Thomas Babor - US grants

The WHO Alcohol Misure Early Treatment Intervention Study (AMETHYST PROJECT) is a multinational field trial of low cost intervention strategies suitable for use with early problem drinkers in the primary health care setting. This application describes the role of the University of Connecticut Alcohol Research Center in a collaborative study to be coordinated by the WHO Division of Mental Health and conducted independently in Wales, Costa Rica, Australia, Norway, Mexico, Kenya, Bulgaria and the United States. The specific aims of the project are (1) to study the relative contributions of simple advice, brief counseling and periodic monitoring to changes in drinking behavior six months and one year after the initial intervention, (2) to investigate the mediating role of reduced consumption on the incidence of alcohol-related problems, and (3) to evaluate the robustness and cross-national generalizability of early intervention strategies at hospital-based performance sites in two countries. In the U.S. and Mexican components (for which funds are requested in this application), 240 non-alcoholic, nondependent drinkers considered to be consuming alcohol in a potentially harmful way will be randomly assigned to one of six conditions representing three levels of intervention (control, simple advice, brief counseling) and two levels of monitoring (no monitoring, periodic monitoring). The simple advice condition will consist of firm encouragement to reduce the quantity and frequency of alcohol consumption to less than 40g ethanol per day. The brief counseling session will consist of information feedback, individual goal setting, and a review of behavioral change strategies. The latter will be guided by a self-help manual which the subject will be encouraged to use with the assistance of a spouse, family member or close friend. periodic monitoring will consist of return visits to the counselor who will review the subject's drinking behavior, provide simple advice, and take a blood sample. Outcome measures including quantity and frequency of drinking, changes in social adjustment and alcohol related problems, and variations in biochemical measures (MCV, GGTP) will be assessed six months and one year after the initial intervention.

The purpose of this five year project is to coordinate a multi-site clinical trial of patient-treatment matching at five to nine designated collaborating centers, referred to as Clinical Research Units (CRUs). The long term objectives are to test hypotheses derived from treatment research and alcoholism theory that suggest that treatment efficacy can be improved significantly by matching patients to appropriate types of therapeutic interventions. The specific aims of the Coordinating Center are to plan, organize and implement a common research protocol at the collaborating CRUs during three stages of the project. During the initial or planning stage of the project, the Coordinating Center will facilitate the work of the Steering Committee (to be composed of CRU Directors, NIAAA Staff, and outside consultants) as the final plans for the research design and project objectives are decided. This application proposes a coordinating procedure that will facilitate the development of consensus with respect to the most appropriate research design and study implementation plan. In the second stage of the project, all centers will pilot test the common protocol after receiving initial training from the coordinating center. A major aim of this stage is to develop procedures to ensure the specificity, distinctiveness and consistency of study treatments across sites by developing training manuals for each treatment, conducting standard training programs for therapists from all sites, and devising process rating techniques to monitor therapist skill, relationship quality, and proper implementation of study therapies. In the third phase of the project, the coordinating center will monitor implementation of the study; develop standard procedures for recording, entry, editing, and management of data from the CRUS; conduct multivariate statistical analyses; and assist the Steering Committee in the preparation of reports and scientific publications.

This proposal describes the purpose and organizational plan for a scholarly symposium that will explore recent research and current theory pertaining to alcoholic typologies, giving special emphasis to genetic susceptibility and biological markers of clinical subtypes. It proposes that recent developments in research and theory on alcoholics subtypes makes a conference on this topic particularly timely, especially in light of recent trends in such related areas as genetic epidemiology, treatment matching, and biological markers for alcoholism. By bringing together a diverse group of clinical, epidemiological and experimental researchers, the conference will provide opportunities for presenting new research findings, exploring commonalities across diverse theoretical and methodological approaches, and considering implications for diagnosis and treatment.

The purpose of this three-year Coordinating Center (CC) application is to continue the coordination of Project MATCH, a multi-site clinical trial of patient-treatment matching at nine designated collaborating centers (Clinical Research Units or CRUs). The long-term objectives of the trial are to test hypotheses derived from treatment research and alcoholism theory that suggest that treatment efficacy Can be improved significantly by matching alcoholics to appropriate therapeutic interventions. The project consists of two independent treatment matching studies, which are designed to evaluate the interaction between selected patient characteristics and three treatment modalities: l) a Twelve-Step approach, designed to facilitate affiliation with Alcoholics Anonymous; 2) Cognitive-Behavioral therapy derived from social learning principles; and 3) a Motivational Enhancement approach that aims to mobilize the patient's own resources in the service of recovery. The trial is nearing the end of its first five years of funding, having successfully completed three of its four stages (planning, pilot testing, and implementation). Although preliminary data analyses will be completed by the end of the fifth project year, the work proposed in this application allows for an extension of the fourth and final stage, which will be devoted to data analyses, the reporting of findings, and the collection of long-term follow-up data. To achieve these objectives, the CC will perform the following tasks: A) Project Coordination. In addition to the coordination of trial-wide data analytic efforts, the CC will continue to exercise "executive secretariat" functions (e.g. communications, meetings) that facilitate the work of the Steering Committee. B) Data Management. This aim involves data cleaning and preparation of codebooks and documentation; distribution of trial datasets for analysis by individual investigators and working groups; and maintenance of study archives. C) Data Analysis. A third aim of the CC is to conduct trial-wide analyses of ten a priori primary matching hypotheses In accordance with the data analysis plan approved by the Steering Committee. In addition, the CC has major responsibility for the analyses of treatment process data, which are necessary for studying the "casual chains" associated with individual matching hypotheses. D) Investigator-Initiated Activities. During the continuation period, CC investigators will have responsibility for two of the trial's primary matching hypotheses (gender and typology), will implement a highly sophisticated analysis of treatment processes, and complete work on an innovative study of interviewer reliability. E) Information Dissemination. This aim concerns the CC's role in reporting to the Data Monitoring Board, the NIAAA, and the scientific community. As specified in the Steering Committee's publication plan, CC Investigators will prepare research reports on gender, typology, and treatment process, and will edit a book that summarizes the trial's major accomplishments.

This project builds upon an ongoing investigation funded by a private foundation. Research data pertaining to the efficacy and cost of treatment services for alcohol-and-drug-involved adolescents have been collected as part of a process evaluation of Youth Evaluation Services, an assessment and case management program operating in Connecticut's greater Bridgeport area. Funds are requested to analyze the existing database. In combination with the results of a comprehensive diagnostic baseline evaluation, parent interviews, and record reviews, data collected from 300 adolescents at program intake and a follow-up will be used to address four specific aims: 1. To assess the effects of treatment setting and intensity on client outcomes six months following intake assessment. Of particular interest will be comparisons between clients receiving inpatient, outpatient, or no conventional treatment, statistically controlling for intake severity and other client characteristics related to outcome. 2. To determine the predictors of treatment outcomes, service utilization, and service costs. The predictive utility of demographic characteristics, type of insurance coverage, problem severity, and concomitant psychosocial problems will be explored using logistic and linear multiple regression techniques. 3. To examine the effects of case management of service utilization, cost, and outcomes. Case management coordinates services, monitors client recovery, and attempts to contain treatment costs. The proposed study will examine the effects of case management activities on treatment utilization, efficacy, and costs.

This component consists of two separate studies that deal with alcohol dependence as a psychobiological process. The first study (cue reactivity) is the continuation of an ongoing project designed to evaluate the effect of cue exposure treatment on urges to drink and relapse in abstinent alcoholics. Seventy inpatient alcoholics are being randomly assigned to six sessions of individual therapy involving either alcohol cue exposure plus coping skills training or coping skills alone. Changes in reactivity to alcohol-related cues are assessed in the laboratory. Follow-up interviews are conducted to assess treatment outcome at 3 and 6 months after discharge from inpatient treatment. Subjects repeatedly exposed to alcohol cues are expected to show a decrease in cue reactivity and be less likely to relapse. After this research is completed in the second grant year, a different group of investigators will initiate a three-year study of vulnerability factors that may contribute to the development of alcohol dependence through the mechanism of stress dampening. Eighty moderate to heavy drinkers (40 males, 40 females), half with a history of familial alcoholism, will be studied in the natural environment using an intensive daily process methodology during a 50-day observational period. The study will examine family history of alcoholism (FH+), gender, and affective reactions to daily events as predictors of alcohol use. It is hypothesized that FH+ individuals compared to FH- individuals will be more extreme in their affective reactions to negative events; exhibit greater dampening of these responses when alcohol is consumed prior to a stressful event; and report more alcohol use after experiencing such events. These hypotheses, if confirmed, will provide valuable evidence for a theoretical model that implicates the interaction between genetic vulnerability and psychological reinforcement as basic mechanisms in the development of alcohol dependence.

Project MATCH was a multisite clinical trial (Cooperative Agreement) that produced a rich data set on patient treatment amtching in alcoholism treatment.The objective of this contract is to support the preparation and refinement of the data collected in Project MATCH for distribution to the scientific community. Establishment of a user- friendly data tape and associated documentation, and the maintenance of a public website interface with users is required.

DESCRIPTION (provided by applicant): The long-term goals of this research are to develop both methodological tools and empirical findings that will advance knowledge about the public health impact of malt liquor advertisements. The project is particularly concerned with methods to evaluate industry self-regulation codes that are used to guide the marketing and content of both TV and print advertisements for these products. During the formative stage of this project, and archive of TV and print ads will be compiled, focus groups will be conducted to develop operational measures of industry guidelines, and reliability of these measures will be evaluated in a test-retest study with 75 participants selected in the basis if age (18-24), gender, and ethnic diversity. Once the measures have been developed, they will be used in a laboratory-based study of representative TV and print ads with a sample of 480 participants recruited from both inner city neighborhoods and college campuses. The research is designed to answer the following questions: Are models portrayed in malt liquor ads perceived to be in conformance with industry guidelines pertaining to age, responsible drinking behavior, attractiveness and other recommended standards? Do the evaluations of models portrayed in TV commercials and print ads vary as a function of the viewer's structural (e.g., age, gender, ethnic group membership) and individual difference (e.g., drinking history, alcohol expectancies, personality traits, family history of alcoholism) vulnerability factors? Are TV commercials more of less in compliance with industry codes than print ads, and do viewer perceptions of TV print ads differ according to the putative structural and individual difference vulnerability factors? The significance of the research described in this application lies with its potential to advance the methodology necessary to evaluate the adherence of malt liquor ads to industry self-regulation guidelines, and to provide preliminary empirical data about both conformance and these guidelines and vulnerability factors that are associated with nonconforming perceptions by vulnerable viewers.

DESCRIPTION (provided by applicant): This proposal describes a 3-year study that will investigate the effectiveness of a Brief Intervention (BI) for high risk (non-dependent) use of illicit drugs as linked to the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST), a new instrument developed by the World Health Organization (WHO). The ASSIST was recently developed by an international group of researchers to screen for problem or risky use of tobacco, alcohol, cannabis, cocaine, amphetamines, sedatives, hallucinogens, inhalants, opiates and other drugs. The proposed study will allow US participation in an international multi-site collaborative project to evaluate the effectiveness of a brief intervention for four illicit drugs (cannabis, amphetamines, cocaine and opiates) as linked to the WHO ASSIST. The study will use a randomized controlled design in which eligible patients (N=160 non-dependent users of four illicit substances) presenting for care at a large dental clinic will be randomly assigned to either an experimental condition or a waitlist control group. Experimental subjects will receive a brief motivational intervention for the drug with the highest ASSIST severity score as well as self-help materials relating to that drug. Both groups will be re-assessed at three and six months with the ASSIST and related outcome measures. The project will be conducted independently at the University of Connecticut but will be linked to a larger multi-site study being sponsored by WHO at collaborating international sites where an additional 740 participants will be recruited.

[unreadable] DESCRIPTION (provided by applicant): [unreadable] [unreadable] The six-year period between 18 and 24 years of age is critical in terms of the development of addictive behaviors. Marijuana use is particularly prevalent among young adults who smoke cigarettes, and there is reason to believe that the two behaviors should be approached concomitantly. This protocol describes a 4-year study that will investigate the effectiveness of two types of Brief Intervention (BI) for tobacco and marijuana use as linked to the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST), a new screening test developed by the World Health Organization. Following initial exposure to smoking cessation therapy, 300 young adult cigarette smokers who are also marijuana users will be randomized to three conditions: 1) a wait list control group; 2) a group receiving one session of brief intervention for their marijuana use; and 3) a group receiving the same one session of MET along with a referral to an additional two sessions of brief therapy. Participants will be reinterviewed at 2, 4 and 6 months post randomization. The specific aims of the study are to answer the following questions: 1) Does exposure to smoking cessation therapy reduce marijuana smoking? 2) Does a marijuana-specific BI reduce marijuana use following smoking cessation therapy? 3) Does the more intensive three-session intervention reduce marijuana use more than one session? And 4) Are these interventions equally effective across groups defined by gender and ethnicity? The long-term objectives of the study are to develop screening and brief intervention procedures that will be feasible and effective in primary health care settings for the young adult population. [unreadable] [unreadable]

DESCRIPTION (provided by applicant): Alcohol screening and brief intervention (SBI) procedures have been evaluated in the context of clinical research programs over the past two decades. In the developed countries of Europe, Australia, and North America, SBI efforts have progressed to the point of practical demonstrations and some system-wide applications. But alcohol SBI has seen little implementation in developing countries. The World Health Organization (WHO) is now undertaking a project on the Implementation of Brief Interventions in Primary Care Settings, which will involve program implementation (but no evaluation) within large population areas in Brazil and South Africa. The University of Connecticut Health Center (UCHC) is therefore proposing an international study to evaluate the WHO SBI implementation project. The proposed evaluation has two specific aims. First, the study will evaluate the effects of SBI implementation at the level of health care workers, measuring changes in knowledge, attitudes, and the practice of screening and providing brief interventions. Second, the study will assess the success of the SBI implementation projects in engaging and employing community partners in an alliance that results in the adoption and implementation of SBI by the regional and national health system as a standard of care. The results of this evaluation, when combined with the findings of prior research in developed countries, will provide a foundation for a comprehensive, international approaches for planning, monitoring, and evaluating SBI implementation.

[unreadable] DESCRIPTION (provided by applicant): As part an R21 exploratory and developmental research project supported by NIAAA, we have been developing procedures that can be used by public health professionals and government officials to monitor the content of alcohol advertising on television and in other media. In this R01 application, we propose to conduct two inter-related studies to validate a new rating procedure designed to detect code violations in industry guidelines for responsible advertising. Study 1 will examine the validity of Delphi technique as an enhanced method to evaluate advertising code violations. The Delphi technique consists of a series of sequential questionnaires or 'rounds', interspersed by controlled feedback, that attempts to obtain the most reliable consensus of opinion from a group of experts or important constituency groups. The research will use a two group repeated measures cross-over design that compares the guideline ratings of a "vulnerability group" and an "expert group" at Time 1 (initial rating) and Time 2 (feedback-assisted rating). The Vulnerability group will consist of 150 research volunteers selected to represent the vulnerability characteristics (e.g., women of childbearing age, underage drinkers, minority ethnic group status) the industry codes were designed to protect. The Expert group will consist of 150 research volunteers selected on the basis of their expertise in five areas (e.g., public health, psychiatry) considered to be highly relevant to the evaluation of industry advertising guidelines from a public health perspective. Following completion of the first round ratings, participants will be randomized to receive feedback either from their own group or from the other group. Study 2 will build on the findings of Study 1 in order to conduct the first systematic evaluation of a nationally representative series of alcohol advertisements. The research will apply the Delphi technique to the ratings of up to 45 TV advertisements that have been broadcast in national markets likely to be viewed by large numbers of young adults and other vulnerable populations. The long-term goals of this research are to develop both methodological tools and empirical findings that will protect vulnerable populations and enhance the ability of regulatory agencies to monitor alcoholic beverage advertising. [unreadable] [unreadable]

Component VI - Translational, Dissemination and Educational Activities Related to Alcohol Research This component describes a program of translational, dissemination and educational activities that are integrated with the Center's theme, investigators, and research programs. We propose to consolidate and expand activities initiated within the UCONN ARC in past years to provide greater service to the research community, clinical practitioners, and health service administrators at the state and national levels. The following activities will be conducted over a five-year period: 1) Further development of research integrity and professional development activities. In collaboration with the International Society of Addiction Journal Editors; (ISAJE), we will develop an on-line tutorial based on the book, Publishing Addiction Science (Babor et al., 2004). This will build on an existing foundation and will provide a distance learning capacity to teach graduate students, postdoctoral fellows and junior faculty the essential elements of publication practices and publication ethics. 2) Dissemination of alcohol screening and brief intervention technologies at the state and national levels. These activities will be conducted in collaboration with the State of Connecticut and the federal Center for Substance Abuse Treatment, and will include the development of a continuing education workshop, consultation with state agencies, and collaboration with key experts to coordinate dissemination activities through training workshops and strategic planning programs. There has been growing attention to brief interventions, but their dissemination and continued development in practice requires ongoing work. 3) Organizing a consensus conference on the ethical challenges of conducting research on the genetics of alcoholism and disseminating findings to the alcohol research community. The training and dissemination activities described in this component have the potential to facilitate the translation of research into practice and to improve ethical awareness and publication capabilities in the alcohol research community.

DESCRIPTION (provided by applicant): (Abstract) "Comparative Effectiveness and Feasibility of SBIRT in a General Dental Clinic" addresses the broad Challenge Area, (05) Comparative Effectiveness Research and specific Challenge Topic, 05-DE-102: Treatment of tobacco and drug dependence in dental settings. This protocol describes a 2-year, randomized controlled trial designed to achieve two primary aims: 1) to evaluate the short-term effectiveness of screening, brief intervention and referral services (SBIRT) for tobacco and other psychoactive substance use when delivered separately and in combined forms and 2) to evaluate the feasibility of implementing SBIRT for patients with at-risk substance use in a community general dental setting. This research will provide the basis for a more ambitious clinical trial that would be conducted in multiple dental settings and include a longer follow-up period. To achieve Aim 1, 175 patients who are smokers and at-risk substance users (including at-risk alcohol users) will be recruited from the general dentistry clinic at the University of Connecticut Health Center. Research staff will use the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST), developed by the World Health Organization, to identify eligible patients. Participants will be randomized to one of three experimental conditions: 1) a smoking-only brief intervention group;2) a smoking + other substance use brief intervention group;or 3) a wait-list control condition that includes general dental health counseling. Those assigned to the "active" treatment conditions will be given a brief intervention that will link the patient's screening assessment data with dental risk factors associated with tobacco only or tobacco + other substance use. Participants will be re- interviewed at 12-weeks post randomization to assess outcome and process measures using a combination of quantitative and qualitative interviewing methods. Regarding Aim 2, the timing of this opportunity and implementation of this clinical trial provides a unique opportunity to follow two cohorts of dental residents to examine the impact of SBIRT residency training on subsequent clinical practice. The first cohort will already be on staff when the study begins and will not have received SBIRT training as part of the residency requirements. The second cohort of residents will be exposed to a three-hour SBIRT training session that will supplement the residency requirements for July, 2010. Although residents will not be asked to provide the brief interventions for the randomized study, they will be encouraged to reinforce the information delivered by research staff. Differences between the two cohorts with regard to attitudes, knowledge and willingness to engage in SBIRT program activities will be measured. There has been a remarkable growth in translational research organized around the SBIRT concept, with numerous clinical trials conducted, new screening tests developed, and implementation programs evaluated to determine the feasibility of SBIRT in primary care and other medical settings. Despite the obvious relevance of SBIRT to the prevention of dental pathology, there has been little attention to the determination of its feasibility, effectiveness and implementation in dental settings. We believe there is now a real research opportunity to not only evaluate the effectiveness of SBIRT with dental patients, but also to improve the technology so that oral health practitioners can feel confident conducting screening, brief intervention and referrals for at-risk users of tobacco, alcohol and other substances. The research described in this application could have significant implications on both clinical science and public health dentistry.

This component describes research translation and information dissemination activities that are designed to provide greater service to the research community, clinical practitioners, policymakers, and health service administrators at the state and national levels. Working in collaboration with international programs like the Worid Health Organization (WHO) the Pan American Health Organization (PAHO), and the EU/USA Transatlantic Dialogue on Underage Drinking, we propose to conduct the following activities over a five-year period: 1) Dissemination of alcohol screening, brief inten/ention and referral to treatment (SBIRT) technologies at the state and national levels. These activities will be conducted in collaboration with the WHO, PAHO and the federal Center for Substance Abuse Treatment, and will include the dissemination of a new SBIRT training package in English and Spanish. 2) Dissemination of evidence-based alcohol policies to address underage drinking. This subcomponent will use the resources developed by an international consortium of alcohol experts (the EU-USA Transatlantic Dialogue) to develop a Users Manual and training workshop for alcohol researchers and other professionals interested in translating research into practice at the state and national levels. 3) Dissemination of guidelines on the ethical challenges associated with research and research translation related to the genetics of alcoholism. The guidelines were recently developed by the UCONN ARC and will now be disseminated to the alcohol research community in both workshop and on-line formats designed to improve ethical awareness of alcohol researchers.

? DESCRIPTION (provided by applicant): This application requests funding for the development of an International Certificate in ATOD Research on Addiction (ICARA) for graduate students and post-doctoral fellows in the health professions. It describes an innovative sequence of courses designed to promote basic, clinical, and epidemiological and policy research on alcohol and other substances by a wide array of health professionals, both individuals currently practicing their professions and those in training for health professions. The proposed activities include the development of five graduate-level courses and specific curricula around the theme of alcohol and addiction studies, as well as related materials designed to educate scientists, educators, service providers, and others about how to conduct scientific research on alcohol and other drug use disorders. The ICARA program will accomplish the following aims: 1) enlist members of the target health professions audience as consultants in the planning process; 2) develop educational innovations and materials in both traditional and online formats; 3) evaluate meaningful outcomes; and 4) market the program to educational institutions serving the target professions and 5) share products with NIAAA and international organizations for use through websites, workshops, trainings, conferences, and presentations.