of 3 times: when they first come to the lab, after being exposed to smoking related cues and told they will get to smoke soon, and then after smoking. Non-smokers will complete a similar procedure but they will be told they will get to drink water and then have an opportunity to drink water before doing the task for a third time. Analyses will be performed to address four questions. 1) Do smokers (when they have recently smoked or when they have been deprived for 24 hours) have enhanced anxiety-related startle relative to non-smokers? 2. Does withdrawal from smoking increase anxiety-related startle among daily smokers relative to smokers who were not in withdrawal? 3. Does anticipation of smoking and actually smoking influence anxiety reactivity among daily smokers and is this moderated by withdrawal status (withdrawn vs. satiated)? The results of this experiment could lead to more specific inferences as to the systems and components of emotional response that are affected by tobacco withdrawal, which may likely advance our understanding of both the etiology and treatment of nicotine addiction. Jan. 2012-Jan. 2013, $50,000. Funded by the UW School of Medicine and Public Health, UW SMPH Department of Medicine, and UW Graduate School. Megan Piper, Principal Investigator (PI).
Wisconsin Smokers Health Study 2 (WSHS 2). UW-CTRI has been awarded a new $10-million NHLBI grant to discover the best ways to help Wisconsin residents stop smoking. The new study will essentially extend the Wisconsin Smokers’ Health Study and will be known as WSHS 2. It will include potentially life-saving tests—including artery scans that can signal impending risk of a stroke or heart attack—free of charge. Participants will also get free coaching and medications to help them quit smoking. Mike Fiore, Tim Baker, and Dr. James Stein of UW Preventive Cardiology will serve as lead researchers for this new grant. The original Smoker’s Health Study, launched in 2004, revealed how quitting smoking affects nearly every part of a person’s health, lifestyle, and well-being. Some patients from WSHS will continue participating thanks to this new grant, and their participation will culminate in health data spanning 10 years. The initial phases of the new study, WSHS 2, are already underway, with a terrific response from participants from the original WSHS. The Center will recruit 600-800 smokers as new study participants for WSHS 2. In addition, everyone from the previous study—whether now smoking or not—is welcome to continue their participation. In total, 1,500 individuals will participate in WSHS 2. The study will provide free medical information as well as help to quit smoking from a personal quit coach—something many former smokers say is essential because they felt that giving up cigarettes was like “losing my best friend.” The quit coach is a familiar face who ensures that the patient doesn’t feel like s/he is going through the process alone. All participants will be compensated for time and travel. Each individual participant will receive test results, such as cholesterol levels, artery scans, blood counts, and diabetes tests. These results could signal imminent trouble and save lives. The study will employ medical tests—such as carotid artery ultrasound scans and arterial tonometry—to determine how quitting smoking improves health over time, and how continuing to smoke harms health. These tests concentrate on cardiovascular disease, but will also target conditions such as lung disease and diabetes mellitus. While it is well known that smoking is very dangerous, we know less about how quitting (versus continued smoking) affects health. Every participant will get state-of-the-art active medication: 1) varenicline or 2) nicotine patch + nicotine lozenge or 3) just nicotine patch. The first two medication treatments listed above have offered the highest quit rates of all quit-smoking medications, said Tim Baker. However, these two treatments have never been compared head-to-head. “We’ll not only determine which works better,” Baker said, “but also whether one approach works better with some types of smokers than does the other.” At the end of this research, the researchers hope to enhance knowledge of how to treat smoking optimally, how quitting smoking helps participants to reduce their risk of heart disease, stroke, and cancer, and the mechanisms by which these health benefits occur. Sept. 2011-Nov. 2016, $10 million. Funded by the National Heart, Lung, and Blood Institute. Tim Baker, Michael Fiore, Jim Stein, PIs.
Tobacco Interventions Delivered by Community Agencies to Those Living in Poverty. UW-CTRI has received a $332,000 NIH grant to train staff at four Salvation Army centers (in Green Bay, Appleton, La Crosse and Wausau) to provide a brief intervention with clients who smoke. Bruce Christiansen will lead the project, and this NIH funding results from pilot data collected via an ICTR grant awarded to Dr. Christiansen. More than 37 million Americans live in poverty, and they smoke at twice the rate of other Americans. As a result, they bear a disproportionate burden from tobacco-related diseases. Research also shows many people who are homeless or very poor have either mental-health or substance-abuse issues. Both of these groups tend to smoke at high rates and struggle to make quit attempts using evidence-based methods. This grant tests a brief intervention that challenges smokers’ beliefs that discourage quit attempts. These beliefs include:
- Smoking is both normal and acceptable.
- Willpower is sufficient to quit, rendering outside help unnecessary and irrelevant.
- Evidenced-based treatments are not more effective than other methods.
- Stop-smoking medicines are ineffective, dangerous, addictive and/or too expensive.
- Help in quitting is not available, hard to access and/or too expensive.
The goal of the intervention is to correct these misconceptions so they’ll consider quitting smoking. As a control, another 140 clients will be randomized into a 15-minute intervention with a Salvation Army counselor reading through a booklet on smoking and health, but without any behavioral or motivational interviewing. Another control group, consisting of 140 clients, will be given a booklet to peruse by themselves. All three groups will be compared with 100 participants who are already ready to quit smoking. There’s a follow-up phone call after three months. Sept. 2011-Sept. 2013, $332,000. Funded by NCI. Bruce Christiansen, PI.
A Phase 4 Safety and Efficacy Study of Varenicline for Smoking Cessation in Subjects With and Without a History of Psychiatric Disorders. Doug Jorenby is leading this study, funded by Pfizer and initiated by the FDA in response to boxed warnings for patients with and without psychiatric comorbidities. In Phase 3, many subjects with psychiatric disorders were not included per protocol by the use of the following exclusion criteria; “Subjects currently or within the past 12 months requiring treatment for depression. Subjects with current or prior history of panic disorder, psychosis, or bipolar disorder.” In this study, recruitment will be balanced equally with respect to subjects with and without a diagnosis of major psychiatric disorder to allow for the assessment of neuropsychiatric events in each of the cohorts and each of the treatment groups. Subjects will be randomized to receive varenicline, placebo, bupropion hydrochloride or transdermal nicotine patch, the latter two being included as active controls. This very large study will provide a reference standard for the incidence of adverse mental health events during smoking cessation using all major evidence-based treatments. Nov. 2011-present. Funded by Pfizer. Doug Jorenby, PI.
State Medicaid Grant: Striving to Quit. Wisconsin has received a five-year, $9.2 million grant from the federal Centers for Medicare and Medicaid Services to help Medicaid recipients to quit smoking through mechanisms such as the Wisconsin Tobacco Quit Line (QL) and the First Breath Program. Approximately $6.2 million will be managed by UW-CTRI. The purpose of the grant is to help determine whether monetary incentives increase engagement of smokers into treatment, and whether that leads to more people quitting smoking. The Wisconsin Department of Health Services (DHS) will lead the grant, collaborating with the state Medicaid program, First Breath (FB), and UW-CTRI. The grant, called Striving to Quit, has two full-time UW-CTRI regional outreach specialists written in for three years. It will offer evidence‐based cessation counseling plus incentives to two groups:
- Adult BadgerCare Plus members who smoke and reside in South Central and Northeastern Wisconsin will be referred to QL. Participants will get five coaching calls and eight weeks of combination nicotine-replacement medication. Some will get incentives, some won’t.
- Pregnant BadgerCare Plus members in five counties in Southeastern and South Central Wisconsin will work face-to-face with FB health educators. These participants will receive nine visits and seven monthly phone calls. One group will take four CO tests and receive incentives for participation. Another group will get the same visits and calls but not the incentives.
There are 105,417 adult BadgerCare Plus members in these identified areas. Of these, an estimated 40,000 smoke (38%). Striving to Quit aims to treat 4,000 with incentives and another 4,000 without incentives. If a quarter quit smoking, savings from reductions in health care costs are estimated at $3.2 million over the course of the initiative. The FB component of the grant includes a special focus on engaging pregnant African American women who smoke in counties with extremely high rates of birth disparities. Striving to Quit will link them to evidence‐based treatment services by face‐to‐face contacts through First Breath, supplemented by phone support. The rationale for a different approach for pregnant women is based on findings from the QL data indicating that only one to two percent of all pregnant women who smoke call the QL for assistance. Induction to the QL component of the study is similar to that of UW-PASS. When the BadgerCare Plus member visits a participating clinic, a clinic staff person—generally the medical assistant (MA)—identifies the patient as a smoker via an expanded vital signs protocol that includes an assessment of smoking status. At this baseline visit, the MA also obtains an expired air CO measure from the smoker. Results of the test are tracked either via an electronic health record (EHR) or the member’s HMO tobacco registry. The CO level is also shared with the QL if the member agrees to the referral. The MA briefly explains the availability of free treatment services and monetary incentives and informs the patient that s/he will get a call from the QL within 48 hours. Provider education and awareness materials will mirror that of the UW‐CTRI campaign, “You Can Afford to Quit: Medicaid Covers It.” In addition, DHS, UW‐CTRI and FB will work with the HMOs to host a series of educational events for providers. “This grant offers a tremendous opportunity to improve the health of thousands of Wisconsin residents with low incomes,” said Mike Fiore. “We’re excited to see whether financial incentives increase rates of smoking cessation among BadgerCare Plus members. It’s terrific to be a part of this grant and to partner with our esteemed collaborators.” Sept. 2011-Sept. 2016, $9.2 million. Funded by federal Centers for Medicare and Medicaid Services. Tim Baker, PI.
UW Partnership to Assist and Serve Smokers (UW-PASS). A $9 million P-50 grant from the National Cancer Institute is providing five years of funding for UW-CTRI to study various quit-smoking treatments in primary-care clinics throughout Wisconsin. In this study, led by Michael Fiore and Tim Baker, UW-CTRI will deliver seamless, cutting-edge treatments for all smokers, including those who are ready to quit and those who aren’t. Beginning in the summer of 2010, UW-CTRI will offer participation to patients who smoke and visit select primary-care clinics within three healthcare systems—Dean Health System, MercyCare Health System and Aurora Health Care. Medical assistants at partnering clinics will identify smokers and ask if they’re interested in being contacted about a study. They will invite all smokers whether they are willing to quit or not. If the patient is interested, an e-mail is generated from the electronic medical record to UW-PASS staff, employed by UW-CTRI, who conduct screening, orientation, patient visits and follow up. The electronic medical records will be supported by Epic Systems Corp. and Cerner. UW-PASS includes three projects:
- Project 1 focuses on increasing the smoker’s motivation to quit. This project will offer treatment strategies for smokers who aren’t ready to quit now but are willing to participate in treatment to help them get ready to quit. The hope is to increase their motivation to quit smoking as well as to make actual quit attempts. Treatments include behavioral coaching, motivational interviewing, nicotine patches, and nicotine gum.
- Project 2 of UW-PASS will examine whether use of nicotine-replacement medication and behavioral coaching—before actually quitting smoking—helps the patient remain smoke-free. Typically, those who use nicotine-replacement medications (such as the nicotine patch or lozenge) quit smoking first, then use medications to stave off cravings and remain smoke free. Project 2 will also test coaching types and lengths, including in-person coaching vs. telephone coaching.
- Project 3 is designed to study ways to increase the number of patients who take quit-smoking medication at the proper dosage for the prescribed duration. Most smokers don’t use enough medication or use it the right way. The goal is to see what happens if a patient takes medication as prescribed vs. skipping doses or ceasing treatment prematurely. Adherence treatments include automated-adherence phone prompts, electronic monitoring/feedback and a cognitive-adherence intervention. Project 3 will also look at the outcomes of long-term coaching and medication.
Sept. 2009-Aug. 2014. NIH (NCI) P-50 grant. Tim Baker and Michael Fiore, PI.
Veterans and Smoking Studies. Jessica Cook is leading a study at the William S. Middleton Memorial VA Hospital in Madison. The study tests the hypothesis that smokers with posttraumatic stress disorder (PTSD) and depression smoke cigarettes to improve aversive mood states and other mental health symptoms. The effect Cook is most interested in is whether smoking regulates anhedonia, a common feature of both PTSD and depression that is characterized by an inability to respond to pleasurable events. The first part of the study examines how nicotine influences mood responses to positive and negative stimuli. The second part of the study will be done at a critical point, 24 and 48 hours after being deprived of nicotine, which can be the peak of withdrawal. It’s then that the team will explore whether veterans with PTSD and depression have a more difficult time experiencing pleasure in response to rewarding events and whether they experience more withdrawal-related negative affect. Oct. 2007-Aug. 2013. NIH funded (NIDA). Jessica Cook, PI.
Mindfulness Study. James Davis has developed a seven-week smoking-cessation intervention that teaches participants to use mindfulness skills to manage relapse challenges such as triggers, urges, withdrawal symptoms and strong emotions. He is currently running three studies to assess the effectiveness of this intervention. The first study is a randomized trial (n =196) comparing mindfulness training to the Wisconsin Tobacco Quit Line. It has just been completed and shows that participants with the mindfulness training have significantly higher abstinence rates than controls in several outcome measures. The second study is a randomized trial (n = 180) that compares mindfulness training to a time/intensity matched seven-week intervention based on the American Lung Association Freedom from Smoking Program. This study is midway through recruitment and interim results look promising. The third study (n = 50) is designed to assess the feasibility of providing mindfulness training over the Internet. If a web-based version of mindfulness training appears to be effective, it could provide for wider dissemination of the intervention. Feb. 2008-Aug. 2013. NIH funded (NIDA). James Davis, PI.
Helping Patients with Persistent Mental Illness Prepare to Quit Smoking. UW-CTRI is part of a $200,000 community collaboration to help motivate patients with persistent mental illness to quit smoking, partnering with the National Alliance on Mental Illness (NAMI). UW-CTRI Researcher Bruce Christiansen is leading the two-year project, which will reach out to 172 patients via 13 community-support programs (CSPs). Bruce joined Jennifer Lowenberg (NAMI) and Jana Frey, PhD (Program of Assertive Community Treatment–PACT) to present a webinaron the topic. The intervention will be delivered by certified peer counselors who are also former smokers recovering from mental illness. These coaches will be recruited by Lowenberg for this project. Each participant will have the same coach throughout the program—a key element to establishing a rapport and offering a social bond to offset the loss of cigarettes, which many smokers consider their “best friend.” Bruce admitted this project is the tip of the iceberg in terms of the funding, flexibility, and breadth needed to help this population. Still, it’s a start. May 2011-May 2013. Funded by the UW Institute for Clinical and Translational Research (ICTR). Bruce Christiansen, PI.
Qualitative Analysis of American Indian Tobacco Use and Research Participation. Dr. Leah Arndt (UW-Milwaukee) is Principal Investigator and Dr. Stevens Smith of UW-CTRI is Co-Investigator on a 3-year pilot study (7/1/2010-6/30/2013; $187,562). This pilot study is funded through a parent grant, “Spirit of Eagles Community Network Program” (U54 CA153605; PI: Judith Kaur, MD, Mayo College of Medicine) funded by the National Cancer Institute. Spirit of Eagles (SOE) is a multidisciplinary national program that coordinates and assesses a national cancer research program for American Indian/Alaska Native (AI/AN) communities to address cancer disparities in this population. Cancer health disparities are addressed in SOE by implementing and assessing innovative and culturally-appropriate research through community-driven partnerships. In the pilot study, Dr. Arndt and colleagues are conducting additional qualitative analyses of interview data collected in the Menominee Smoking Cessation Clinical Trial (10/1/2008-9/30/2011; $453,449; funded by the Wisconsin Partnership Program; PI: Stevens Smith, PhD) that tested a culturally-tailored cessation intervention (versus standard treatment) in 108 AI/AN smokers at the Menominee Tribal Clinic. July 2010-June 2013. Funded by NCI and the Center for Urban Population Health in Milwaukee, WI. Dr. Leah Arndt, PI and Dr. Stevens Smith, Co-I.
Recently Completed Studies
(In data analysis and preparation of papers)
Using the Electronic Health Record (EHR) Platform to Identify Smokers Visiting Primary Care Clinics, to Deliver Evidence-Based Tobacco Dependence Treatments, and to Link Those Smokers Electronically With a State-Based Cessation Quitline. For this $200,000 grant, Rob Adsit, Michael Fiore and colleagues at UW-CTRI collaborated with Dean Clinic to design and implement a second generation of the tobacco cessation EHR module. Specifically, this involved UW-CTRI working with the Dean Clinic clinical and IT team to modify this health system’s clinical module, algorithm and workflow to improve clinician performance, increase treatment interventions and improve patient outcomes. They built and integrated a mechanism to allow clinicians to refer patients to the Wisconsin Tobacco Quit Line directly from the EHR module. This component involved working with the EHR vendor, Epic Systems Corp., and the Wisconsin Tobacco Quit Line vendor, Free and Clear, as well as Dean Clinic. NCI funded. Michael Fiore, PI.
Evaluation of two National Cancer Institute Web sites. Tim Baker leads this evaluation ofwww.SmokeFree.gov and www.women.smokefree.gov. The primary goal of this research is to obtain experimental data on the effectiveness of the National Cancer Institute’s Smokefree.gov and Cancer Information Service quit line. Secondary goals are to:
- Determine how much the participants use the interventions.
- Identify the factors that appear to enhance or interfere with the success of the intervention (such as stressors, environmental factors and the like).
- Compare benefits for important smoker populations.
- Determine whether any of the interventions produce subtractive or synergistic effects
- Obtain basic estimates on the economics involved, such as cost per quitter.
The project will also include a sub-study directed toward 100 pregnant women (or women who are interested in participating but are unwilling to agree to utilize approved contraceptive methods for the duration of the study). This sub-study will utilize all of the treatment conditions except the medication condition, since medication is not recommended for women who are pregnant in the U.S. Department of Health and Human Services treatment guideline for tobacco dependence. Funded by Matthews Media Group. Tim Baker, PI.
Study on Public Health ROI Resulting from State and Federal Policies. In this $200,000 Robert Wood Johnson Foundation study, Michael Fiore collaborated with Frank Chaloupka of the University of Illinois-Chicago to examine the effects of policy changes, such as increases in tobacco taxes and smoke-free indoor air laws, and funding changes to state tobacco-control programs. Megan Sheffer served as lead scientist, Fiore as the principal investigator. They measured changes in terms of the impact on cigarettes smoked, quit rates and prevalence—all framed as return on investment for public health. Robert Wood Johnson Foundation funded. Michael Fiore, PI.
Quit Line Study. Stevens Smith and Kate Kobinsky led this study that is testing three enhancements to the Wisconsin Tobacco Quit Line in a randomized clinical trial funded by a two-year, $1 million ARRA stimulus grant from the National Cancer Institute. They tested three enhancements:
- Combination nicotine replacement therapy (versus the nicotine patch alone).
- Extended duration of medication (six weeks versus two).
- A counseling strategy to ensure callers are taking the appropriate doses of their cessation medication for the recommended duration.
UW-CTRI appreciates support from the Wisconsin Department of Health Services (DHS), which sponsored TV ads promoting the Quit Line, which has had a positive effect on study recruitment. DHS also generously provides funding for baseline Quit Line services. NIH funded (NCI). Stevens Smith, PI