1986 — 1988 |
Baker, Timothy B |
R01Activity Code Description: To support a discrete, specified, circumscribed project to be performed by the named investigator(s) in an area representing his or her specific interest and competencies. |
Psychosocial Stressors, Smoking Cessation and Cv Risk @ University of Wisconsin Madison
The proposed research is intended to provide: (a) important new information on methods to promote smoking cessation, and (b) information on the conditions of elicitation and characteristics of smoking urges. Resulting research is intended to increase the effectiveness of smoking cessation strategies and our understanding of tobacco dependence and relapse. In Study 1 we will compare rapid smoking and two forms of nicotine gum treatment on their effectiveness in producing cessation. These treatments are the best supported types of smoking interventions, yet they have never been directly compared. Moreover, it has never been shown that rapid smoking produces effects that could not be accounted for by nicotine replacement per se. All three treatments (N = 30/treatment) will be paired with both full or partial counseling conditions. Full counseling includes coping response training while partial counseling does not. Our previous research suggests that coping response training results in a large increase in long-term abstinence, but this finding requires replication and extension. Study 1 will include process measures that should reflect the acquisition of an aversion (e.g., heart rate & pulse-transit-time response to cigarettes) and coping skills. Outcome will be assessed by self- and collateral-report, and bioassays. Study 2 is intended to lead to an improved aversive smoking-cessation treatment. Four aversive smoking treatments will be compared, all of which will be paired with counseling: standard Rapid Smoking (RS), Parametrically superior Rapid Smoking (PRS), Imaginally enhanced Rapid Smoking (IRS), and Health Risk enhanced Rapid Smoking (HRRS). These treatments are designed to produce enhanced therapeutic effects through theoretically distinct routes. Also, two different maintenance strategies will be evaluated. One strategy is aimed at preventing any smoking. The second strategy is targeted at mitigating the effects of minor smoking episodes. Clinical outcome will be evaluated using techniques similar to those used in Study 1. Study 3 is designed to yield information on the conditions/stimuli that elicit self-report of urges to smoke and characteristic psychophysiological urge correlates. Urge-eliciting stimuli to be investigated include a laboratory stressor, gustatory attributes of cigarettes, and the pharmacological effects of cigarettes (drug priming). We hope that the resulting data will increase our understanding of how affect, physiological variables, and urge self-reports covary, and what theoretical urge models are most consistent with the pattern of covariation.
|
1 |
1994 — 1999 |
Baker, Timothy B |
R01Activity Code Description: To support a discrete, specified, circumscribed project to be performed by the named investigator(s) in an area representing his or her specific interest and competencies. |
Matching Patients to Smoking Treatments @ University of Wisconsin Madison
Smoking is the leading preventable cause of death and morbidity in the United States. The chief aim of this research is to demonstrate that particular kinds of smokers quit smoking more successfully with one treatment than another. Such a result would permit the optimal matching of smokers with cessation treatments and increase smoking treatment efficacy. The two smoking cessation treatments contrasted in this research are support counseling and skill training. These are frequently used treatments and are easy to implement. 560 smokers, stratified on their pretreatment affect, will be randomly assigned to one of four interventions: Skill training, Support counseling, combined Skill training and Support counseling, or an Attention/Placebo control condition. All subjects will receive the nicotine patch as an adjuvant. The three active- counseling treatments should produce significantly greater long-term abstinence than the control treatment. The most important predicted result is that subjects' pretreatment negative affect (mood) will interact with treatment type. Among subjects high in negative affect prior to treatment, Support counseling will produce better outcomes than any other treatment. Among subjects with little pretreatment negative affect, Skill training will produce better outcomes than any other treatment. Finally, this research will reveal the mechanisms by which the various treatments produce their beneficial effects, and materials will be developed that will promote the widespread use of the identified matching rules. Because quitting smoking has large health benefits, this research should reduce death and disease produced by smoking.
|
1 |
1996 — 1999 |
Baker, Timothy B |
R01Activity Code Description: To support a discrete, specified, circumscribed project to be performed by the named investigator(s) in an area representing his or her specific interest and competencies. |
Efficacy and Effectiveness of Nicotine Patch Adjuvants @ University of Wisconsin Madison
DESCRIPTION: (Applicant's Description) The ultimate goal of this research is to identify effective smoking cessation interventions appropriate in primary care settings that will reduce the morbidity and mortality caused by smoking-related disease. This study will evaluate the efficacy and effectiveness of the nicotine patch for smoking cessation when it is paired with three different intensities of psychosocial adjuvant. This research will identify the intensity of psychosocial adjuvant that maximizes the effectiveness, generalizability, cost-effectiveness, and durability of "real-world" clinical smoking cessation interventions. This study will occur in primary care clinics in two large managed care organizations serving diverse patient populations. The interventions will be implemented via a clinic-wide approach: every patient entering the clinic will be asked about smoking status during the vital signs assessment and all smokers will be offered cessation treatment. Thus, the interventions build upon existing clinic practices so that every smoker is offered a cessation intervention. Once smokers express an interest in quitting, they are randomly assigned to one of two treatment assignment strategies. In a phone call from a health educator, a patient will be offered treatment via either a Random N = 750) or Self-Selection (N = 750) strategy. In the Random strategy, the patient must accept one of three treatments to which s/he is randomly assigned. In the Self-Selection strategy, the patient receives information about the same three treatments and chooses one of them. The three cessation treatments.can be easily implemented in clinic settings: Patch Only (8 weeks of patch therapy), Patch + Low Intensity (patch therapy + personalized mailings and phone support), and Patch + High Intensity (patch therapy + personalized mailings and phone support + individual counseling). Abstinence rates will be assessed for one year post-treatment. The study assesses both the efficacy and effectiveness of psychosocial adjuvants to patch therapy. The Random strategy is that used by clinical trials (efficacy), whereas the Self-Selection strategy resembles clinic practice (effectiveness) where the patient has some choice over how s/he will stop smoking. The three cessation treatments may have very different outcomes in the two treatment assignment conditions. For instance, abstinence rates may differ greatly when smokers choose treatments vs. being assigned. Or, a treatment that produces high abstinence rates in randomly assigned subjects may have little potential public health benefit if smokers do not choose to enter it. Finally, cost-benefit profiles of the various cessation treatments will be estimated under the different assignment strategies.
|
1 |
1999 — 2002 |
Baker, Timothy B |
P50Activity Code Description: To support any part of the full range of research and development from very basic to clinical; may involve ancillary supportive activities such as protracted patient care necessary to the primary research or R&D effort. The spectrum of activities comprises a multidisciplinary attack on a specific disease entity or biomedical problem area. These grants differ from program project grants in that they are usually developed in response to an announcement of the programmatic needs of an Institute or Division and subsequently receive continuous attention from its staff. Centers may also serve as regional or national resources for special research purposes. |
Negative Affect in Relapse: Withdrawal and Treatment Medication @ University of Wisconsin Madison
DESCRIPTION: (Applicant's Description) Numerous smoking cessation treatments have been developed over the past 20 years. Unfortunately, these have not led to a notable increase in cessation rates over the same period. One impediment to a rational, empirically-based approach to smoking treatment is that we know very little about how effective treatments work. The proposed research will use Electronic Diaries (EDs; palmtop computers) to gather fine-grained, virtually real-time information on variables thought to mediate the effects of efficacious smoking cessation treatments. In addition, recent research suggests that tonic change in affect/withdrawal powerfully predicts relapse; this project will permit sensitive tests of this relation. In this research, 390 smokers motivated to quit will be randomized to one of three groups. In the Bupropion group, smokers will attempt to quit smoking with the aid of bupropion pharmacotherapy (150 mg b.i.d.). In the Combined condition, smokers will receive bupropion pharmacotherapy and will participate in group therapy sessions comprising therapeutic elements of known efficacy (i.e., social support and coping-skills training). A final group of smokers will be assigned to a Placebo condition; these subjects will not attend group sessions and will be given placebo pharmacotherapy. All subjects will use EDs to collect real-time information about urges, withdrawal, negative affect, smoking rates, etc -- during a 4-day period prior to the quit date and for the first 8 weeks of the cessation attempt. The study design allows for sensitive descriptive and predictive examinations of both short-term episodes and longer-term trends in theoretically prominent variables such as negative affect, withdrawal, stressors, temptations, and urges. It also permits tests of mediation to determine whether bupropion pharmacotherapy and/or counseling work through modifying the timing, frequency, trends, and/or severity of such variables.
|
1 |
2004 — 2008 |
Baker, Timothy B |
P50Activity Code Description: To support any part of the full range of research and development from very basic to clinical; may involve ancillary supportive activities such as protracted patient care necessary to the primary research or R&D effort. The spectrum of activities comprises a multidisciplinary attack on a specific disease entity or biomedical problem area. These grants differ from program project grants in that they are usually developed in response to an announcement of the programmatic needs of an Institute or Division and subsequently receive continuous attention from its staff. Centers may also serve as regional or national resources for special research purposes. |
Tobacco Dependence: Treatment and Outcomes @ University of Wisconsin Madison
Crucial knowledge gaps hinder our ability to treat nicotine dependence optimally. We know too little about the relative efficacies of pharmacotherapies in both clinical trials and real-world contexts. We know too little about how to deliver treatment: e.g., how to match patients with pharmacotherapies, how to incorporate treatment seamlessly into health care delivery systems and how to combine pharmacotherapies. In addition, we know too little about the global, long-term consequences of quit attempts: e.g., the downstream physiological, psychosocial, and health care utilization effects of continuing to smoke versus successfully quitting. Finally, we lack understanding of the mechanisms by which treatments work. These gaps will be addressed via four research projects and supportive cores. The first project (N=1520) will contrast efficacies of five different pharmacotherapies and a placebo, explore their mechanisms of action and yield algorithms for their optimal use. The second project will follow from the first project participants for at least 3 years and capture the diverse physical and psychosocial health outcomes of a quit attempt. The third project (N=1320) will study the active pharmacotherapies used in the first project, but in an effectiveness, primary care context. Data will address treatment utilization, success, and validate treatment algorithms. The fourth project will track from the third project subjects along with anonymous controls and reveal the impact of cessation on health care utilization and costs within a large network of primary care clinics. In addition, the UW-TTURC proposal includes an Administrative Core providing shared resources and infrastructure, a Career Development Core to increase the number of clinician-scientists entering the field of tobacco control research, and a Developmental Research Core to support innovative tobacco control research. The proposed work will advance the understanding and effectiveness of tobacco dependence treatment through integrated transdisciplinary research and result in more smokers quitting successfully.
|
1 |
2004 — 2008 |
Baker, Timothy B |
P50Activity Code Description: To support any part of the full range of research and development from very basic to clinical; may involve ancillary supportive activities such as protracted patient care necessary to the primary research or R&D effort. The spectrum of activities comprises a multidisciplinary attack on a specific disease entity or biomedical problem area. These grants differ from program project grants in that they are usually developed in response to an announcement of the programmatic needs of an Institute or Division and subsequently receive continuous attention from its staff. Centers may also serve as regional or national resources for special research purposes. |
Pharmacotherapies: Efficacy, Mechanisms, and Algorithms @ University of Wisconsin Madison
There are multiple efficacious pharmacotherapies for tobacco dependence, yet we still do not know: which medications work best, how best to match individuals to medications, how to combine medications, and how medications achieve their effects. These knowledge gaps are due, in part, to a lack of head-to-head comparisons of pharmacotherapies, including newer pharmacotherapies (e.g., the nicotine lozenge) and combinations of pharmacotherapies. In addition, clinicians and smokers have no scientifically based algorithms to guide the use of these medications because of the limited knowledge about which medications are most efficacious in particular populations of smokers. Also lacking are data that reveal how pharmacotherapies work, making it difficult to develop new pharmacotherapies on a rational basis. Participants (n = 1,520) will be randomly assigned to one of five medication conditions: nicotine patch, nicotine lozenge, bupropion, nicotine patch + nicotine lozenge, and bupropion + nicotine lozenge (n= 264/condition) and a placebo control condition (n=200). An extensive set of assessments will be collected from participants including: genotypes, personality, psychiatric symptoms and diagnoses, physiologic and medical status, diet, alcohol use/abuse, social relations, quality of life, exercise, smoking, withdrawal symptoms, stress, and nicotine dependence. These constructs will be assessed using psychometrically sound questionnaires, structured interviews, physical tests, and ecological momentary assessment (EMA). Assessments will serve three vital purposes: 1) to measure treatment outcomes (e.g., abstinence, withdrawa symptoms, weight gain); 2) to develop treatment matching algorithms based on individual differences (e.g., gender, level of dependence); and 3) to assess mechanisms of treatment effects (e.g., withdrawal suppression). In sum, this project will produce the best evidence to date on relative efficacies and mechanisms of action of cessation pharmacotherapies, and will provide algorithms to guide medication use.
|
1 |
2008 — 2012 |
Baker, Timothy B |
K05Activity Code Description: For the support of a research scientist qualified to pursue independent research which would extend the research program of the sponsoring institution, or to direct an essential part of this research program. |
Training in Translational Tobacco Science @ University of Wisconsin Madison
[unreadable] DESCRIPTION (provided by applicant): This K05 grant will provide training, educational, and research experiences that allow Dr. Timothy Baker to perform groundbreaking research, both transdisciplinary and translational, on tobacco use and other addictive disorders. Specifically, the research will foster the integration of theories, data, and methods from diverse disciplines and among many collaborators. In addition, it will permit him to conduct translational research in which innovative basic science models and methods are used to generate new treatments and assessments; viz. to facilitate the transfer of basic science findings and perspectives so that they achieve more effective real-world application. The requested support also will facilitate Dr. Baker's teaching and training of the future cadre of addiction scientists, especially physicians-in-training. To accomplish these aims, the applicant will: (1) use the requested support to reduce his administrative and teaching obligations; (2) take classes, engage in intensive reading and study, and consult with experts in targeted areas of special relevance to the applicant's research; (3) design and conduct new research studies that provide outstanding opportunity for transdisciplinary and translational research addressing tobacco use and other addictive disorders; and, (4) conduct on-going theory and methods training seminars and serve as a research mentor, with these efforts aimed especially at physicians-in-training. The proposed work will benefit from the tremendous resources available in the applicant's research environment and by his on-going research with a large transdisciplinary team. This K05 grant should benefit public health by enhancing the quality of research on addictive disorders performed by Dr. Baker, his collaborators, and those he trains. Specifically, this support should promote better understanding of tobacco use and other addictive disorders and, ultimately, impact the health of the nation by producing more effective treatments for these devastating, diseases. [unreadable] [unreadable] [unreadable]
|
1 |
2008 — 2012 |
Baker, Timothy B |
P50Activity Code Description: To support any part of the full range of research and development from very basic to clinical; may involve ancillary supportive activities such as protracted patient care necessary to the primary research or R&D effort. The spectrum of activities comprises a multidisciplinary attack on a specific disease entity or biomedical problem area. These grants differ from program project grants in that they are usually developed in response to an announcement of the programmatic needs of an Institute or Division and subsequently receive continuous attention from its staff. Centers may also serve as regional or national resources for special research purposes. |
Effectiveness of the Chess E-Health Cancer Support Intervention in Population-Bas @ University of Wisconsin Madison
Address; Affect; Anxiety; Businesses; Cancer Patient; Cancer of Breast; Cancers; Care, Health; Caring; Clinical; Communication; Competence; Computer Programs and Programming; Computerized Medical Record; Computers; Condition; Controlled Clinical Trials, Randomized; Data; Decision Making; Diagnosis; Disease; Disorder; Doctor-Patient Relations; Effectiveness; Electronic Medical Record; Emotional; Emotional well being; Family; Feels well; Fostering; Grant; Health; Health Care Costs; Health Care Providers; Health Care Utilization; Health Care Visit; Health Costs; Health Personnel; Healthcare; Healthcare Costs; Healthcare Providers; Healthcare Systems; Healthcare Visit; Healthcare worker; Internet; Intervention; Intervention Strategies; Knowledge; Learning; Letters; Malignant Neoplasms; Malignant Tumor; Malignant Tumor of the Breast; Malignant neoplasm of breast; Measures; Medical Record, Computerized; Medical Specialities; Mental well-being; Modeling; Normal mental condition; Normal mental state; Normal psyche; Numbers; Outcome; Outcome Measure; Patient Care; Patient Care Delivery; Patients; Phone; Physician Patient Relationship; Physician-Patient Relations; Population; Psychological Well Being; Randomized; Randomized Controlled Clinical Trials; Rate; Reaction; Relative; Relative (related person); Research; Research Resources; Resources; Self Management; Sense of well-being; Services; Site Visit; Social support; Specialties, Medical; Specialty; Sum; System; System, LOINC Axis 4; Systems, Health Care; Telephone; Training Support; WWW; Well in self; Woman; Work; behavior change; cancer care; cancer resource; computer program; computer programming; coping; cost; cost effectiveness; design; designing; disease/disorder; effectiveness research; efficacy trial; emotional distress; experience; feeling distress; feeling upset; health care personnel; health care service utilization; health care worker; health provider; health related quality of life; health services utilization; healthcare personnel; healthcare service utilization; healthcare utilization; improved; inclusion criteria; interest; interventional strategy; malignancy; malignant breast neoplasm; medical personnel; medical specialties; neoplasm resource; neoplasm/cancer; psychological wellness; randomisation; randomization; randomized trial; randomly assigned; self wellness; social support network; treatment provider; treatment utilization; volunteer; web; world wide web
|
1 |
2009 — 2013 |
Baker, Timothy B Collins, Linda M |
P50Activity Code Description: To support any part of the full range of research and development from very basic to clinical; may involve ancillary supportive activities such as protracted patient care necessary to the primary research or R&D effort. The spectrum of activities comprises a multidisciplinary attack on a specific disease entity or biomedical problem area. These grants differ from program project grants in that they are usually developed in response to an announcement of the programmatic needs of an Institute or Division and subsequently receive continuous attention from its staff. Centers may also serve as regional or national resources for special research purposes. |
Intervention Optimization Core @ University of Wisconsin-Madison
A primary objective of the proposed center is to establish a laboratory for ongoing optimization of a comprehensive smoking cessation intervention. Our definition of intervention optimization is: Employing scientific theory and efficient methodology to produce an evidence-based intervention that represents the maximal improvement in effectiveness, translatability and/or cost-effectiveness over currently available interventions. In the proposed center we plan to approach intervention optimization by using an innovative optimization cycle framework inspired by engineering methods. The optimization cycle is an extension and elaboration of the Multiphase Optimization Strategy (MOST), a phased experimental approach to intervention development and optimization developed by Collins, Murphy, Nair, and Strecher1 2. Potential advantages of using the, optimization cycle framework include: It is a systematic and principled approach, and therefore is the fastest way, in the long run, to an appreciably improved smoking cessation intervention; it provides a straightforward way of testing hypotheses about potential new intervention components or changes to existing components; it provides a natural way of including cost information in the basis for decision making about intervention development; and it will help contribute to the building of a coherent cumulative base of scientific knowledge about smoking cessation. The Intervention Optimization Core has four Specific Aims: (1) to serve as an intellectual resource to the center, providing ongoing input on the innovative optimization cycle framework and related statistical and methodological consultation as needed; (2) to conduct original methodological work to refine the optimization cycle approach, based on issues that arise in the course of the proposed optimization cycle; (3) to disseminate information about the optimization cycle approach to drug abuse prevention and treatment scientists, using the work of the proposed center as an illustration; and (4) to conduct exploratory analyses in preparation for a second optimization cycle, in collaboration with the Methods Core.
|
1 |
2009 — 2013 |
Baker, Timothy B |
P50Activity Code Description: To support any part of the full range of research and development from very basic to clinical; may involve ancillary supportive activities such as protracted patient care necessary to the primary research or R&D effort. The spectrum of activities comprises a multidisciplinary attack on a specific disease entity or biomedical problem area. These grants differ from program project grants in that they are usually developed in response to an announcement of the programmatic needs of an Institute or Division and subsequently receive continuous attention from its staff. Centers may also serve as regional or national resources for special research purposes. |
Identifying Optimal, Translatable Tobacco Cessation Interention Components @ University of Wisconsin-Madison
The proposed research is designed to identify optimal cessation intervention components across three phases of the cessation process: Precessation, Pericessation, and Maintenance. Project 1 comprises two experiments that are based on the Center-wide intervention optimization approach that relies upon factorial designs and sequential experiments to efficiently engineer and evaluate interventions (Collins et al., 2005, 2007). The specific aim of Experiment 1 a is to determine the optimal intervention strategies to use in the first 2 weeks following the quit day (the Pericessation Phase). Three factors will be tested in a factorial design: varenicline vs. placebo pill; clinician cessation counseling (minimal vs. intensive); and phone counseling (minimal vs. intensive). Experiment 1 a will determine which combination of these components produces optimal effects on measures of mechanism and outcome. The placebo pill condition allows for the demonstration of varenicline efficacy and permits the examination of intervention mechanisms. The specific aim of Experiment 1b is to examine Precessation and Maintenance Phase (postquit week 3 to 6 months) interventions, when used in combination with the optimal Pericessation strategy identified from Experiment 1a. Four factors will be tested in a factorial design: extended (3 weeks) Precessation varenicline vs. standard 1 week of Precessation varenicline; enhanced Precessation counseling (3 sessions) vs. minimal Precessation counseling (one session); extended Maintenance use of varenicline (25 weeks) vs. standard 13 weeks of varenicline; and extended counseling (5 phone sessions) vs. no additional counseling. Experiment 1 b will determine which of these Precessation and Maintenance intervention components produce optimal effects on measures of mechanism and outcome. The ultimate goal of this research is to engineer an optimal, comprehensive smoking cessation intervention package. The best Precessation, Pericessation and Maintenance intervention components will be selected based upon an appraisal of statistical significance, effect size, cost-effectiveness and other evaluative criteria.
|
1 |
2009 — 2013 |
Baker, Timothy B Fiore, Michael C |
P50Activity Code Description: To support any part of the full range of research and development from very basic to clinical; may involve ancillary supportive activities such as protracted patient care necessary to the primary research or R&D effort. The spectrum of activities comprises a multidisciplinary attack on a specific disease entity or biomedical problem area. These grants differ from program project grants in that they are usually developed in response to an announcement of the programmatic needs of an Institute or Division and subsequently receive continuous attention from its staff. Centers may also serve as regional or national resources for special research purposes. |
Engineering Effective Interventions For Tobacco Use: a Translational Laboratory @ University of Wisconsin-Madison
DESCRIPTION (provided by applicant): Tobacco use exacts an enormous toll on the health of America, with prevalence stalled at about 20% of all adults. Further reductions in smoking prevalence are impeded by several factors: (1) slow progress in the development of more effective cessation interventions;(2) low utilization of evidence-based interventions;and (3) ineffective use of interventions. The primary objective of the proposed Center is to establish a multidisciplinary laboratory designed to yield a comprehensive (individual to systems-level) smoking cessation intervention. This NIDA Center of Excellence application includes three research projects supported by four cores that together will produce a translatable, cost-effective, and clinically effective smoking cessation intervention package. The overall methodological approach is guided by the principles of intervention optimization. Project 1 will test multiple, evidence-based intervention components, administered at different phases of the cessation attempt, to identify the combination of components that produces optimal smoking cessation success. Project 2 will test two different types of clinician interventions that are prompted by the electronic medical record and designed to increase smokers'use of evidence-based cessation interventions. Project 3 will test three different types of interventions designed to increase smokers'effective use of cessation medication. In support of the research projects, the Center will create four cores: Administrative, Intervention Optimization, Methods, and Mentoring, Education, and Dissemination. These will provide the administrative, scientific, educational, and operational support needed to ensure the success of the research projects and the Center as a whole. Overall, this proposed Center of Excellence is designed to demonstrate the value of innovative, mutidisciplinary research strategies in producing optimal cessation packages;these strategies can be applied to diverse problems in health and drug abuse. The overarching goal of this Center of Excellence application is to reduce the prevalence of tobacco use in the United States, and the resulting burden of illness, death, and cost. PUBLIC HEALTH RELEVANCE: The health, economic, and human costs of tobacco use are profound. The proposed Center grant will bring together scientists from different fields to develop highly effective approaches to smoking cessation treatments and to ensure that they are used in clinics and healthcare settings. This integrated approach is expected to yield greatly improved population-wide reductions in smoking.
|
1 |
2014 — 2018 |
Baker, Timothy B |
P01Activity Code Description: For the support of a broadly based, multidisciplinary, often long-term research program which has a specific major objective or a basic theme. A program project generally involves the organized efforts of relatively large groups, members of which are conducting research projects designed to elucidate the various aspects or components of this objective. Each research project is usually under the leadership of an established investigator. The grant can provide support for certain basic resources used by these groups in the program, including clinical components, the sharing of which facilitates the total research effort. A program project is directed toward a range of problems having a central research focus, in contrast to the usually narrower thrust of the traditional research project. Each project supported through this mechanism should contribute or be directly related to the common theme of the total research effort. These scientifically meritorious projects should demonstrate an essential element of unity and interdependence, i.e., a system of research activities and projects directed toward a well-defined research program goal. |
Testing Relapse Recovery Intervention Components @ University of Wisconsin-Madison
Smoking is the leading preventable cause of cancer mortality in the US, making improved smoking treatment a vital public health goal. However, most smokers trying to quit ultimately relapse, and little is known about how to treat them. This project is designed to identify highly effective intervention components for recently relapsed smokers that can be included in a chronic care treatment for smoking that comprises effective intervention components for every phase of smoking treatment and that is feasible for use in healthcare settings. Participants from Project 3 of this POI application (the Cessation RCT) who relapse will transition to this Relapse Recovery project (N~776). Three intervention factors (each comparing an enhanced intervention component with a standard one) will be tested using a factorial Sequential Multiple Assignment Randomized Trial (SMART) design. All participants will be randomized to a Preparation factor comparing two strategies for preparing relapsers to requit. However, only participants choosing to make a new quit attempt will be randomized to the two Cessation factors: 1) Personalized vs. Regular Cessation Medication, and 2) Front-loaded vs. Regular Cessation Counseling. The enhanced Preparation and Cessation intervention components are designed to address the major challenges facing relapsers. The enhanced Preparation component (Smoking Reduction Counseling) is designed to counter demoralization and reduce tobacco dependence. Personalized Cessation Medication is designed to increase medication adherence and reduce withdrawal craving during a quit attempt, while Front-loaded Cessation Counseling is designed to reduce early lapsing by providing support and skills training early in the quit attempt. Analyses will determine the main and interactive effects of the two Cessation factors on smoking abstinence and determine whether these effects differ as a function of the Preparation factor. Analyses will also determine the effects of the Preparation factor on the likelihood of a meaningful quit attempt. The proposed research will be the first comparative effectiveness research to evaluate novel but promising Relapse Recovery intervention components in healthcare settings thus facilitating their rapid translation to real-world use.
|
1 |
2017 — 2020 |
Baker, Timothy B Stein, James H |
R01Activity Code Description: To support a discrete, specified, circumscribed project to be performed by the named investigator(s) in an area representing his or her specific interest and competencies. |
Enhancing the Effectiveness of Varenicline Based Smoking Cessation Treatment @ University of Wisconsin-Madison
PROJECT SUMMARY/ABSTRACT Cigarette smoking remains the chief preventable cause of cardiovascular and pulmonary disease. While evidence-based treatments improve a smoker?s chances of quitting successfully, even with such treatments, the majority of smokers still fail to quit long-term in a given quit attempt. There is a clear need for more effective treatments. The proposed research would evaluate two treatment modifications that are designed to enhance the effectiveness of varenicline, an FDA-approved smoking cessation medication: 1) extending the duration of varenicline treatment; and 2) adding the nicotine mini-lozenge to varenicline to form a combined treatment. While existing data suggest that both modifications may substantially enhance varenicline effectiveness, neither has been adequately tested. The proposed research will use a 2X2 factorial design to randomize 1000 smokers to one of two levels of each of two factors: Duration (12- vs. 24-weeks of medication) and Adjuvant (varenicline + placebo lozenge vs. varenicline + nicotine mini-lozenge). Thus, smokers will receive either standard varenicline treatment (12 weeks of varenicline therapy) or 1 of 3 innovative, enhanced treatments: 12 weeks of varenicline + mini-lozenge, 24 weeks of extended treatment with varenicline only, or 24 weeks of extended treatment with varenicline + mini-lozenge. Analyses will reveal whether the Duration and Adjuvant modifications produce additive or interactive effects on smoking abstinence at 52 weeks postquit, the primary outcome. Also, planned comparisons will determine if any of the enhanced conditions is superior to standard varenicline therapy. The hypothesis is that 24-week duration and the mini-lozenge adjuvant will produce significant, additive main effects so that their combination (24-weeks of varenicline + mini-lozenge) produces higher abstinence rates at 52-weeks postquit than does standard 12-week varenicline treatment. Other outcomes include prolonged smoking abstinence, treatment cost-effectiveness, withdrawal suppression, and adverse events. In sum, this research is designed to produce an especially effective smoking cessation treatment that should increase the rate of pharmacologic intervention with smokers in healthcare, reduce smoking prevalence in patient populations, and reduce incidence of cardiovascular and pulmonary disease.
|
1 |
2018 — 2021 |
Baker, Timothy B Stein, James H |
R01Activity Code Description: To support a discrete, specified, circumscribed project to be performed by the named investigator(s) in an area representing his or her specific interest and competencies. |
E-Cigarette Effects On Markers of Cardiovascular and Pulmonary Disease Risk @ University of Wisconsin-Madison
Project Summary/Abstract E-cigarette use is increasing rapidly in the United States, especially amongst youth, underscoring the vital need to improve understanding of its health risks. Relevant data could inform policy, guide public health and clinical intervention efforts, and inform individuals who might use or who are using this product. In this proposal, we describe research that will significantly enhance our understanding of the health effects of E-cig use by relating the acute and long-term use of E-cigs and conventional cigarettes (?products?) to well- validated cardiovascular and pulmonary disease biomarkers. We will enroll 4 different ?use-groups? of participants (n=440): exclusive E-cig users (n=110), exclusive cigarette smokers (n=110), dual product users (who both smoke and vape: n=110), and never smokers (n=110). These groups reflect the primary decisions that individuals can make regarding their future tobacco use: to continue to smoke cigarettes, to switch to E- cigs, to use both cigarettes and E-cigs, or to not use products. It is essential that smokers and health care providers have accurate information on the health effect of these choices. Product use will be related to well-validated biomarkers that accurately and reproducibly reflect mechanisms, injury, and future risks related to cardiovascular or pulmonary disease. Biomarkers will be related to (1) acute product use in the laboratory (exposure challenges), (2) lifetime history of product use, and/or (3) real-time measures of product use in participants' daily lives. The primary cardiovascular biomarkers are brachial artery flow-mediated dilation (a measure of endothelial function) and carotid intima-media thickness, a measure of subclinical arterial injury and atherosclerosis. The primary pulmonary disease biomarkers will be measures of lung volumes and flow rates (predicted FEV1, FVC, FEV1/FVC) obtained by spirometry. We also will perform treadmill exercise stress testing (to assess aerobic fitness), electrocardiography (to measure heart rate and its variability) and measure blood pressure, lipids, HgbA1c, and inflammation/oxidation markers (leukocyte count, C-reactive protein, urinary F2 isoprostanes) and exhaled nitric oxide. We will show how product use-groups differ in response to (1) acute product use and (2) long-term use regarding cardiovascular and pulmonary biomarkers. We also will determine how history of product use is related to biomarker status. The proposed research will yield vital and comprehensive data regarding product use, subclinical arterial injury, atherosclerosis burden, arterial and pulmonary function, cardiac and aerobic fitness, cardiac autonomic dysregulation, systemic and pulmonary inflammation, and oxidative stress, as well as other key outcomes. These data will serve as a foundation for future longitudinal investigations of E-cig health effects and will inform public policy decisions, clinical interventions, and patient guidance regarding E-cigarettes.
|
1 |
2019 — 2021 |
Baker, Timothy B Fiore, Michael C |
P01Activity Code Description: For the support of a broadly based, multidisciplinary, often long-term research program which has a specific major objective or a basic theme. A program project generally involves the organized efforts of relatively large groups, members of which are conducting research projects designed to elucidate the various aspects or components of this objective. Each research project is usually under the leadership of an established investigator. The grant can provide support for certain basic resources used by these groups in the program, including clinical components, the sharing of which facilitates the total research effort. A program project is directed toward a range of problems having a central research focus, in contrast to the usually narrower thrust of the traditional research project. Each project supported through this mechanism should contribute or be directly related to the common theme of the total research effort. These scientifically meritorious projects should demonstrate an essential element of unity and interdependence, i.e., a system of research activities and projects directed toward a well-defined research program goal. |
Optimized Chronic Care For Smokers: Developing and Implementing Integrated Clinical and Systems Interventions in Primary Care @ University of Wisconsin-Madison
Overall Summary Tobacco smoking is the leading preventable cause of cancer death. However, healthcare systems have not realized their potential to reduce smoking prevalence; far too few patients who smoke are offered and use smoking treatments and such treatments are insufficiently effective. This Program Project addresses these key obstacles by developing an especially effective comprehensive chronic care smoking treatment to reduce smoking prevalence in healthcare via 4 individual projects and 3 cores. This Program Project will balance internal and external validity via powerful, innovative research methods such as the Multiphase Optimization Strategy (MOST) while also using real-world primary care clinics, patients, and staff, and using the RE-AIM framework to enhance its public health impact. Using a factorial design, the Cessation Screening Project will evaluate four experimental factors in 608 smokers willing to quit to determine, for the first time, which intervention strategies (Preparation Medication, Extended Medication, and Counseling Modality) combine to produce especially effective Optimized Varenicline and Combination Nicotine Replacement Therapy (C-NRT) Treatment Packages based on cost and 1-year abstinence. The Health System Reach Interventions Project will, for the first time, use a factorial experiment to evaluate three interventions intended to increase the use of cessation treatments (i.e., reach) over 2 years in 1664 smokers initially unwilling to quit: 1) Monetary Incentives to Use Smoking Treatment, 2) Electronic Health Record (EHR) Based Automated Tailored Outreach, and 3) Care Management. An Optimized Reach Intervention Package will be developed that produces especially high rates of varenicline and C-NRT cessation treatment use by smokers initially unwilling to quit. The Optimized Care Project will comprise two randomized controlled trials (RCTs) that evaluate the Optimized Cessation and Reach Intervention Packages developed in the Cessation and Reach Projects. One RCT will compare Optimized Cessation Treatment versus Standard Care (physician & quitline referral) on 1-year abstinence in 600 smokers willing to quit. The second RCT will compare combined Optimized Reach and Cessation Interventions versus Standard Care on cessation treatment use and 1-year abstinence in 900 smokers initially unwilling to quit. The Implementation Project will assess the reach, implementation (fidelity, adaptation, relation with effectiveness), patient representativeness, and maintenance of interventions in the other 3 projects using EHR, survey, qualitative, and observational data at patient, staff, clinic, and system levels. This Program Project will be supported by Administration & Logistics, Data Analysis, and Optimization Cores and by shared resources: collaborating healthcare systems and recruitment via an enhanced EHR. This Program Project will develop a chronic care smoking treatment for healthcare that includes optimized reach and cessation interventions that can be readily implemented and disseminated and that markedly increase the use and effectiveness of cessation treatment, ultimately reducing smoking prevalence and cancer deaths.
|
1 |