UW-CTRI 2011 Research Report


OVERVIEW: This report constitutes the second in a series of 12-month updates on UW-CTRI research. These reports, released on or around January 1 each year by the UW-CTRI Communications Office, summarize published and in-press manuscripts, as well as new and ongoing grants, contracts and other research projects.

 

SUMMARY: In 2011, the UW-CTRI research team produced:

 

26 published papers

5 papers in press

5 new studies

7 ongoing studies

3 completed studies


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, and the Robert Wood Johnson Foundation.

 

Published Papers

Note: Names in bold are either current UW-CTRI employees, or were at the time of publication.

 

1) Gustafson DH, Shaw B, Isham A, Baker T, Boyle M, Levy M. Explicating an Evidence-Based, Theoretically Informed, Mobile Technology-Based System to Improve Outcomes for People In Recovery for Alcohol Dependence. Substance Use & Misuse. 2011;46(1):96-111.


Summary: Post-treatment relapse to uncontrolled alcohol use is common. Currently available communication technology can use existing models for relapse prevention to cost-effectively improve long-term relapse prevention. This paper describes: (1) research-based elements of alcohol consumption-related relapse prevention, (2) how technology could aid recovery, (3) a technology-based prototype, and (4) how we are testing a system based on the ideas in this article.

2) Japuntich SJ, Piper ME, Leventhal AM, Bolt DM, Baker TB. The Effect of Five Smoking Cessation Pharmacotherapies on Smoking Cessation Milestones. Journal of Consulting and Clinical Psychology. 2011;79(1):34-42.


Summary: Results show that all five tested medications from this transdisciplinary study improved initial abstinence and most (with the exception of the nicotine lozenge) decreased lapse risk; however, only the nicotine patch and bupropion + lozenge conditions affected the lapse-relapse transition. These findings demonstrate that medications are effective at aiding initial abstinence and decreasing lapse risk but that they generally do not decrease relapse risk following a lapse.

 

3) Piper ME, Cook JW, Schlam TR, Jorenby DE, Baker TB. Anxiety Diagnoses in Smokers Seeking Cessation Treatment: Relations with Tobacco Dependence, Withdrawal, Outcome, and Response to Treatment. Addiction. 2011 Feb;106(2):418-27.

 

Summary: A structured clinical interview identified participants who ever met criteria for a panic attack (n = 455), social anxiety (n = 199) or generalized anxiety disorder (n = 99), and those who qualified for no anxiety diagnosis (n = 891). Anxiety diagnoses were common among treatment-seeking smokers and were related to increased motivation to smoke, elevated withdrawal, lack of response to pharmacotherapy and impaired ability to quit smoking. These findings could guide treatment assignment algorithms and treatment development for smokers with anxiety diagnoses.

 

4) Baker TB, Hawkins RP, Pingree S, Roberts L, McDowell H, Shaw B, Serlin RC, Dillenburg L, Swoboda C, Han J-Y, Stewart J, Carmack-Taylor C, Salner A, Schlam TR, McTavish F, and Gustafson DH. Optimizing eHealth Breast Cancer Interventions: Which Types of eHealth Services are Effective? Translational Behavioral Medicine: Practice, Policy, and Research. Volume 1, Number 1, 134-145.

 

Summary: A randomized trial explored which types of services of an Interactive Cancer Communication System (ICCS) benefited patients. Women with breast cancer (N=450) were randomized to different types of ICCS services or to a control condition that provided Internet access. ICCS services providing information and support, but not coaching such as cognitive-behavior therapy, produced significant benefits in health-information competence and emotional processing. More complex and interactive services designed to train the user had negligible effects.


5) Hawkins RP, Pingree S, Baker TB, Roberts LJ, Shaw B, McDowell H, Serlin R, Dillenburg L, Swoboda CM, Han J-Y, Stewart JA, Carmack CL, Salner A, Schlam TR, McTavish F, Gustafson D. Integrating eHealth with Human Services for Breast Cancer Patients. Translational Behavioral Medicine. Volume 1, Number 1, 146-154.

 

Summary: Both a human mentor and computer software improved health-information competence and emotional processing over a control treatment. The combined condition—mentor + software—exceeded either alone. Integrating human and computer-based resources for breast cancer patients benefits them more than either alone.

 

6) Schlam TR, Japuntich SJ, Piper ME, Gloria R, Baker TB, Curtin JJ. Cognitive Conflict Following Appetitive Versus Negative Cues and Smoking Cessation Failure. Psychopharmacology. 2011;214:603-616.

 

Summary: The object of this study was to determine whether smokers' pre-quit reaction times on a computerized modified Simon task (arrows that illuminate to the left or right) predict smoking abstinence. Greater impairment in executive control after viewing positive and smoking slides relative to negative slides predicted an inability to establish initial cessation and to maintain abstinence up to 8 weeks post-quit. These effects may be because smokers who avoid/escape from processing negative affect are more likely to fail in a cessation attempt.

 

7) Japuntich SJ, Leventhal AM, Piper ME, Bolt DM, Roberts LJ, Fiore MC, Baker TB. Relations Between Smoker Characteristics and Smoking Cessation Milestones. American Journal of Preventive Medicine.

 

Summary: High nicotine dependence strongly predicted all milestones: Not achieving initial abstinence, as well as a higher risk of both lapse and transitioning from lapse to complete relapse. Numerous contextual and demographic variables were associated with higher initial cessation rates and/or decreased lapse risk at six months post-quit (e.g., ethnicity, gender, marital status, education, smoking in the workplace, number of smokers in the social network, and number of supportive others). However, aside from nicotine dependence, only gender significantly predicted the risk of transition from lapse to relapse.

 

8) Hatsukami DK, Jorenby DE, Gonzales D, Rigotti NA, Glover ED, Oncken CA, Tashkin DP, Reus VI, Akhavain RC, Fahim REF, Kessler PD, Niknian M, Kalnik MK, Rennard SI. Immunogenicity and Smoking Cessation Outcomes for a Novel Nicotine Immunotherapeutic. Journal of Clinical Pharmacy and Therapeutics. 89 3, 392–399.

 

Summary: Results from this study support the concept that high levels of an anti-nicotine vaccine are associated with higher rates of abstinence. These findings suggest that vaccines which confer high levels may be more effective. Other future strategies may include examining additional ways to increase higher antibody concentrations levels across all individuals. Nonetheless, this study demonstrates that vaccine 3′AmNic-rEPA has significant potential as an aid to smoking cessation and perhaps also to relapse prevention.

 

9) Gepner AD, Piper ME, Johnson HM, Fiore MC, Baker TB, Stein JH. Effects of Smoking and Smoking Cessation on Lipids and Lipoproteins: Outcomes from a Randomized Clinical Trial. American Heart Journal. 161, 145-151.

 

Summary: Despite weight gain, smoking cessation improved “good” cholesterol—HDL-C, total HDL, and large HDL particles—especially in women. Smoking cessation did not affect “bad” cholesterol—LDL or LDL size. Increases in HDL may mediate part of the reduced cardiovascular-disease risk observed after smoking cessation. Clinically, there may have been other behavior changes related to specific patients quitting (e.g., dietary changes) that may have influenced the LDLs, but this is generally not the case for smokers who successfully quit.

10) Collins LM, Baker TB, Mermelstein RJ, Piper ME, Jorenby DE, Smith SS, Christiansen BA, Schlam TR, Cook JW, Fiore MC. The Multiphase Optimization Strategy for Engineering Effective Tobacco Use Interventions. Annals of Behavioral Medicine. 2011 Apr;41(2):208-26.

 

Summary: The multiphase optimization strategy (MOST) is a new methodological approach for building, optimizing, and evaluating multicomponent interventions. Conceptually rooted in engineering, MOST emphasizes efficiency and careful management of resources to move intervention science forward steadily and incrementally. MOST can be used to guide the evaluation of research evidence, develop an optimal intervention, and enhance the translation of research findings, particularly type II translation.

11) McCarthy DE, Baker TB, Minami HM, Yeh V. Chapter title is: Applications of Contemporary Learning Theory in the Treatment of Drug Abuse. Edited by Reilly S and Schachtman TR. Book title is: Associative Learning and Conditioning: Human and Animal Applications. New York: Oxford University Press.

 

Summary: This chapter discusses how recent developments in learning theory and science can be used to understand addictive behavior, and how they can suggest new avenues to treatment. While there are previous chapters on basic learning-theory paradigms and their relevance to addiction, this chapter focuses on more recent developments in such areas as context effects, extinction, and habit learning.

12) Piper ME, Schlam TR, Cook JW, Sheffer MA, Smith SS, Loh W-Y, Bolt DM, Kim SY, Kaye JT, Hefner KR, Baker TB. Tobacco Withdrawal Components and Their Relations with Cessation Success. Psychopharmacology. 2011 Mar 18 [Epub ahead of print].

 

Summary: Real-time measurement of craving and negative affect following a cessation attempt revealed that craving symptoms differed from negative affect symptoms, with higher means, greater variability, and a greater incidence of extreme peaks. Regression analyses revealed that abstinence was associated with lower mean levels of both craving and negative affect, as well as fewer incidences of extreme craving peaks. In a multivariate model, the increase in mean craving and negative affect scores each uniquely predicted relapse.

 

13) Baker TB, Mermelstein R, Collins LM, Piper ME, Jorenby DE, Smith SS, Christiansen BA, Schlam TR, Cook JW, Fiore MC. New Methods for Tobacco Dependence Treatment Research. Annals of Behavioral Medicine. 2011 Apr;41(2):192-207.

 

Summary: This paper reviews pervasive methodological issues that may contribute to the lack of timely progress in tobacco treatment science. This includes the lack of a dynamic model or framework of the cessation process, inefficient study designs, and the use of distal outcome measures that poorly index treatment effects. The authors then present a phase-based cessation framework that partitions the cessation process into four discrete phases based on current theories of cessation and empirical data. These phases include: (1) Motivation, (2) Precessation, (3) Cessation, and (4) Maintenance.

 

14) Hughes JR, Baker TB, Breslau N, Covey L, Shiffman S. Applicability of DSM Criteria to Nicotine Dependence (commentary). Addiction. 2011;106:894-5.

 

Summary: The authors suggest DSM-V contain the following changes: • Include measures of time-to-first-cigarette and cigs/day in DSM field trials to allow comparisons with DSM criteria. Consider parallel measures of urgency and heaviness of use for other drug dependencies; • Include craving as a nicotine withdrawal symptom and include it in other drug-withdrawal-syndrome descriptions because withdrawal-associated craving is highly predictive of clinical outcomes; • Change the name from ‘nicotine use disorder’ to ‘tobacco use disorder.’

 

15) Piasecki TM, Piper ME, Baker TB. WISDM Primary and Secondary Dependence Motives: Association with Self-Monitored Motives for Smoking in Two College Samples. Drug and Alcohol Dependence. 2011 April; 114(2-3):207-16.

 

Summary: Among two samples of college smokers with electronic diaries, primary dependence motives (PDM) scores were associated with diary endorsement of habitual or automatic motives for smoking. Secondary dependence motives (SDM) didn’t clearly predict self-monitored motives when tested alone. However, when these composites were co-entered, PDM predicted daily vs. nondaily smoking, being higher in nicotine dependence, and smoking cigarettes out of habit or automaticity. This suggests the PDM composite may reflect core motivational features of nicotine dependence in these young smokers.

 

16) Piper ME, Loh W-Y, Smith SS, Japuntich SJ, Baker TB. Using Decision-Tree Analysis to Identify Risk Factors for Relapse to Smoking. Substance Use and Misuse. 2011;46(4):492-510. Epub 2010 Apr 16.

 

Summary: This research used classification-tree analysis and logistic-regression models to identify risk factors related to short- and long-term abstinence. Researchers analyzed baseline and cessation data from two smoking-cessation trials conducted from 2001 to 2002. Both analyses suggest that relapse risk is produced by interactions of risk factors; further, early- and late-cessation outcomes reflect different vulnerability factors. The results illustrate the dynamic nature of relapse risk and suggest the importance of efficient modeling of interactions in relapse prediction.

 

17) Minami H, McCarthy DE, Jorenby DE, Baker TB. An Ecological Momentary Assessment Analysis of Relations Among Coping, Affect, and Smoking Lapse. Addiction. 2011 Mar;106(3):641-50.

 

Summary: Multi-level models indicated that a single coping episode did not predict a change in smoking risk over the next 4 or 48 hours, but coping in men was associated with concurrent reports of increased smoking. Coping predicted improved positive and negative affect reported within four hours of coping, but these affective gains did not predict reduced likelihood of later smoking. Coping responses early in a quit attempt may help smokers trying to quit to feel better, but may not help them stay smoke-free.

 

18) Sheffer MA and Squier C. Chapter title is: Up in Smoke: A Recent History of Iowa Smoke-free Legislation & Public Health Outcomes. Edited by Mark JA, Champagne Bolduc J, and Quinn N. Book title is: Needs and Capacity Assessment Strategies for Health Education and Health Promotion. Sudbury: Jones and Bartlett.

19) Keller PA, Christiansen BA, Kim S-Y, Piper ME, Adsit RT, Redmond LA, Fiore MC. Increasing Consumer Demand Among Medicaid Enrollees for Tobacco Dependence Treatment: The Wisconsin Medicaid Covers It Campaign. American Journal of Health Promotion, 2011 Jul-Aug;25(6):392-5.


Summary: This natural experiment demonstrated statistically significant improvements in both pharmacotherapy claims and Quit Line registrations among Medicaid enrollees. These findings may help inform other states' efforts to improve cessation treatment utilization.

20) Julius BR, Ward BA, Stein JH, McBride PE, Fiore MC, Baker TB, Nieto J, Colbert LH. Ambulatory Activity Associations with Cardiovascular and Metabolic Risk Factors In Smokers. Journal of Physical Activity and Health. 2011 Sep; 8(7): 994-1003.

 

Summary: Greater ambulatory activity among smokers trying to quit is associated with lower levels of metabolic and cardiovascular risk factors in female smokers which may, in part, be mediated by a reduction in BMI.

21) Fiore MC, Baker TB. Treating Smokers in the Health Care Setting. New England Journal of Medicine. Sept. 29, 2011; Vol.365: No.13; p.1222-1231.

 

Summary: This guideline article updates the best practices on treating tobacco dependence, including how to help smokers who aren’t yet ready to make a quit attempt as well as those who are. One important advance is the advice to start counseling and medication with the patient before the quit date. Graphics include practical tips on motivational intervention as well as a flow chart for clinical implementation of the 5 A’s.

 

22) 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.

 

Summary: The authors recommend changes to the Diagnostic and Statistical Manual of Mental Disorders (DSM) pertaining to nicotine dependence, including listing: 1) Craving as a nicotine-withdrawal symptom.  2) Withdrawal-associated craving as highly predictive of clinical outcomes. 3) Measurement of an individual’s time-to-first-cigarette after awakening and total cigarettes smoked per day. 4) The disorder as “tobacco use disorder” rather than “nicotine use disorder.”

 

23) Bolt DM, Piper ME, Theobald WE, Baker TB. Why Two Smoking Cessation Agents Work Better Than One: Role of Craving Suppression. Journal of Consulting Clinical Psychology. [Epub Ahead of print].

               

Summary: This research examined why smokers receiving combination medication for smoking cessation are more likely to quit smoking than are those who receive either single agent (monotherapy) or placebo. Data were collected from 1,504 current smokers participating in a cessation clinical trial who were randomized to 1 of 6 pharmacotherapy conditions. The higher abstinence rates for combination therapy versus monotherapies appear primarily due to greater craving suppression.


24) Boyle R, Solberg L, Fiore MC. Use of Electronic Health Records to Support Smoking Cessation. Cochrane Database System Revue. Dec. 7, 2011.

 

Summary: A team of researchers reviewed 11 studies on the effect of electronic health records (EHR) on the actions of clinicians to treat tobacco dependence and found only modest improvements in recommended clinician actions. While documentation of tobacco use and referral to cessation counseling appeared to increase, patient smoking cessation was not demonstrated. In the short term, there were increases in documentation of tobacco status and referral to cessation counseling after EHR implementation. There is a need for additional research.

 

25) 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 referrals more than fıvefold over a fax referral program implemented without such enhanced academic detailing.

 

26) Hudmon KS, Addleton RL, Vitale FM, Christiansen BA, Mejicano GC. Advancing Public Health Through Continuing Education of Health Care Professionals. Journal of Continuing Education in Health Professions. 2011;31(S1):S60-S66.

 

Summary: This article describes how the CS2day (Cease Smoking Today) initiative positioned continuing education (CE) in the intersection between medicine and public health. The authors suggest that most CE activities address the medical challenges that clinicians confront, often to the neglect of the public health issues. The article concludes by stating that the successful results of the CS2day initiative illustrate what can happen when continuing education efforts develop from a public health problem rather than just a practice gap identified in a clinical practice setting.

 

In Press

 

1) 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.

2) 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 & Tobacco Research.

 

3) Smith SS. Tobacco and Nicotine Dependence. In Rippe, J. M. (Ed.) Encyclopedia of Lifestyle Medicine and Health. Thousand Oaks, CA: Sage Publications, Inc.

 

4) Mejicano GC, Sichanek Hudmon K, Addleton RL, Vitale FM, Christiansen BA. Advancing Public Health Through Continuing Education of Healthcare Professionals. Journal of Continuing Education in The Health Professions.

 

5) Piper ME, Kenford S, Fiore MC, Baker TB. Smoking Cessation and Quality of Life: Changes in Life Satisfaction Over Three Years Following a Quit Attempt. Annals of Behavioral Medicine.

 

New Studies


1) 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. Beginning in early 2012, UW-CTRI researchers will recruit 600 new smokers from the Milwaukee and Madison areas to participate. In addition, everyone from the previous WSHS—whether now smoking or not—is welcome to continue their participation; researchers expect about 900 of these individuals to continue in the study, resulting in a total enrollment of 1500 for WSHS-2. The study will provide free medical information on how 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 gum/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-April 2016, $10 million. Funded by the National Heart, Lung, and Blood Institute.

2) 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 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. Research 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 more than most to quit. So the grant offers modest financial incentives to the smokers and also removes barriers to quitting. For example, while the intervention is just one short session for practical reasons, the Salvation Army has agreed to make telephones available for smokers to call the Wisconsin Tobacco Quit Line. Bruce plans to recruit 140 smokers total who aren’t ready to quit from Salvation Army locations in Green Bay, Appleton, La Crosse and Wausau. There’s a follow-up phone call after three months, also with a modest incentive to those who participate. 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. A number of beliefs particularly prominent among those living in poverty create barriers to their use of evidence-based treatment. These beliefs include:

 

1) Smoking is both normal and acceptable.

2) Willpower is sufficient to quit, rendering outside help unnecessary and irrelevant.

3) Evidenced-based treatments are not more effective than other methods.

4) Stop-smoking medicines are ineffective, dangerous, addictive and/or too expensive.

5) 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. Sept. 2011-Sept. 2013, $332,000. Funded by NCI.

 

3) 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-Nov. 2013, $480,000. Funded by Pfizer.

 

4) 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:


a) 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.


b) 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.

 

5) 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 webinar on 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 repoire 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).

 

Ongoing Studies

 

1) Evaluation of two National Cancer Institute Web sites. Tim Baker leads this evaluation of www.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. The contract is for $650,000 and runs from Nov. 2010 to April 2012. Funded by Matthews Media Group.

 

2) 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.

3) Study on Public Health ROI Resulting from State and Federal Policies. In this $200,000 Robert Wood Johnson Foundation study, Michael Fiore is collaborating 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 will serve as lead scientist, Fiore as the principal investigator. They’ll measure changes in terms of the impact on cigarettes smoked, quit rates and prevalence—all framed as return on investment for public health. May 2010-April 2012. Robert Wood Johnson Foundation funded.

4) 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. 2012. NIH funded (NIDA).

5) 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).

6) Quit Line Study. Stevens Smith is leading 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. The three enhancements being tested simultaneously include:

·         Combination nicotine replacement therapy (versus the nicotine patch alone).

·         Extended duration of medication (six weeks versus two).

·         An innovative 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. Sept. 2009-Aug. 2011. NIH funded (NCI).

 

7) 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. Sept. 2010-Aug. 2012. NCI funded.

 

Completed Studies (In data analysis and preparation of papers)


1) Menominee Smoking Cessation Clinical Trial. Stevens Smith was the principal investigator for this collaboration with the Menominee Indian Tribe of Wisconsin and investigators at UW-Milwaukee and the UW Carbone Cancer Center. The goal of this study was to test a culturally tailored treatment versus standard treatment in 150 American Indian smokers at the Menominee Tribal Clinic. The study also included qualitative analyses of participant interviews intended to help to inform future treatment improvements. Oct. 2008-Sept 2011. Funded by the Medical Education and Research Committee (MERC) of the Wisconsin Partnership Program at the UW School of Medicine and Public Health.

 

2) CDC Fax to Quit. Michael Fiore and Megan Sheffer led this study examining the effective ways of supporting clinics to enroll patients for services from the Wisconsin Tobacco Quit Line via fax. Some of the clinics received training and technical assistance from UW-CTRI staff; other clinics in the study got only program materials. Initial findings show that ongoing training and technical assistance boosts patient use of the Fax to Quit Program five-fold. Sept. 2007-June 2011. CDC funded.

 

3) Smoking Cessation-related Information, Motivation, and Behavioral Skills Specific to HIV-infected Smokers. James Sosman led this study, which endeavors to describe the level of smoking and smoking-related information, motivation, and behavioral skills among a sample of Wisconsin HIV-positive smokers. Identifying this information with regard to HIV-positive smokers is informing the development of a smoking intervention tailored to HIV-positive smokers. The goal of this study was to advance the understanding of unique issues regarding tobacco use and HIV/AIDS, as a first step to intervening on a major public health problem among a vulnerable population where few interventions currently focus—on groups who may have the most difficulty quitting smoking. Sept. 2009-April 2011. Funded by the UW Institute for Clinical and Translational Research (ICTR), which in turn is supported by grants from NIH.