Robin Mermelstein - US grants

The general objective is to test, in a controlled (randomized) experimental field study in a defined population, the relative and overall effectiveness of different approaches to implementing a comprehensive and integrated smoking prevention/cessation program designed to reduce the number of children who will become cigarette smokers and to encourage current smoking adults and students to reduce or quit smoking. Targeted primarily at school age children and their families, the program is composed of four integrated components: five 5-minute TV segments on smoking prevention aired on commercial TV each evening for one week during the early evening news hour; five corresponding 45-60 minute classroom sessions delivered to grade 7 and 8 health education classes during the same week; encouragement of family involvement by the use of homework assignments and provided written materials; and five 5-minute segments the following week on smoking cessation targeted at all smokers, but particularly at smoking students and parents. The program is comprehensive in that while if focusses on developing an awareness of the social pressures to smoke and providing the behavioral skills needed to resist such pressures, it also provides information on both physiological and social effects of smoking as well as the long-term health consequences, and teaches decision making skills so that adolescents can reach informed decisions about their behavior. The proposed research calls for three types of studies. Implementation/process evaluation (manipulation checks) will determine the integrity and strength of the program as implemented under various conditions. School based experimental and quasi-experimental studies will determine the effects of the program on beliefs, attitudes, intentions, and smoking behavior of grade 7 and 8 children and their parents. Components of the design will determine the effects of the program and its various components, and the cost-effectiveness of providing special training to teachers. Samples of other adults will be surveyed to determine the effects of the program on adults without grade 7 and 8 children, as well as their level of involvement in the program. Random assignment of some parents and requesters to receive a phone-in maintenance program will determine the efficacy and cost-effectiveness of such a strategy for preventing relapse by quitters.

The aims of this research are to: 1) assess the long-term effectiveness of a successful smoking prevention program; 2) explore the differential pattern of program effects over time; 3) complete more in-depth analyses of whom the program affected and whom it did not affect, especially over time; 4) assess the effects of repeated testing on students not exposed to a smoking prevention program; and 5) assess [program effects on the reported level of smoking by parents, siblings, and friends of students exposed to the program. These aims will be met by the collection of five- and six-year follow-up data from students who participated in the original Waterloo Smoking Prevention Study and a comparable sample of same-age students not included in the original study. The Waterloo Study worth long-term follow-up because it represents the strongest test to date of the social influences approach to smoking prevention. A large enough number of schools were assigned (mostly on a random basis) to ensure (a) pretest comparability, and (b) that the classroom (the unit of intervention) could be used as the unit of analysis (at least for major tests of program effectiveness). Results up to 2 1/2 years after the core intervention demonstrated that the Waterloo program was at least as effective as others that have been reported in the literature. This follow-up study will be conducted at two sites: data will be collected and some preliminary and nonparametric analyses will be conducted at the University of Waterloo by the Co-P.I. and Co-Investigators (on a subcontract-consortium basis), but the bulk of the statistical analyses and report generation will be conducted at the University of Southern California by the P.I. and staff of the Health Behavior Research Institute.

The general aim of the proposed research is to study the process of recycling participants in a smoking cessation program who either fail to quit or who quit and relapse. Recycling unsuccessful attempters and relapses into additional treatment regimens is especially critical for those who despite having lung disease, have still not been able to achieve permanent abstinence. Cigarette smoking is the primary contributing factor to lung cancer deaths and the major cause of chronic obstructive lung disease in the U.S. for both men and women. For many smokers, relapse is a frequent and expected stage in smoking cessation, and multiple attempts are needed to achieve long-term success. In the proposed research, 500 smokers will be randomly assigned to one of two treatment conditions: Standard treatment or Recycling. Treatment for both will consist of 7 weekly group sessions followed by 8 counselor- led phone calls. Differences between the two conditions will occur in the content of the phone calls. In the Recycling condition unsuccessful attempters and relapses will receive a multicomponent package aimed at helping them to re-achieve abstinence. The Standard treatment subjects will receive an attention-control treatment during the phone calls. Follow-up data, including biochemical verification of abstinence, will be collected 3, 6, and 12 months after the last phone call. We hypothesize that more attempters and relapses in the Recycling condition will achieve a subsequent quit episode, will do so sooner, and will have higher rates of abstinence during the follow-ups than subjects in the Standard condition. We will also examine the roles of several psychosocial variables in the recycling process and the extent to which they are related to subjects' recycling efforts and successes. These include adherence to the recycling program, self- efficacy, coping attempts, social support, and negative affect. Finally, we will conduct separate statistical analyses to determine the effects of the intervention on subsamples of subjects who are either at high risk for or who suffer from lung disease. Information about pulmonary functioning and respiratory symptoms will be collected from all subjects.

The overall objective of this research is to improve our understanding of why adolescents start to use tobacco, alcohol, marijuana and other drugs, both over the counter (OTC) and illicit, and why some subsequently become problem users and abusers. The specific objectives and aims are as follows: 1) Collect two more waves of predictor and drug use data, at grade 11 and two years later, from a cohort of Southern California students on whom we already have up to three waves (grades 7-9 of self-report, parent, and school personnel data (N=4450). An additional 4000 students will be surveyed at grade 11; a sample of 1250 of these students who score the highest on a multivariate risk factor will also be followed two years later. The grade 11 will be collected in Southern California high schools by USC staff during year 01, and the final wave of data will be collected by mail or phone by the UIC Survey Research Lab in the spring of 1992 (year 03 of the grant). 2) Investigate the role of family variables and adolescent mental health in the onset of drug abuse. This work will be conducted mostly at USC. Specific aims regarding this objective include assessing the importance of latchkey status as a predictor of drug abuse in a multivariate context, investigating the relationship between latchkey status and other indicators of conventional social bonding, and examining the relationship between latchkey status and depression and their prediction of drug use. 3) Compare the goodness of fit of alternative explanatory theories of the onset of drug use and abuse. This work will be conducted at UIC. The specific aims within this objective include assessing the robustness and stability of junior high school student and parent predictors thorough post high school, comparing the goodness of fit of several alternative predictive theories of drug use and abuse, examining the relationships between micro- and macro-level predictors from various theories, and developing and testing the goodness of fit of an "optimum" integrated model. The proposed study is important because it: encompasses the high risk age range (12-18); includes data from parents (grade 7-9) and schools (grades 7-9 & 11); enables tests and contrasts of the most important of the existing theories; incorporates a wider range of variables than any other single study; includes data from an ethnically and socioeconomically diverse population; includes five waves of data; utilizes sophisticated analytical techniques to examine interactions and mediating relationships and to contrast models; has a large enough sample size to enable split-half testing and replication for all analyses; will have important implications for future prevention programs/research.

We propose a Predoctoral and a Postdoctoral Training Program in Cancer Prevention and Control (CPC) Research at the University of Illinois at Chicago (UIC). The training programs will be located in the School of Public Health -- the predoctoral program in the Division of Community Health Sciences (CHS) and the postdoctoral program in the Prevention Research Center. We will admit one new predoctoral trainee per year and two postdoctoral fellows. The postdoctoral fellows will be evenly divided between PhDs and MDs. Predoctoral trainees will be expected to complete a PhD in the Health Promotion track of CHS, with an emphasis in CPC research. Courses are required in the following areas: cancer biology, treatment and control; cancer epidemiology; statistics and research methods; and behavioral sciences and health promotion. All trainees will complete a Cancer Prevention/Control Rotation, during which they will acquire the skills to develop, implement and evaluate behavioral interventions. They will also attend a Prevention Research Seminar Series every semester of their program at which UIC and visiting faculty present their research. Finally, they will complete a dissertation based on independent research. The program is expected to take three years, and longer for some who need more prerequisites than others. In the postdoctoral training program, the emphasis is on fellows working with faculty on ongoing CPC research projects and developing their own research program. However, postdoctoral fellows will be expected to also complete several core courses to ensure that they have 1) basic knowledge of cancer biology, epidemiology, treatment and control, 2) skills in research methods and statistics, and 3) skills in behavioral intervention design, implementation and evaluation. The amount of coursework required will be tailored for each fellow, depending on their background. Fellows with PhDs in the behavioral sciences may need only the cancer content and improvement of their research or intervention skills. Fellows with an MD may require extensive education in research methods and the behavioral sciences, as well as some improvement of their knowledge of cancer. Thus, we expect that MDs will spend three years in the postdoctoral program, while many PhD fellows may complete the program in two years. UIC faculty are very active in CPC research, with 33 faculty currently conducting CPC research. We have formed a Cancer Education Committee of 13 faculty most active in CPC research; 29 other faculty will contribute to the training program. The Director of the program will be Dr. Brian R. Flay, D.Phil., whose work in smoking and drug abuse prevention, and on the use of mass media for smoking cessation is well known. CEC faculty have extensive experience in training for cancer prevention and control research. UIC provides a particularly rich training environment because participating faculty have been very successful in attracting research funds from NCI and many other Federal and non-Federal agencies. Active research addresses all anatomical sites of cancer, and emphasizes behavioral approaches to 1) prevention and 2) early detection and screening.

We propose a Predoctoral and a Postdoctoral Training Program in Cancer Prevention and Control (CPC) Research at the University of Illinois at Chicago (UIC). The training programs will be located in the School of Public Health -- the predoctoral program in the Division of Community Health Sciences (CHS) and the postdoctoral program in the Prevention Research Center. We will admit one new predoctoral trainee per year and two postdoctoral fellows. The postdoctoral fellows will be evenly divided between PhDs and MDs. Predoctoral trainees will be expected to complete a PhD in the Health Promotion track of CHS, with an emphasis in CPC research. Courses are required in the following areas: cancer biology, treatment and control; cancer epidemiology; statistics and research methods; and behavioral sciences and health promotion. All trainees will complete a Cancer Prevention/Control Rotation, during which they will acquire the skills to develop, implement and evaluate behavioral interventions. They will also attend a Prevention Research Seminar Series every semester of their program at which UIC and visiting faculty present their research. Finally, they will complete a dissertation based on independent research. The program is expected to take three years, and longer for some who need more prerequisites than others. In the postdoctoral training program, the emphasis is on fellows working with faculty on ongoing CPC research projects and developing their own research program. However, postdoctoral fellows will be expected to also complete several core courses to ensure that they have 1) basic knowledge of cancer biology, epidemiology, treatment and control, 2) skills in research methods and statistics, and 3) skills in behavioral intervention design, implementation and evaluation. The amount of coursework required will be tailored for each fellow, depending on their background. Fellows with PhDs in the behavioral sciences may need only the cancer content and improvement of their research or intervention skills. Fellows with an MD may require extensive education in research methods and the behavioral sciences, as well as some improvement of their knowledge of cancer. Thus, we expect that MDs will spend three years in the postdoctoral program, while many PhD fellows may complete the program in two years. UIC faculty are very active in CPC research, with 33 faculty currently conducting CPC research. We have formed a Cancer Education Committee of 13 faculty most active in CPC research; 29 other faculty will contribute to the training program. The Director of the program will be Dr. Brian R. Flay, D.Phil., whose work in smoking and drug abuse prevention, and on the use of mass media for smoking cessation is well known. CEC faculty have extensive experience in training for cancer prevention and control research. UIC provides a particularly rich training environment because participating faculty have been very successful in attracting research funds from NCI and many other Federal and non-Federal agencies. Active research addresses all anatomical sites of cancer, and emphasizes behavioral approaches to 1) prevention and 2) early detection and screening.

The purpose of this project is to develop and evaluate strategies for the primary prevention of skin cancer. Skin cancers are the most common cancers today. Primary prevention, aimed at reducing unprotected sun exposure, is the best way to curb the rising skin cancer incidence rates. Most importantly, epidemiological evidence suggests that prevention efforts should focus on children and adolescents. This proposal contains two studies. The primary aim of study 1, "Skin Cancer Prevention for Adolescents," is to develop and evaluate the efficacy of an intervention that uses motivation and efficacy building strategies to increase the sun protection practices of high school students. Ten high schools with primarily a white student population will be randomly assigned to one of two conditions. The Basic Condition will employ an informational based classroom intervention. The Enhanced Condition will add components to the Basic intervention that are designed to influence more specifically motivation, perceptions of social norms favoring sun protection, and efficacy for using protection. We hypothesize that adolescents in the Enhanced condition, as compared to the Basic, will report more favorable attitudes toward sun protection and will show greater increases in measures of protection: use of sunscreen, protective clothing (hats), and shade. We will have multiple indicators of behavior change, including self-reports and requests for sunscreen and hats. Effects of the intervention will be measured over two summers. The overall aim of study 2," Skin Cancer Prevention Intervention with Day Care Providers," is to increase the suns protection practices of children's caregivers. Day care providers play an increasingly important role in our society, not only in caring for children, but also as serving as informational resources for parents. The primary aim of study 2 is to develop and evaluate a multi-component intervention for day care providers that is based on motivation and compliance enhancement strategies. Twenty-four day care centers will be matched on center characteristics and then randomly assigned to one of two conditions: Basic (information only) an Enhanced (motivation and compliance building). We hypothesize that caregivers in the Enhanced condition, as compared to the Basic, will more frequently advise parents about the need to use sun protection with their children and more frequently use sun protection for children under their care. Secondary aims include examining the effects of the intervention on the day care providers use of sun protection for themselves, and examining the role of organizational and psychosocial factors in providers' protection practices. We will have multiple measures of provider behavior including self-report, parent report, and behavioral observations.

DESCRIPTION: (Applicant's Description) The broad, long-term objective of this proposal is to increase our understanding of how adolescent's subjective experience of early trials of cigarette smoking impacts upon their future smoking behavior. The Specific Aims are 1) to increase our understanding of the subjective and objective microcontexts of adolescent smoking and how they vary by age and gender, 2) to describe adolescents' patterns of acceleration and deceleration in the frequency, intensity and regularity of smoking, and 3) to determine which micro- and macro-level factors differentiate youth who eventually either escalate, maintain, or discontinue their smoking. The research design follows youths ranging widely in their smoking behavior (from recent tryers to weekend smokers), cross-sectioned by grade (8th- 10th), at semi-annual intervals for a period of 18 months. During each data collection period adolescents will provide 1) intensive naturalistic self-reports on their daily experience and smoking behavior for one week and 2) retrospective questionnaire and interview data. Employing hand-held computer self-monitoring devices, we will use a combination of random time-sampling and event sampling while adolescents go about their daily lives to capture both smoking episodes and comparison events. This ecologically valid yet systematically collected data, Capturing thousands of moments nested in 240 adolescents, can provide a heretofore unseen picture of the subjective experience of adolescent smokers and examine its relationship to changes in smoking patterns. Findings from this study have potential for informing both smoking cessation and preventive interventions for adolescents.

Despite almost three decades of attention to the problem of adolescent smoking, relatively little attention has been paid to addressing the question of how adolescents progress from experimentation to subsequent stages of use, and what predicts transitions up or down at each level. The overall goal of this program project is to increase our understanding of the patterns of adolescent smoking. Our hope is to track the natural history of these patterns and to examine in-depth some key, selected contextual factors that may influence them. Our focus is on the social-emotional contexts with an emphasis on depression, anxiety, problem behaviors, and positive affective domains. As a program project, we will examine the intersections of these social and emotional domains. The cornerstone of this program project is the establishment and maintenance of a high-quality cohort of adolescents. Our design in establishing this cohort draws on elements of both epidemiology and developmental psychology, and may be thought of as an "accelerated developmental trajectory of smoking." We will develop our sample in a planned way, maximizing our ability to study movement across levels or stages of smoking. Our program project comprises three research projects and three cores. The three research projects are: 1) Proximal Contexts of Adolescent Smoking Patterns (Robin Mermelstein, P.I.); 2) Developmental influences on Adolescent Smoking Patterns (Lauren Wakschlag, P.I.); and 3) Smoking's Effect on Emotion in Adolescent Smokers (Jon Kassel, P.I.). All three projects utilize a common core cohort to test broad-based hypotheses, and in addition, each project utilizes a state-of-the-art, in-depth measurement modality to examine intensively key constructs on a sub-sample of the cohort. Across the projects, we will use a combination of ecological momentary assessments through the use of hand-held computers (Project 0001), family observations of parent-adolescent discussions and interactions (Project 0008), and psychophysiological reactions of adolescents to smoking in controlled laboratory settings (Project 0003). State-of-the-art analytic techniques will explore the intersections of these variables. We will have three cores. The cores allow us to develop a series of integrated, cross-project analyses and papers that address how combinations of variables across projects (e.g., family, peer, situational/contextual, emotional) conjoin with each other in producing the patterns of adolescent smoking from experimentation onward. These cores will support the basic functions of the program project, including the establishment and maintenance of the cohort. The three cores are: A) Scientific/Administrative Core (Robin Mermelstein, Director); B) Recruitment and Retention Core (Susan Curry, Director); and C) Data Management, Measurement, and Statistics Core (Donald Hedeker, Director).

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Address; Adolescent; Adolescent Development; Adolescent Youth; Advisory Committees; Applications Grants; Area; Authorship; Budgets; Climate; Collaborations; Communication; Development; Documentation; Ensure; Environment; Grant Proposals; Grants, Applications; Human Resources; Infrastructure; Institution; Interdisciplinary Research; Interdisciplinary Study; Internet; Investigators; Leadership; Manpower; Mentors; Meteorological Climate; Multidisciplinary Collaboration; Multidisciplinary Research; Operation; Operative Procedures; Operative Surgical Procedures; Parents; Peer Review; Persons; Pilot Projects; Policies; Postdoc; Postdoctoral Fellow; Principal Investigator; Procedures; Productivity; Programs (PT); Programs [Publication Type]; Publications; Quality Control; Questionnaires; Research; Research Activity; Research Associate; Research Infrastructure; Research Personnel; Researchers; Review Literature; Scientific Publication; Site; Structure; Students; Study, Interdisciplinary; Surgical; Surgical Interventions; Surgical Procedure; Task Forces; Tobacco Consumption; Tobacco use; WWW; Work; adolescent smoking; career; climatic; cohort; conference; dissemination research; interest; juvenile; juvenile human; personnel; pilot study; post-doc; post-doctoral; programs; surgery; symposium; web; world wide web

DESCRIPTION (provided by applicant): Cigarette smoking remains the number one cause of premature morbidity and mortality in the United States. National data show reductions in smoking prevalence among all age groups except for 18 to 24 year old young adults. Smoking prevalence in this age group is estimated at 24%, and this rate has held steady since 2003. National data indicate that compared to older adults, young adults are less successful at quitting, and they use treatment less often. Even though a sizeable proportion (72%) of young adult smokers are motivated to quit, and 49% have made a serious attempt to quit in the past year, only 4% of young adult smokers who attempted to quit in 2005 reported using behavioral treatment. Randomized trials of cessation treatments that report outcomes by age group show comparable outcomes for young adult and other adult smokers. Thus, quit rates among young adult smokers could improve with increased reach of evidence-based cessation treatments into this population. The underlying premise of the proposed study is that the development of effective strategies aimed to increase demand for evidence-based smoking cessation treatments among young adult smokers will accelerate rates of cessation in this key target population. The proposed study applies innovative research methods to achieve the following specific aims: (1) Implement a multi-phase market test strategy to develop a series of theory-driven internet- based messages to encourage use of behavioral cessation treatments among young adult smokers;(2) Implement a randomized controlled efficacy study to identify a minimum of 4 highly efficacious communications;(3) Implement an interrupted time series (ITS) study to assess the effectiveness and cost effectiveness of the communications under real-world conditions to increase young adult smokers'participation in evidence-based behavioral interventions. The ITS will provide precise detection of the magnitude and duration of trends in the effectiveness of the messages over time in stimulating demand for cessation treatment among young adult smokers;and (4) Conduct a longitudinal cohort study with a sample of young adult treatment participants in order to: (a) Describe patterns and degree of engagement with treatment, and (b) Model factors associated with use of treatment, smoking cessation attempts, and successful smoking cessation. PUBLIC HEALTH RELEVANCE: Interim data indicate little chance of reaching Healthy People 2010 goals with regard to smoking prevalence. Thus, tobacco use is likely to remain the number one cause of premature death and disability into the next generation of young adult smokers. Despite the availability of effective smoking cessation treatments, demand for these treatments remains disappointingly low, particularly among young adults. Little research exists on strategies to enhance demand for evidence-based treatment. The proposed research will help to bridge this gap between the availability and use of effective smoking cessation treatments.

Young adurthood is an important period in the development of regular cigarette smoking and nicofine dependence. Dramafic increases in both the prevalence and intensity of smoking occur after age 18 (Hammond, 2005). Nafional data show that the prevalence of cigarette smoking is higher among young adults (aged 18-24) than among any other age group (CDC, 2007), and there is little evidence of a decline in these rates over the past several years (Johnston et al., 2007). The primary goal of this proposed project is to continue to follow our established cohort of high risk adolescents through the period of young adulthood (approximately ages 19-25 for our cohort), wrth four annual assessments, and to examine the contributions of social and emofional contextual factors to the development of smoking patterns as they emerge from adolescence through young adulthood. We will examine how changes in social contexts (friendship networks, life transifions) may serve as markers for smoking change, and how specific behavioral risk factors (e.g., alcohol and substance use, depression, ADHD symptoms) may confer addifional risk in developing nicofine dependence. In addrtion, we propose to examine, more in-depth, the phenomenon of nicotine dependence across the range of smoking levels, from light and infrequent smokers to more regular and "heavier" smokers, and how nicotine dependence is best assessed and conceptualized at different levels of smoking. This project will take advantage ofthe wealth of rich, longitudinal data already collected on this sample, with a unique opportunity to look specifically at mechanisms that might explain vulnerability to smoking progression and the development of dependence. We will be able to track changes in key variables and smoking from adolescence through young adulthood, and examine how both protective and risk vulnerabilifies present during adolescence and emerging adulthood may play a role in predicfing changes in smoking behavior. Understanding factors that influence the development of smoking patterns (both escalafion and cessation) during the vulnerable period of adolescence to young adulthood is of crifical importance for developing future intervenfions.

Cigarette smoking among adolescents and young adults remains one of the most important public health challenges. Almost all smokers begin smoking while in their adolescent years, but smoking becomes entrenched during the young adult years. Understanding more about the factors that promote or protect against smoking progression and nicotine dependence may help us to develop more effective interventions. Also important is understanding how the transition from adolescence to young adulthood, a transition that brings multiple life changes and heightened risk for behavioral problems, influences smoking patterns that have been set in motion during adolescence. This program project will provide an in-depth, multi-method study of the patterns and predictors of smoking patterns from experimentation onward, from adolescence through young adulthood. This continuation builds on and extends our current work by proposing to continue to follow a high risk cohort of individuals, first identified and characterized during mid-adolescence, and who are now in young adulthood. We propose to follow these individuals through their early twenties, the period of highest risk for establishment of smoking and dependence. We will maintain our focus on the social emotional contexts that may influence smoking, and extend this to explore promising genetic markers for the development of dependence. Across projects, we will also characterize, through multiple methods, the development of dependence from the early stages of smoking onward. The projects are linked conceptually through their common consideration of factors that influence the patterns of smoking from adolescence through young adulthood, and methodologically, through their use of a common cohort of participants. Our overriding interest is in identifying, describing, and predicting patterns of progression of smoking and nicotine dependence, considering the dynamic interplay of genetic, social, and emotional contexts. Our proposed program project comprises four research projects and three cores. The four research projects are: 1) Patterns and Predictors of Smoking from Adolescence to Young Adulthood; 2) Proximal Contexts of Young Adult Smoking Patterns; 3) Emotional Indices of Withdrawal in Young Adult Smokers;and 4) Genetic Risk Markers for Smoking Progression. Our three Cores are: 1) Scientific/Administrative Core; 2) Participant Interaction Core;and 3) Data Management, Measurement, and Statistics Core.

Young adulthood is the developmental period when cigarette smoking becomes more entrenched, with dramatic increases in intensity occurring after age 18 (Hammond, 2005). In order for us to confinue to make gains in reducing rates of cigarette smoking, we need to address the problem of smoking among young adults. This project will use Ecological Momentary Assessments (EMA) to gather real-fime, naturalisfic self reports of young adults'daily experiences and smoking behavior to examine how the immediate situation (proximal context) in which smoking occurs, along with the individual's subjecfive reactions to those experiences, varies by smoking level and influences future smoking behavior. This proposed project builds on several of our compelling findings to date with our current program project. These findings include: a) Mood just prior to smoking differs significantly from random, background times, such that when adolescents smoke, they feel less posifive and more negafive than other fimes. b) Following smoking, adolescents experience a significant relief of negafive affect and boost in posifive affect, c) Importantly, this change in affect predicts smoking trajectory - adolescents who belong to the trajectory with the lowest level of use and who do not escalate in their smoking derived the least amount of posifive affecfive change following smoking;that is, these youth did not experience the "boost" following smoking, d) Mood variability, and not just overall level of mood, may be important in predicfing escalafion. e) Adolescents experience subjective aspects of withdrawal and dependence, even at relafively low levels of smoking. And f) Conjoint alcohol use and smoking may diminish the subjecfive mood boosts from smoking, although social context may be an important moderator. As we follow participants into young adulthood and as their smoking progresses, we will focus specifically on affective prompts and consequences to smoking, tracking of withdrawal symptoms, including new measures of attenfion, craving, as well as safisfacfion with smoking, and the influence of alcohol and social contexts on smoking. This proposed project presents a unique opportunity to track and examine the development of dependence from adolescence through young adulthood. Thus, this project is well posifioned to make a unique contribution to our understanding of the development of smoking patterns and nicotine dependence.

PROJECT SUMMARY (See instructions): The Scientific/Administrative Leadership Core provides the scientific, managerial, and coordinafing structure to ensure the efficient and effective functioning of the program project. The Scientific/Administrative Core includes experienced research administrators, a set of external scientific advisors, and an Executive Steering Committee that provides scientific integrafion, quality control, and oversight across projects and cores. Our specific aims fall under three broad domains: scientific leadership, mentoring, and administration. Our scientific leadership aims include: 1) providing overall scientific leadership to the program project;2) providing an intellectual environment that will generate a collaborafive program of mulfidisciplinary research to address important issues about adolescent and young adult tobacco use, including helping to plan overiapping analyses across projects;3) providing support for and coordinafion of the research activities across projects and cores;4) maintaining policies and procedures forthe program project (e.g., publicafion and presentafion policies, authorship and collaborafive policies);and 5) coordinating and promoting dissemination of research findings. Our mentoring aim includes providing mentoring and career development opportunifies (e.g., peer review publication authorship, national meefing presentations, dissertafion projects) for graduate students, post-doctoral fellows and junior faculty. Our administrative aims include: 1) providing overall administrative leadership and support for the program project;2) maintaining financial oversight of the enfire program project;and 3) coordinating all networking between projects, cores, and Institutions to ensure efficient operations and timely communications, including the maintenance of communicafion vehicles and structures (e.g., password protected web sites for sharing of documents, informafion across projects, cores, and insfitufions). Thus, this core plays an essential role in this program project by serving as the coordinating center of the group of invesfigators and integrating all acfivifies and scientific findings. This type of integration is likely to lead to greater progress in the field.

DESCRIPTION (provided by applicant): Cigarette smoking remains the number one cause of premature morbidity and mortality in the United States. National data show reductions in smoking prevalence among all age groups except for 18 to 24 year old young adults. Smoking prevalence in this age group is estimated at 24%, and this rate has held steady since 2003. National data indicate that compared to older adults, young adults are less successful at quitting, and they use treatment less often. Even though a sizeable proportion (72%) of young adult smokers are motivated to quit, and 49% have made a serious attempt to quit in the past year, only 4% of young adult smokers who attempted to quit in 2005 reported using behavioral treatment. Randomized trials of cessation treatments that report outcomes by age group show comparable outcomes for young adult and other adult smokers. Thus, quit rates among young adult smokers could improve with increased reach of evidence-based cessation treatments into this population. The underlying premise of the proposed study is that the development of effective strategies aimed to increase demand for evidence-based smoking cessation treatments among young adult smokers will accelerate rates of cessation in this key target population. The proposed study applies innovative research methods to achieve the following specific aims: (1) Implement a multi-phase market test strategy to develop a series of theory-driven internet- based messages to encourage use of behavioral cessation treatments among young adult smokers; (2) Implement a randomized controlled efficacy study to identify a minimum of 4 highly efficacious communications; (3) Implement an interrupted time series (ITS) study to assess the effectiveness and cost effectiveness of the communications under real-world conditions to increase young adult smokers' participation in evidence-based behavioral interventions. The ITS will provide precise detection of the magnitude and duration of trends in the effectiveness of the messages over time in stimulating demand for cessation treatment among young adult smokers; and (4) Conduct a longitudinal cohort study with a sample of young adult treatment participants in order to: (a) Describe patterns and degree of engagement with treatment, and (b) Model factors associated with use of treatment, smoking cessation attempts, and successful smoking cessation.

Establishing the University of Illinois at Chicago (UIC) Center for Clinical and Translational Science (CCTS) will fundamentally alter the nature of clinical and translational investigation at UIC and our partners (Advocate Health Care, Jesse Brown VA Medical Center, Ul Peoria, Ul Rockford, Ul Urbana). Harnessing our diversity of background, interests and expertise, the UIC CCTS will effectively catalyze collaborative thinking and innovation. The CCTS will organize, finance, and house the infrastructure, expertise, and resources of value to clinical translational investigators within a single academic home, with leadership that reports to the highest levels of UIC administration. This reorganization crosses administrative boundaries to harness and enhance existing UIC resources. A major element of UlC's vision for its future its operationalized by establishing the UIC CCTS, which will have the following Specific Alms. Specific Aim # 1: Create and develop an academic home for clinical translational research at UIC. This home will provide a flexible and adaptable infrastructure to stimulate collaborative thinking, generative discourse, and collective action to facilitate clinical and translational investigation. The creation of this home will include establishing a robust Pilot Grant Program, a Clinical and Translational Science Academy, a web-based and geographic single-point-of-access for investigators to make use of CCTS expertise and resources, and a CCTS Matchmaking service to identify and catalyze novel collaborations. Specific Aim # 2 contributes to the academic home by establishing the research service infrastructure (the 6 Research Service Cores) to provide clinical research support services required by clinical and translational investigators. Soecific Aim # 3 contributes to creation of the academic home by providing multifaceted educational experiences for pre-and post-doctoral trainees, junior faculty, and established faculty wishing to extend their thinking beyond their current disciplinary boundaries. Establishing the UIC CCTS will optimize collaboration with our key clinical research partners, and allow us to facilitate new and innovative investigation in pediatrics and community-based science. The administrative reorganization represented by the UIC CCTS will lead to rationalization and integration of significant and mature UIC resources for clinical translational research. It will add to these resources to produce something better for clinical translational researchers and trainees at UIC and at key partner institutions.

Cigarette smoking is the leading preventable cause of cancer and accounts for over $96 billion in annual direct medical costs in the US. To reduce the enormous health and economic harms of smoking, we need a comprehensive approach to engage all smokers visiting healthcare settings in treatment that efficiently and effectively helps them stop smoking. Unfortunately, most smokers making a healthcare visit are unwilling to make a serious quit attempt, and there are few empirically validated treatments to motivate them to quit and prepare them to quit successfully. In sum, we do not know which intervention components are optimal for smokers unwilling to quit?a group that comprises the majority of smokers at any point in time. Project 2 aims to identify highly effective intervention components for smokers initially unwilling to quit. Smokers (N=512) making routine healthcare visits to primary care clinics who are unwilling to quit will be identified and recruited using an enhanced Electronic Health Record (EHR). Consistent with the Multiphase Optimization Strategy (MOST), we will use a highly efficient factorial design (2x2x2x2) to test four different intervention components: 1) Type of Nicotine Replacement (Nicotine Gum vs. Nicotine Mini-Lozenge), 2) Behavioral Reduction Counseling (off/on), 3) SRs Motivation Counseling (off/on), and 4) Behavioral Activation Counseling (off/on). These components have strong theoretical and empirical support, but their relative, additive, and interactive effects are unknown. The most promising of these components will be integrated with additional components tested in the other projects in this P01 to form a chronic care treatment that provides effective treatment for all phases of smoking intervention: from motivating quitting to recovering from relapse. Project 2 is linked to other projects in this P01 with a planned interiocking design: as participants express readiness to quit in Project 2, they will receive the Cost-Optimized Cessation treatment in Project 3. Thus, not only will we identify intervention components that produce the greatest smoking reduction and quit attempts, we will also identify which components help smokers benefit from the next element in a chronic care model for smoking treatment.

? DESCRIPTION (Provided by Applicant): Tobacco use behavior is complex and changing, with electronic cigarettes (e-cigarettes) increasing in use. In the face of these changes, we need to know more about the behavioral phenomenon of e-cigarette use and its association with other factors, such as continued combustible tobacco use (conventional cigarettes), nicotine dependence, or changes in patterns of tobacco product use, including reductions or cessation of conventional cigarettes and uptake of e-cigarettes. Understanding e-cigarettes, as they are actually used, will help guide the FDA in their regulatory decisions. This project will use Ecological Momentary Assessments (EMA) to gather real-time reports of dual product (both conventional and e-cigarette) users' daily experiences and tobacco use to examine how the immediate context of tobacco use, along with the individual's subjective reactions to those experiences, varies by product and individual characteristics, and influences future patterns of conventional and e-cigarette use. We address several FDA research priorities: 1) the diversity of tobacco use behavior and associated attitudes, perceptions, and subjective experiences; 2) how subjective experiences associated with the use of diverse tobacco products are associated with tobacco dependence and changes in dependence; and 3) how awareness of e-cigarette messages is associated with expectancies and experiences surrounding e-cigarette use. We will recruit 450 adult cigarette smokers who also use or who are at high risk for using e-cigarettes and conduct two longitudinal waves of EMA. Our aims include: 1) examining the micro-contexts of tobacco use and how they vary by product and individual differences (e.g., demographics, tobacco history, dependence) in order to understand better the functional value of e-cigarettes; 2) examining real-time withdrawal, cravings, and satisfaction with tobacco products and how these affect transitions in tobacco use; and 3) examining how proximal tobacco cues relate to tobacco use experiences, contexts, and patterns of use. Our in-depth examination of the real-time reactions to the use of e-cigarettes directly addresses FDA questions of interest.

The University of Illinois at Chicago (UIC) Center for Clinical and Translational Science (CCTS) seeks to catalyze translational research, locally and nationally, as part of a national network to improve individual and population health. Since our initial funding by the NIH in 2009, the CCTS has been a catalyst for mobilizing institutional support and resources to enhance clinical translational research and expand multidisciplinary training programs to increase workforce diversity and promote team science. The overarching goal?and driving focus?of the CCTS is to improve population health, particularly among minorities and underserved populations. Our high- quality multidisciplinary clinical and translational research, spanning T1-T4 and paired with strengths in community engagement and implementation science and appreciation for the social determinants of health, help to accelerate discoveries into practice and policy. Building on our organizational foundation and record of success, the UIC CCTS is well-positioned to make substantial contributions by collaborating with other hubs, supporting national CTSA activities, and making unique contributions to community-engaged research with vulnerable and underserved populations. As we move forward, we will continue to develop streamlined processes and resources to facilitate research processes and aid collaboration; to develop and prepare a translational science workforce that is multidisciplinary and comfortable in team science; to use innovative informatics solutions to advance translational research; and to have ready-to-deploy systems to respond rapidly to innovative, collaborative projects. We will achieve our objectives through the following global specific aims: 1) Develop a skillful and diverse translational workforce to conduct multidisciplinary team science and advance translation of discoveries; 2) Engage a broad range of stakeholders in clinical translational research, including patients, community leaders, health care providers and clinicians, industry and policy makers; and further support collaboration among the CTSA hubs; 3) Integrate, support, and accelerate clinical translational research across the full translational spectrum with multiple disciplines and with diverse populations across the lifespan; 4) Promote advances in study and development of methods and processes of conducting translational science that will enable advances in translation; and 5) Support the use and advance of innovative informatics solutions to advance translational research and to help train the CTSA workforce. These aims will direct our course over the next five years, as we further evolve the clinical and translational enterprise, contribute to the CTSA network, and advance the health of the people of Illinois and the nation.

Combustible tobacco use remains the primary cause of cancer morbidity and mortality in the United States, and a major cause of cardiovascular and pulmonary diseases. Although there has been tremendous progress in reducing cigarette smoking, approximately 15% of adults over age 18 in the U.S. currently smoke cigarettes, and progress with smoking cessation may be stalling. To reduce the substantial toll from tobacco, we need to consider a variety of approaches to more rapidly reduce its harm, especially for those smokers who may not be motivated or ready to stop smoking or who have been unsuccessful in quitting with current cessation treatments. The primary purpose of this study is to examine whether conventional, combustible cigarette smokers can reduce their use of cigarettes and associated harms by switching to an e-cigarette (Standardized Research E-Cigarette or SREC). This project will use Ecological Momentary Assessments (EMA) to gather real-time, naturalistic reports of conventional smokers' use and experience of SREC as they attempt to switch from combustible cigarettes to SREC. We will examine how the proximal contexts and subjective experiences surrounding SREC use differ from smokers' patterns and responses to conventional cigarette use, and how these patterns of differences may predict success in switching. In addition, we will assess in-depth, in real time, smokers' reports of urges and withdrawal symptoms as they switch to SREC. We will also evaluate changes in health and biomarker variables. We will enroll a sample of 180 adult combustible cigarette smokers who are interested in switching to e-cigarettes. Participants will complete a baseline one-week EMA wave while they are smoking their usual cigarettes, complete baseline assessments, and then will be randomized (within sex and use of menthol cigarettes) in a 2:1 ratio to either a nicotine SREC or a placebo SREC. Participants will receive brief behavioral counseling about switching, and after an initial week of using SREC, they will complete another EMA week assessing patterns and responses to use of both SREC and cigarettes. Participants will receive 12 weeks of SREC; compete daily reports of product use along with bi-weekly check-ins through the end of the 12-week trial, and then complete a one-month follow-up. Our aims are to: 1) Examine whether conventional cigarette smokers can significantly reduce their combustible cigarette use by switching to SREC; 2) Examine whether reductions in conventional cigarette use and uptake of SREC are associated with changes in health and biomarker variables; 3) Examine smokers' subjective responses to SREC in real time, as they are used, and whether these responses are associated with cigarette reduction; and 4) Examine how patterns of use (e.g., contexts, timing) and subjective experience with SREC differ from conventional cigarette use, and whether differences are associated with success in switching to SREC. Data from this study will provide valuable information about the potential for harm reduction if smokers switch to SREC.

Project Summary Healthcare systems have tremendous potential to deliver evidence-based smoking cessation treatment to the roughly 25 million US smokers who receive primary care each year, but dissemination of smoking cessation treatment innovations has been slow and implementation of best-practices poses major challenges. For treatment advances to have a substantial impact on smoking prevalence and smoking-related morbidity and mortality, the reach of cessation treatments must increase; too few patients who smoke are offered quitting assistance, and only 5% of US smokers trying to quit use both counseling and pharmacotherapy, the recommended cessation treatment. This project seeks to generate a deeper understanding of factors associated with the reach and implementation of a comprehensive program (the Comprehensive Chronic Care for Smoking Program, CCCSTOP) for adult primary care patients who smoke that is being evaluated in this Program Project. The program is designed to motivate quitting (in those not initially willing to quit) and to help those ready to quit achieve abstinence. The key components of CCCSTOP are: systematic assessment of smoking status at primary care visits; automatic referral of patients who smoke to a centralized care manager who delivers proactive smoking interventions (unless patients opt out); coordination of pharmacotherapy and counseling with primary care providers and the state quitline; and screening and referring medically eligible patients who want help quitting to centralized intensive pharmacotherapy and counseling services. The current project will examine the reach and implementation of key facets of the program using assessments guided by the RE-AIM planning and evaluation framework and the PRISM approach to assessing intervention-translation context. Multilevel, multimethod data will be collected to address the following aims: 1) to evaluate the reach, representativeness of reach, and maintenance of reach across time in the 16 clinics that will host the project in 2 healthcare systems; 2) to evaluate intervention fidelity, adaptations, maintenance, correlates, and outcomes across patient groups, personnel, roles, and sites; and 3) to examine the extent to which implementation is associated with the key outcome of public health interest in this project: abstinence from smoking. Data to support these aims will be collected from electronic health records of patient smoking and smoking-related intervention exposure; patient ratings of satisfaction; front-line clinic staff and clinician surveys, interviews, observation, and performance metrics; in-depth interviews with and direct observation of care managers who will engage smokers and deliver interventions; and semi-structured interviews with clinic- and system-level leaders who influence adoption and implementation decisions. This project will cut across ecological levels (patient to system) using mixed methods in 2 separate implementation cohorts. This will advance our understanding of challenges in implementing systematic, sustained efforts to expand the reach and effectiveness of smoking cessation treatment, and thereby reduce morbidity and mortality related to smoking.

Co-use of tobacco and cannabis has been increasing, especially among young adults in the US, with more than 20% of young adults aged 18-24 reporting use of both substances in the past month. There is growing evidence that co-use of these substances increases the health consequences and problematic psychosocial outcomes of either alone, and that use of one product increases the probability of use and failure to stop the other. Co-use is a broad term and may encompass using both substances within a given time frame (e.g., past month), within a given episode (concurrent use), in sequence (chasing), or mixed together in the same delivery device (co- administration). Until recently, co-use was also generally limited to combustible methods, either smoking each product separately or combining them (e.g., in blunts or spliffs). With the increase in electronic nicotine delivery systems (ENDS) as well as the increase in states legalizing recreational cannabis, there are new options for co- use, and ENDS devices that vape e-liquids containing nicotine are becoming more popular methods to consume cannabis. Although research on co-use is growing, there have been numerous methodological limitations of prior work, including a lack of detailed data about differences in specific patterns of co-use and modes of delivery, especially given the rising popularity of alternative tobacco products, as well as a reliance on survey data. Less is known about the factors that may contribute to the different patterns of co-use in young adults, that may maintain co-use, and that may be associated with different outcomes. The overall goal of this study is to examine the situational, momentary factors associated with the different patterns of tobacco and cannabis co-use, how they may vary by delivery mode, and how they are associated with changes in behavioral outcomes (e.g., dependence, changes in rates of use, problem behaviors). This project will use ecological momentary assessment (EMA) to gather in-depth, real-time naturalistic reports of 425 young adult (aged 18-25) tobacco and cannabis co-users? daily experiences and product use behaviors. Across two waves of EMA, we will capture episodes in which young adults use each product alone as well as when they use them concurrently (during the same episode), either in a common delivery device (e.g., blunt or vaporizer) or in succession. We will examine how the proximal context in which the combination of product use occurs and the individual's subjective, affective, and neurocognitive reactions to those use experiences vary by delivery mode (combustible or vaporized) and individual characteristics, and how these factors influence future tobacco and cannabis use patterns. Knowledge gained will provide needed evidence about the behavioral and neurocognitive consequences of co-use use that will help better inform prevention, intervention, and policy approaches to reducing harms of both products. This project is also timely in that its data collection occurs in a state (Illinois) that will have just legalized recreational cannabis use (effective January, 2020).

Abstract Advancing clinical translational research requires a highly competent and well-qualified workforce of investigators and other team members who can effectively and efficiently conduct critical research. One frequent barrier to the rapid and rigorous implementation of research is inefficiencies or inconsistencies in executing needed regulatory or administrative start-up processes and in maintaining high quality assurance and control processes throughout all stages of the research process. This proposed supplement addresses this gap in the research enterprise by creating a Research Navigation position and process for the University of Illinois Center for Clinical and Translational Science (UIC CCTS) that will help to streamline and standardize oversight, processes, and training needed to ensure that all administrative and research-related material submissions to NCATS on behalf of the CCTS are of the highest quality. These process improvements will help strengthen the capacity of the UIC CCTS to rapidly implement time-sensitive and other urgent research projects, improve the overall quality of work, and help fulfill one of our primary parent grant aims of improving methods and processes related to clinical and translational research. Our expectation is that successful implementation of this proposed supplement will result in more rigorously conducted (i.e., fewer reported errors and more rapid turnaround) research and reduce redundant requests and research delays, thereby accelerating the pace of advancing the translation of new research knowledge into improving health outcomes.

Project Summary/Abstract The University of Illinois at Chicago (UIC) Center for Clinical and Translational Science (CCTS) seeks to catalyze translational research, locally and nationally, as part of a national network to improve individual and population health. Since our initial funding by the NIH in 2009, the overarching goal?and driving focus?of the CCTS is to improve population health, particularly among minorities and underserved populations. Our high-quality multidisciplinary clinical and translational research, spans the translational spectrum and includes strengths in community stakeholder engagement. Building on our organizational foundation and record of success, the UIC CCTS is well-positioned to make substantial contributions by collaborating with other hubs, supporting national CTSA activities, and making unique contributions to community-engaged research with vulnerable and underserved populations. Across academic research institutions, community and patient stakeholder engagement is now increasingly incorporated into individual research projects, yet it is not typically a part of ethical and regulatory oversight of research. This may lead to under- or over-protection of research participants. Increased collaboration between human research protections programs (HRPPs) and institution-level community engagement activities could bring stakeholder perspectives to bear on research ethics oversight, but there is much to learn about how relationships could be strengthened and efforts better coordinated to enhance human research protections. This proposed bioethics supplement to UIC?s Center for Clinical and Translational Science responds to NIH?s call for bioethics research to develop an evidence base that may inform future policy directions, focusing on patient/participant representation in research oversight and study design. The goals of this project are to identify, prioritize, and disseminate strategies and resources for increasing stakeholder engagement in research ethics oversight with a focus on strengthening relationships between human research protections programs (HRPPs) and institutional community engagement activities. The specific aims are to: 1) Generate a menu of strategies that HRPPs could implement to increase the inclusion of stakeholder perspectives in research ethics oversight; and 2) Foster consensus regarding priority strategies for HRPPs to increase appropriate inclusion of stakeholder perspectives in research ethics oversight.