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SUMMARY Problems with alcohol continue to exact a great toll on individuals and societies. In the United States, alcohol use is involved in nearly 100,000 deaths annually and plays a major role in numerous medical and social problems. The National Institute on Alcohol Abuse and Alcoholism (NtAAA), which was given responsibility by Congress for fostering research on the prevention and treatment of alcoholism, asked the Institute of Medicine (IOM) to undertake a study to assess the current state of knowledge about alcohol-related problems and to identity the most important and promising avenues for research into (a) their causes and consequences, (b) their prevention, and (c) the treatment of those who suffer the ill effects of alcohol misuse. IOM completed the first phase of this study in 1987, releasing a committee report entitled Causes and Consequences of Alcohol Problems: An Agenda for Research. The present report, which deals with research in the prevention and treatment of alcohol-related problems, represents the second and final phase of that effort. The report is divided into three parts. In the first part, the committee examines the social and personal aspects of alcohol-related problems toward which prevention efforts are directed; delineates the features of a public health orientation that it deems most appropriate for the prevention task; discusses individual vulnerability to alcohol misuse; reviews genetic, developmental, and social learning perspectives on prevention; and indicates how various perspectives both differ from and complement each other. Also examined are relevant initiatives that have been undertaken at the community level in other health-related fields. The committee concludes by making recommendations for promising research opportunities that should be pursued. In Part II, which is devoted to treatment research, the committee begins its discussion with a brief historical introduction and then presents a review of recent research and future research opportunities. In doing so, it considers the underlying philosophical issues as well as the formidable methodological problems in conducting treatment research. Central to this is a broad review of available treatment modalities and the methodological difficulties involved in developing effective patient-treatment matching schemes. Noting the similarities between alcohol and other substance abuse disorders, the committee reviews advances in research on smoking cessation and dependence on other drugs. Part II also presents an overview of recent studies on the treatment of various medical sequelae of alcohol abuse, concluding with a discussion of research on cost considerations and related issues that are important to the formulation of public policy for the provision of alcohol treatment services. The committee identifies research opportunities in each area explored. In the final part of the report, the committee concludes that cooperative multisite research efforts are indispensable to the implementation of the research directions it recommends. It also offers recommendations to NIAAA concerning the kinds of funding mechanisms deemed most suitable for achieving the agency's goals. Throughout their deliberations, committee members clearly expressed the view that alcohol problems constitute a continuum that ranges from occasional misuse by social drinkers to chronic misuse by individuals suffering from alcohol dependence syndrome. This report considers numerous points along that continuum. The prevention part of the report, with -1

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its strong orientation toward primely prevention (i.e., preventing the onset of problems), emphasizes the environmental influences that can interact with genetic, constitutional, and biological vulnerabilities of the individual and eventually result in a variety of harmful behaviors. Prevention research thus includes social, legal, and community-wide interventions that might alter the behavior not only of individuals but of entire societies. Treatment research is concerned with individuals who are at a point on the continuum at which they can be identified as having an actual alcohol problem. RESEARCH OPPORTUNITIES IN THE PREVENTION OF ALCOHOL PROBLEMS A PUBLIC HEALTH PERSPECTIVE The wide distribution of alcohol problems in the population has strong implications for the direction prevention research should take. Until recently, the prevailing model emphasized prevention of the extreme problem of alcoholism or alcohol dependence. Now, however, that focus has expanded to a broader interest in alcohol-related problems, a concept that encompasses a far greater range of individuals and necessarily expands the range of prevention activities to include not only drinking behavior but also the medical, personal, and social consequences of alcohol use. As a conceptual framework for organizing its discussion of current prevention research and future research opportunities, the committee found a public health perspective to be particularly useful. The public health model posits three elements that interact to produce or attenuate specific problems. These elements are the agent (alcoholic beverages); the individual, or "host," who has the problem; and the environment (the physical, interpersonal, and social milieu surrounding the use of alcohol). The strength of the public health model is that it highlights the interactive nature of these elements in alcohol problems and illuminates the complexity that is now known to exist. Interventions based on such a view can thus take into account more of the possible factors or variables that are involved not only in the causation of problems but in their prevention. Preventive interventions generally can be seen as attempts either to alter an agent, individual, or environmental factor that contributes to an alcohol problem or, conversely, to exploit a factor that reduces risk. Interventions can be universal (directed at an entire popudation), selected (directed at a subgroup considered to be at greater risk than others for a problem), or indicated (directed at specific individuals who actually show signs of possible problems with alcohol). The committee's use of the term prevention in Part I is limited largely to the prevention of the onset of problems; indicated interventions would be considered secondary prevention or early therapeutic intervention and are discussed in the treatment section of the report (Part II). The committee uses this framework in its discussions of a number of aspects of alcohol problem prevention: the epidemiology of alcohol problems; the interactions among the elements noted above, focusing variously on the individual and the environment; community approaches to prevention in alcoholism and other fields; and methodological issues that affect the feasibility of research and the quality of evidence it produces. Part I concludes with the committee's overall recommendations on the future course of prevention research. The Epidemiology of Alcohol-Related Problems Alcohol use has been associated with a wide range of physical and social problems, including disease, accidental and intentional violence, homelessness, unemployment, and -2

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marital discord. Injuries are a leading cause of morbidity and mortality in the United States, and alcohol is involved in many of them. For example, up to 50 percent of fatal automobile crashes involve alcohol and result in more than 20,000 fatalities annually. Alcohol also has a demonstrated association with risk of injury from falls and drownings, and about half of all fire and burn deaths are associated with alcohol use. Yet proving a causal role for alcohol in traumatic events or determining the magnitude of the relationship is difficult; owing to methodological problems in the designs of many of the studies used to support the contention of causality. Ideally, the most persuasive evidence would be provided by studies that compare exposure to alcohol (blood alcohol levels) among injury victims with exposure among comparable, uninjured persons who are selected for study when they appear at a later date at the same site and at the same time of day that the original incident occurred. Studies of this type, however, are logistically difficult to execute and therefore infrequently undertaken. Other methodological difficulties encountered with study designs include the proper determination of cases, measurement of the extent of alcohol exposure, distortion of results as a consequence of interviewer biases, and determination of the temporal sequence of exposure and incident. These methodological problems also bedevil studies that have shown an association of alcohol with other physical and social problems. Alcohol is sometimes used by both perpetrators and victims of violent crimes and is often involved in unprofessional, unplanned property crimes. Moreover, some alcohol use is indicated in 35 percent of successful suicides. There is also a widespread belief that child abuse and neglect are associated with alcohol abuse; however, this association is unproven and should be investigated further. Similarly, studies are warranted on the influence of alcohol on sexually transmitted diseases and sexual activity, including early sexual activity and adolescent pregnancy. One problem of particular concern has been the effects of alcohol on unborn children. Fetal alcohol syndrome (FAS) is a cluster of permanent physical deformities and mental retardation that result from drinking during pregnancy. There are one to three FAS babies for every 1,000 live births. In addition, some children exhibit mild physical and mental deficiencies following prenatal alcohol exposure; these kinds of abnormalities are called fetal alcohol effects (FAE). The role of epidemiological research in the prevention of alcohol problems is important in defining the extent and prevalence of the various problems that need to be addressed. Also of value in prevention is a consideration of the interaction of the various factors researchers believe may contribute to the development of such problems. The discussion that follows describes three avenues of research that share a common focus on the individual in their exploration of antecedents of the heavy use of alcohol. Individual-Environment Interactions: Focus on the Individual There are obviously many possible approaches to prevention research from the point of view of the individual alone. The three chosen by the committee are illustrative of the interactive perspective it believes is most fruitful for further research, that is, the individual in the context of his or her environment, both the specific drinking milieu and the broader developmental setting of the maturing person. -3

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adults. The Life-C;ourse Developmental Perspective The first approach, the life-course or life-span developmental view of individual vulnerability, attempts to link age to drinking behavior and to specify the pathways and interactions that both predict and cause drinking problems. Researchers have used this concept to construct analytical frameworks to investigate individual vulnerability to alcohol problems and, in particular, the heavy use of alcohol. Recently, researchers have suggested that certain interactions between risk factors in an individual (e.g., neurophysiological variables, temperament, behavior) and factors in his or her environment (e.g., life events, family, peers, work) contribute to the development of alcohol problems. Identifying those risk factors is important for devising effective prevention programs. Prospective studies of a cohort or generation of individuals offer a powerful tool for risk factor identification. Such studies follow a selected group of people, interviewing them at various points in their lives, to track the development or, often in later years, the lessening of alcohol problems. Several consistent findings have emerged from the few available prospective studies that have examined the antecedents of the heavy use of alcohol: antisocial behavior during childhood has been shown to be related to adult alcohol problems; aggressive behavior and the combination of aggressive and shy behavior in first grade have been found to predict heavy alcohol use at ages 16 and 17; and males judged to be shy as children were least likely to become alcoholics as Other factors that have frequently been found to predate adverse alcohol outcomes include difficulty in school achievement, inadequate parenting, hyperactive behavior, heightened marital conflict in the childhood home, and, among males, weak interpersonal ties. Recommendations for the next stage of prospective research that would lead to improved approaches to developmentally oriented interventions include ~ follow-up studies of cohort members to assess intermediate outcomes and stages along developmental paths; studies of the factors that influence heavy use and abuse of alcohol both within individuals and across different environments; and studies of transitions in stages of development as times of potential vulnerability to alcohol-related problems (e.g., going to school, entering the work force). The committee also recommends continued maintenance and expansion of existing longitudinal data bases as particularly valuable to prospective research efforts. Social Learning Models The social learning perspective on prevention research is the second approach selected by the committee for detailed review. Social learning approaches rest on the processes by which individuals acquire and maintain behavior. They can be coordinated with other models of the avenues leading to alcohol abuse because they incorporate (1) the individual's -4

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innate biological vulnerability as well as the experience he or she acquires during the course of development; (2) immediate environmental antecedents and consequences of behavior; and (3) cognitive processes whose presence or absence can explain, or be used to prevent, some alcohol-related behaviors. The central assumptions of the social learning perspective predict multiple pathways to alcohol use. They propose that alcohol use abuse and alcohol-related behavior are learned within a cultural context and superimposed on an individual's biologically determined predisposition to problems with alcohol, if any. One major part of this approach that sets it apart from many others is that the individual is viewed as an active agent in the learning process; thus, persons who have learned to misuse or abuse alcohol can also learn self-regulation of alcohol use. Specific cognitive information-processing mechanisms--an individual's beliefs, expectations, coping skills, and perceptions of self-efficacy--play a central role in regulating alcohol-related behavior. Understanding these mechanisms is essential for developing effective prevention programs. Promising approaches for prevention include training in social and coping skills and in self-management techniques such as self-monitoring (e.g., to estimate blood alcohol levels) and cognitive restructuring. A behavioral approach can also be used: the behavioral model assumes that many individuals who do not have severe alcohol problems can learn to stabilize or reduce their drinking by acquiring alternative coping skills, changing life-style habits, and learning safe drinking practices. Individuals go through predictable stages of readiness to change; these stages can be exploited to teach people the basic principles of habit change by means of self-help or media-assisted protocols. Research suggestions for testing the social learning model include the following steps, which are geared toward answering a number of specific questions that it raises: describe the reciprocal interactions among behavioral, cognitive, and environmental processes; design experiments that explore the role of beliefs and expectations in the acquisition of problem drinking practices, as well as the relevance of self-efficacy in prevention; and ~ explore the motivational factors underlying the stages of readiness to change. Genetic Determinants of Risk Major research efforts are continuing on projects to identify the genetic factors that may predispose an individual to alcohol abuse or dependence. However, there have been no major developments since the publication of IOM's first report, Causes and Consequences of Alcohol Problems, in 1987. Progress toward identifying chromosomal markers and genes that confer vulnerability were discussed in that volume. At present, the single best predictor of alcohol dependence is family history, although not all children of alcoholics are at equal rise The basis of the differential risk is not yet understood; consequently, research on targeted interventions does not appear to be indicated at this time. A consideration of the genetic determinants of risk, as well as what can be learned from the life-course developmental and the social learning approaches to prevention research, focuses on the individual in the public health equation of the development of alcohol problems. A different vantage point next is provided: the role of the drinking environment in the interactions that lead to alcohol problems. 5

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Individual-Environment Interactions: Focus on the Environment Many factors in the environment influence the choices that individuals make about their drinking practices. (In its use of the term environment here, the committee refers to the drinking setting and the cultural and economic milieu surrounding alcohol use.) The manipulation of these factors has been seen as useful in efforts to prevent alcohol-related problems. For example, there is a positive association between alcohol availability and consumption. Studies have shown that a higher minimum age of purchase can reduce consumption by young people and may reduce alcohol-related traffic accidents. (Actual reductions, however, appear to be a function of compliance by retail establishments and enforcement by authorities.) In addition, alcoholic beverage sales are sensitive to price, and a relationship exists among the price of alcoholic beverages, alcohol consumption, and alcohol-related problems. Researchers differ, however, in their estimates of the levels of price sensitivity of different beverages for purchasers of different ages. Research opportunities to investigate aspects of environmental controls on the availability of alcoholic beverages include identifying the effect of retail price on heavy, high-risk drinking; investigating the role of location, density, and hours of sale of alcohol outlets; and determining the effect or effects of pricing strategies. The standards of a community, both explicit and implicit, play a large role in shaping behavior and determining alcohol availability and consumption. The media play their parts in significantly affecting public perceptions of norms of alcohol use. Alcohol-related information is conveyed primarily through three modes: (1) public information campaigns, (2) commercial advertising by the alcohol industry, and (3) fictional television and movie programming that depicts drinking. The effective use of counteractive media can be an important component of a prevention effort, especially for young people who are major consumers of media offerings. Other aspects of the so-called drinking environment can also be brought into play to prevent adverse consequences of alcohol use. For example, both the law and social pressure can be used to reduce the number of drivers who drink. Studies are needed to assess the effect of changes in speed limits on the number of drunk-driving accidents and to explain the decline in fatal crashes in the early 1980s. Another promising legal strategy that needs evaluation involves the drinking context. Several states or jurisdictions have passed server liability statutes, malting those who serve alcoholic beverages liable for the actions of their patrons. This liability has led to server training in assessing patron consumption, interventions by servers, and planned changes in the drinking settings of establishments that serve alcoholic beverages. The workplace as a drinking setting offers another promising avenue of prevention research--promising in terms of both the knowledge to be gained and the reduction of costs incurred when employees have alcohol problems. More studies of the social organization of the workplace are needed to explain differential rates of drinking problems. In considering the workplace as a setting for alcohol consumption, individual heavy drinking may be viewed as a cultural effect, a group response to work conditions, or a consequence of individual proclivities. Research should be directed toward discovering the extent to which occupational drinking groups evolve and the determinants of affiliation with such groups. -6

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Focusing on the environmental influences that shape drinking behavior seems to lead naturally to the possibility of community-wide programs or strategies to reduce alcohol problems. Several large-scale programs have been developed for other aspects of health behavior, and their implementation has included an evaluation component. These approaches and their potential relevance to alcohol problems are discussed below. Community Approaches and Perspectives from Other Health Fields As a result of several community-wide prevention programs that incorporated sound research designs, significant changes have been made in the health behavior of program participants. Although the studies were conducted to alter unhealthful behaviors other than alcohol abuse, the lessons learned from these efforts and the strategies used may be applicable to the prevention of alcohol-related problems. Do studies have attempted to alter community risk factor profiles for cardiovascular disease (CVD). The Stanford Three-Community Study conducted during the 1970s provided evidence that community-wide health education involving mass media and supplemental face-to-face instruction can be effective in changing behavior and thus reducing CVD risk factors. The study, which was conducted over three years, used the three communities as different experimental conditions: in the first town, the program was carried out through the mass media alone; in the second, mass media techniques were supplemented with intensive face-to-face instruction; and in the third, no program was instituted at all. The results of the educational program components were assessed over time by using a multiple logistic function that incorporated age, sex, plasma cholesterol, systolic blood pressure, relative weight, and smoking. During a two-year period, in those towns in which the program was presented, a statistically significant reduction was achieved in the community's composite risk score for CVD as a result of significant declines in blood pressure, smoking, and cholesterol levels. Even greater reductions were seen in the town in which face-to-face instruction was used. The Stanford Five-City Project is an ongoing 13-year study involving two intervention and three control communities that began in 1978 as an outgrowth of the Three-Community Study. Although the primary goal of the Five-City Project is to reduce the risk of CVD, other important subsidiary goals include an analysis of the program's cost-effectiveness, development of educational and community organization methods, transfer of control to community organizations, and measurement of morbidity and mortality. Interim results of the project show a promising reduction in risk factors. The next step should be to learn how to replicate these results in disorders other than CVD. The lessons learned from these studies can be summarized as follows: Theory should be used as a basis for program planning, implementation, and evaluation; in addition, drawing from several disciplines may increase the strength of the theoretical framework that eventually results. . A comprehensive, integrated program is needed when the target of the intervention is an entire population rather than high-risk individuals alone. Formative and process evaluation is required. In the Stanford studies, such evaluation included needs analysis, pretesting of educational programs, and analysis of the implementation process following the introduction of the programs into the community. -7

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. An extensive evaluation of outcome is essential and must be conducted using validated measures of the occurrence of risk-related behaviors and behavior change. These evaluations should include three levels of analysis: the individual, organizations, and the community. There have also been successful campaigns in several other health-related areas. For example, a campaign to promote seat belt use indicated that legislation combined with work site-based incentives and education could promote some types of behavior change. A cancer prevention program sponsored by the National Cancer Institute in collaboration with the Kellogg Company provoked a demonstrable interest in dietary change. Some smoking prevention and cessation programs have achieved a degree of success. In addition, there have been several school-based programs that have apparently reduced adolescent pregnancies. The guiding principles offered by these campaigns, which may be applicable to programs to prevent alcohol problems, include the necessity to establish multiple outcome objectives and to design programs to meet the needs of the target population. Furthermore, these programs show that a potential exists for a beneficial, synergistic effect when several approaches are combined--for example, in the case of seat belt use, both legislation and education. The growing evidence of success in these other fields makes it probable that the prevention of some alcohol problems can be effected through the use of similar methods. The . . _ generalization of principles from these efforts should be a carefully planned endeavor involving formative evaluation, pilot testing, behavioral analysis, and the critical review of research. In addition, the methodological issues noted below must be addressed. Methodological Issues in Alcohol Prevention Research: Conclusions and Recommendations There is no single research design or analytical strategy that has characterized prevention research on alcohol problems. A variety of approaches can be used depending on the goals of the research, the setting afforded, and the amount and type of variation to be controlled or explained. A frequently encountered difficulty is that much prevention research must be conducted outside the laboratory, raising issues of feasibility, cost, precision, and validity. Yet both laboratory and field research are needed; in fact, the validity of conclusions is strengthened when consistency is demonstrated between the two approaches. In recent years, alcohol prevention research has made use of a variety of qualitative and quantitative methods in both of these research domains, including quasi-experimental designs, which are frequently used because of the difficulties involved in the random assignment of subjects in field research. The committee formulated a number of recommendations for future alcohol prevention research programs that can be summarized as follows: Findings from biomedical research should be integrated with theories from the social sciences that seek to explain alcohol use and abuse. Integrated models can then be used to guide the development of prevention interventions. . Theory-driven research should be promoted. Its development can be aided by borrowing theory-based analogues from studies in other health fields. Life-span considerations and developmental factors should be incorporated into comprehensive theories of research that draw on work in any of the fields applicable to alcohol problem prevention. If specific interactions between individual characteristics and -8

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environmental or cultural demands are predicted to produce a group at risk, such predictions can be used to plan and test preventive strategies. Collaboration among scholars from diverse fields should be encouraged in theory development. These fields might include the biomedical sciences, psychology, sociology, anthropology, clinical epidemiology, education, econometrics, and any other disciplines shown to be relevant. Program planning and implementation should be integrated with evaluation. Pilot studies of untested components of programs (formative research) should be increased. One barrier to community prevention research has been the cost of collecting the data NLAAA mav want to necessary to measure whether an intervention was effective. encourage local and county agencies to develoD information management systems that can . . ~~ ~~' ~~~~~~~~ ~~ ~ r ~ -^-^--0~ v~v._~^v ...~.~., serve as data bases. Long-term community trials of prevention strategies should be instituted. Prevention research should inform policy formation. In particular, prevention research must develop the necessary methods and techniques to help prevention planners estimate the potential effects of various interventions, based on the best available research. Prevention research should include a consideration of cost-effectiveness in evaluations of interventions. Together, the committee's recommendations present an ambitious program for the coming years that, if implemented, may help to substantially reduce the human and economic burden of alcohol problems. The pursuit of such an outcome, however, also requires a complementary consideration of the research opportunities to be found in treatment of alcohol problems. These opportunities are discussed in Part II of the report. RESEARCH OPPORTUNITIES IN THE TREATMENT OF ALCOHOL PROBLEMS After brief mention of some of the historical factors in treatment research the committee ~ . . ~ .. .. . alvlues Its discussion of treatment research opportunities into a number of areas: issues of assessment, methodology, and research design; treatment modalities; early identification and treatment; patient-treatment matching; advances in the treatment of other psychoactive substance-use disorders; the health consequences of alcohol abuse; and the public policy considerations that attend treatment costs, benefits, and cost offsets. Historical Factors in Treatment Research During the past few years, a variety of factors, many of them outside the realm of the academic scientific community, have influenced the course of alcohol treatment research. Some of these factors, which will continue to influence future research efforts, are described briefly below. Federal involvement in alcohol treatment is changing. After a period in which it supported mainly biomedical and psychosocial research, NIAAA has indicated renewed interest in treatment research by creating the Division of Clinical and Prevention Research and by making new funds available for research projects. New trends are emerging in the financing, size, and public/private ownership of alcoholism treatment services. These shifts include changes in reimbursement policy, the expansion of inpatient treatment, increases in the number of for-profit treatment providers, the growth 9 1

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of Alcoholics Anonymous (AA), and the emergence of nontraditional sources of recruitment into treatment (e.g., media advertising, employee assistance programs, drinking-driver programs). Demographic trends in the general population have important implications for the demand for alcohol-related health services. Alcohol abuse and dependence reach their peak prevalence between the ages of 35 and 45. Maturing of the baby boom population means that an increasingly larger proportion of the population is passing through this period of greatest risk; moreover, alcohol problems already were among the most prevalent problem conditions, compared with other medical or mental disorders. Other demographic trends that may influence the demand for treatment services include changes in the nuclear family, increases in the number of homeless persons, aging of the population, and deinstitutionalization of psychiatric patients. The methods that are currently available for assessing a community's need for alcohol treatment services have improved but still require refinement. Popular trends in treatment and referral may have a profound effect on the treatment-seeking population as well as on the treatments being delivered. The past decade has seen the emergence of public interest groups dedicated to the prevention and prosecution of drunk driving, Americans' increasing health consciousness, a decline in the public's preference for distilled beverages, and an increased awareness of the hazards of heavy drinking. The emergence of the trends noted above, as well as the shifts or changes in those factors that have traditionally influenced treatment research, offer increased opportunities for policy-oriented studies. Such work might include research on the economic forces shaping the demand for, and provision of, treatment services; the geographic distribution of treatment; reliable and valid techniques of prevalence assessment; popular trends and concepts in the field; alternative treatment systems; and outcome monitoring of samples from multiple facilities. The development of data bases is another fruitful area: data are needed to track emerging trends in patient characteristics, population demographics, alcohol use, and utilization of services. There have already been notable achievements in the area of treatment evaluation. Some of these advances are discussed below, together with several of the major, unresolved evaluation research issues. Conceptual and Technical Advances in Assessment Alcohol dependence is now viewed as one core syndrome within a broader spectrum of alcohol-related problems. A distinction is made between alcohol dependence, which is seen as a coherent syndrome, and alcohol-related disabilities, which are considered to be a heterogeneous set of physical, psychological, and social impairments that occur independently of alcohol dependence. In research terms, this distinction means that assessments should focus both on dependence and on the problems that may or may not be associated with it. Alcohol dependence itself is viewed as a continuum from relatively mild to severe that can be measured by diagnostic criteria and by the use of assessment instruments. Significant advances have been made in new techniques for screening, diagnosis, and differential assessment. The third edition of the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders (DSM-III) has had a major impact on the classification of mental and substance abuse disorders in general; in addition, it has -10

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fostered further development of structured diagnostic interviews as assessment instruments. Together, these two advances have had a significant effect on the way clinicians make diagnoses and have improved diagnostic reliability in the alcohol field. In addition to progress in diagnosis, there have been advances in basic research that have begun to stimulate new approaches to assessment and patient treatment placement. Differential assessment requires a detailed evaluation of a patient's alcohol-use disorder including etiology, presenting symptoms, substance-use patterns, and alcohol-related problems. This is crucial to individualized treatment planning--the so-called matching of individuals to specific kinds of treatment. In the past decade there has been a growing interest in the development of questionnaires, interviews, performance tests, personality inventories, and biological tests designed to assess the extent of a patient's disorder and to quantifier alcoholism as a multidimensional clinical disorder. Instruments have been developed that can generate reliable, standardized information for research. Another assessment technology in which there has been great interest is the development of laboratory tests that detect alcohol consumption. The presence of alcohol in blood, urine, breath, or sweat is evidence of drinking. However, owing to the relatively short half-life of alcohol once it is ingested, alcohol tests using blood, breath, or urine cannot indicate chronic alcohol use. Other biological markers for drinking are currently being tested but are not yet sensitive enough to be used alone to monitor treatment outcome. Questions have been raised about the validity of verbal data obtained from persons with alcohol problems. Such data are inherently neither valid nor invalid; they vary in validity with the methodological sophistication of data-gathering techniques and the personal characteristics of the respondent. Methodological problems with self-reported data span all of the disciplines that must rely on this technique; research is required to improve the procedures for gathering valid verbal report data. Advances in assessment techniques have contributed to a more accurate estimation of the relative contributions of client characteristics, therapeutic interventions, program settings, and environmental variables to the success or failure of treatment, that is, to its outcome. Yet more research is needed to identify the active ingredients of traditional and experimental treatment interventions in order to match individuals to the treatment that will be the most effective (produce the best outcome) for them. There has been little evaluation of the short-term impact of specific treatment components (e.g., alcohol education, AA groups, individual counseling); consequently, there is a strong need to use newly developed techniques that specify treatment quality, process, and outcome in order to identify the active ingredients of treatment interventions. In recent years, increasingly sophisticated methodological approaches have been developed for use in alcohol treatment evaluation. Research findings from preclinical, experimental, quasi-experimental, and descriptive research should lead to the identification of the active components of treatment. Indeed, evaluation research holds the key to advances in the therapeutic effectiveness of treatment for alcohol problems. Effectiveness of Treatment Modalities: Studies of Process and Outcome Since 1980 more than 250 new studies have been published reporting outcome data on various approaches to the treatment of alcohol problems. Some of the areas covered include pharmacotherapies (antidipsotropic, "effect-altering," and psychotropic medications), -11

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aversion therapies, psychotherapy and counseling, didactic approaches, mutual help groups, behavioral self-control training, conjoint therapies, broad-spectrum treatment strategies, and relapse prevention procedures. Behavioral self-control training is the single most studied modality since 1980, but the evidence for its effectiveness is mixed. Recent research on conjoint therapies suggests that interventions to improve the functioning of couples and families may enhance favorable outcomes. However, only couples therapy has been systematically evaluated; the effectiveness of whole-family therapy is unknown. Another promising direction is toward the use of appropriately planned broad-spectrum strategies. These methods address not only alcohol consumption but also other life problems and have been associated with lower rates of relapse to alcohol abuse. Typically, alcohol treatment programs in the U.S. offer a combination of modalities that include detoxification and health care, AA groups, lectures and films, group therapy, individual counseling, recreational and occupational therapy, medication, and aftercare group meetings. High success rates for such programs are sometimes claimed, but scientific evaluation of these traditional, multicomponent endeavors is lacking. (It has been limited to uncontrolled studies, which are difficult to interpret). The absence of random assignment and control groups means that absolute effectiveness cannot be inferred. Increased attention should be devoted to the possibility of conducting controlled trials in a broad range of facilities. One aspect of treatment research for which controlled trials have been conducted is the intensity and duration of treatment. Controlled studies of mixed (unselected) populations of alcoholics have found no differences in outcome based on these factors. Similarly, the overall effectiveness of treatment with unselected patients appears to be no different in residential or nonresidential programs. It seems likely that certain subpopulations of alcoholics would benefit differentially from longer, more intensive treatment or from hospital-based programs. For example, data suggest that intensive residential treatment may be warranted for socially unstable individuals or for those with more severe levels of alcohol dependence or psychopathology. They also show that aftercare designed to maintain the results of treatment has been shown to increase residential treatment effectiveness. Whereas outcome research provides data on the overall impact of therapeutic interventions, process research investigates the underlying elements involved in treatment, that is, the active ingredients of treatment efficacy. Some of the variables that have been investigated in this regard are motivation, compliance, mandated treatment, and therapist skills and characteristics. One of the more interesting findings in this area indicates that for some individuals, change can occur with minimal interventions (i.e., brief treatment strategies). The broader question being investigated through all of these studies is: Does treatment work? A meaningful answer must be sought from a number of different perspectives. Given the heterogeneity of treatment and the available research evidence, there is no doubt that all treatments for alcohol problems cannot be considered to be effective. If the question, however, is taken to mean, Are any of these treatments effective? then the answer is a more confident Yes. There is no guidance, however, from the literature indicating a single superior treatment approach for all persons with alcohol problems. The committee views the current array of treatment procedures optimistically and is encouraged by the opportunities for continued research to improve the effectiveness of treatment. -12

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Early Identification and Treatment Since 1980 increased attention has been given to the identification and treatment of individuals early in their development of alcohol problems. Low-cost interventions based on self-help manuals or brief counseling may be effective as a first attempt to intervene with a large number of people who drink heavily but who show little or no dependence on alcohol. Indeed, current data indicate that brief interventions are superior to no treatment or to waiting list status. Thus, in experimental study designs, the use of research-supported brief intervention comparison groups can circumvent the ethical dilemma of refusing treatment in order to form control groups. Brief and early interventions are also being investigated for use with pregnant women to prevent both fetal alcohol syndrome and fetal alcohol effects. The development of early identification and treatment procedures implies that the reduction of alcohol consumption to low-risk levels--rather than abstinence--is a worthwhile goal within certain contexts and populations. Consistent with the picture of alcohol problems as a continuum from mild to severe, a goal of moderation is seen as being most feasible toward the milder end and abstinence most vital toward the severe end, with a large gray area between. The question of "appropriate" goals for treatment outcome is complex, however, as well as emotionally charged and highly controversial within the alcohol treatment community. The contraindications for specific treatment goals are an important area for future research. Effective, inexpensive early interventions are still in the early stages of development. Whereas promising results have been reported from a few programs, there have been little rigorous evaluation and few studies on the behavioral processes that may underlie the effectiveness of such strategies. In addition to the research needed in these areas, further exploration of screening, recruitment, and implementation processes is important. For example, more research attention should be devoted to the evaluation of low-cost, rapid screening procedures that can be used routinely by primary care practitioners. In fact, if studies continue to show the effectiveness of early identification and treatment, the training of health care professionals in screening and brief intervention and the development of materials for continuing education are certainly warranted. Patient-Treatment Matching and Outcome Improvement in Alcohol Rehabilitation In the past 10 years, matching patients with treatments has been recognized as a sophisticated idea with as yet untapped possibilities for improving the effectiveness and efficiency of treatment. One major area of work on this topic has been the investigation of basic patient characteristics that generally predict outcome (i.e., the Success or ~failure" of treatment) across a variety of treatment modalities. Four patient variables appear to be generally predictive of treatment outcome: (1) social stability/social supports (fewer supports result in worse treatment response generally but especially in outpatient treatment); (2) psychiatric diagnosis including severity/number, duration, and intensity of symptoms (greater severity indicates generally worse treatment response); (3) severity of alcohol use/severity of alcohol dependence syndrome (greater severity means worse treatment response); and (4) presence of antisocial personality disorder (generally indicative of poor treatment response). From research of this kind have come matching strategies -13

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that (1) permit patients to select among alternative treatments (the "cafeteria" approach); (2) employ feedback designs which generate testable hypotheses (patients are assigned on the basis of "statistical hunches" to a particular treatment); and (3) test the effects of the addition of an element to the usual treatment. Effective matching requires clear specification of the characteristics of individuals seeking treatment and of the components of particular treatment approaches. There have been a number of advances in such measurements, but more research is required. Analysis of defined stages of rehabilitation or treatment (rather than of detoxification or maintenance following treatment) offers great potential for refining the process of optimal treatment selection. Opportunities exist for matching before treatment or rehabilitation starts (i.e., in the treatment selection process), a point that might be particularly appropriate for such populations as adolescents, Native Americans, women, homeless men, the elderly, and so on. Matching to an appropriate level of treatment intensity can also take place at the initiation of treatment; matching to specific treatment components can occur during the treatment process. Some studies have already been conducted in these areas, but more efforts are needed to clarify and further refine existing data, particularly in the case of treatment components. Matching to a particular posttreatment environment for aftercare should also be investigated. Advances in the Treatment of Other Psychoactive Substance-Use Disorders: Implications for Alcohol Treatment Research There are many parallels between alcoholism and other addictive disorders, although treatment for alcohol problems has often developed in isolation. In addition, there is a significant comorbidity of dependence on alcohol with dependence on other psychoactive drugs, including nicotine. Both the presence of comorbidity and the parallels that are known to exist suggest the possibility of applying treatment methods used for other substance-use disorders to the treatment of alcohol problems. They also suggest the importance of research into the common processes that may underlie these dependence ~C, 1 J - r r J O disorders and the need to develop effective approaches for treating multiple problems within the same treatment protocol. Several common foci have characterized recent research in psychoactive substance-use disorders. Common theoretical issues include the processes and stages of change, relapse, coping skills, and conditioning factors. There are also several treatment approaches that have been applied to the treatment of more than one psychoactive substance-use disorder (e.g., combining pharmacotherapies with psychological treatments, using treatments based on social learning principles, brief physician interventions, and self-help groups). There are a number of approaches that have been applied rather extensively in treatment of other substance-use disorders but that have yet to be studied in detail in relation to alcohol treatment. These methods include procedures for self-directed change, behavioral approaches, change process research, psychotherapy using state-of-the-art research methods and well-specified treatment protocols, and pharmacotherapeutic approaches to treatment. These studies offer reason for optimism in that (a) formal treatment makes a difference in the rate of successful change seen in individuals who undertake it, (b) differential effects of different treatments have been demonstrated, and (c) a variety of methods are being developed. -14

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Health Consequences of Alcohol Abuse Alcohol abuse has diverse deleterious effects on health, including those resulting from intoxication, the withdrawal syndrome, and many Apes of organ damage. Hepatic cirrhosis could be considered the most serious alcohol-related medical disease because it has the highest mortality. Yet the cognitive impairment induced by alcohol abuse is also a serious concern because it impedes daily functioning. The committee, in response to its charge, focused on opportunities for research on the treatment of alcohol-related illnesses. It reviewed research in such areas as pharmacological and nonpharmacological detoxification, treatment of seizures and delirium tremens, treatment of postwithdrawal symptoms (sleep disorders, nervous system effects), and cardiovascular and liver effects. There has been some progress in treating certain alcohol-related illnesses, but other disorders still have no specific treatment. Generally, in treatment for alcohol-related illnesses, treatment of the abuse of alcohol is paramount for the prevention and containment of alcohol-related organ pathology, and abstention is essential to the possible reversal of organ damage and to inhibit the progression of cellular and tissue damage. In some of the study areas noted above, multisite studies of treatments for alcohol-related health consequences are essential because the low frequency of illness results in insufficient numbers of study subjects. Alcoholic hallucinosis, pancreatitis, and cardiomyopathy are examples of disorders whose understanding might require multisite research efforts. Controlled treatment trials of detoxification or research on ways of limiting or reversing cognitive impairment could be carried out at either single or multiple sites. Treatment Costs, Benefits, and Cost Offsets: Public Policy Considerations The final topics in the committee's review of research opportunities related to alcohol treatment are cost and public policy considerations. Traditionally, the criteria used in studies of this kind have been those that measured changes in the potential of the system to cure disease. In the past 20 years, a counterinfluence has developed: the primary (or even exclusives use of economic criteria. Neither of these approaches, however, is sufficient on its own to deal with the complexities of the policy issues that surround treatment for alcohol problems. Public policy research can take a variety of forms. For example, policy analysis entails a review of what is known about a subject in order to consider policy alternatives systematically. There are few good policy analyses of the costs and benefits of alcohol abuse treatment, and more are needed. Another strategy is to foster the inclusion of cost of treatment as a variable within alcohol treatment evaluations. an anDroach that would lead to important research opportunities. ---I -- -rr ~^ ~ Cost offset studies measure posttreatment health care costs (including the cost of ongoing alcohol treatment) incurred by treated alcoholics and compare them with the total health care costs this group would have incurred if no alcohol treatment had been received. The studies using this method that have been conducted thus far suffer from certain methodological problems; nevertheless, they suggest that alcohol treatment contributes to sustained reductions in total health care utilization and costs. A question of great interest is the extent to which coverage for alcohol treatment might actually stimulate the use of other health care services, thereby improving the patient's condition and reducing his -15

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overall use of general medical services in the long run. An ideal cost-offset study to investigate such an issue would include no-treatment controls, but the legal, ethical, and methodological difficulties of conducting this type of effort are formidable. Still, research that moves as close as possible toward this true experimental strategy should be encouraged. There are two other important areas of current policy interest in which practically no research has been conducted on the cost-effectiveness of treatment The first is insurance-related factors: the effect of different insurance benefits on entry into treatment, the selection of a specific treatment modality, consumer satisfaction, and the ultimate cost of the system. There is also a need for research that compares payment sources. For example, research on different benefit programs offered by a single employer is a promising area for comparison studies (by payment source) of the effect of treatment on utilization. In addition, employee assistance programs provide an opportunity to answer questions about the costs and effectiveness of certain treatments. The other area in which almost no research has been conducted is managed care programs, an increasingly common addition to health care benefits. Managed care programs provide information to help in the selection of treatment options, typically through review procedures that specify the conditions under which treatment must be delivered, thus attempting to prevent unnecessary treatment. These specialized cost-containment procedures include hospital preadmission review, continued stay review, mandated second opinion programs, discharge planning, major case management, and alternate service recommendations. They may be provided by a peer review organization, by health insurance company staff, or by private case management companies. The roles of public and private financing for alcohol treatment are an important policy question. Increased private expenditures for treatment may result in public cost offsets (e.g., decreased criminal justice costs, fewer motor vehicle accidents) but not necessarily in private cost offsets. More research is needed to provide policymakers with the necessary information to make financing decisions that promote the equitable provision of cost-effective, appropriate treatment services. FUNDING MECHANISMS AND THE NECESSARY INFRASTRUCTURE FOR TREATMENT AND PREVENTION RESEARCH Exploitation of the research opportunities identified by the committee in this report will depend on adequate funding and an appropriate research infrastructure (i.e., personnel, facilities). Over the past decade, there have been substantial increases in the federal alcohol research budget. NIAAA has relied on two mechanisms for funding treatment and prevention research, the investigator-initiated grant and the research center. Research support by NIAAA and the Veterans Administration (VA) has led to improvements in methodologyand theory, as well as an expansion of the pool of researchers and facilities. More remains to be done, however, and Part III of the the report discusses the issues involved in supporting the scientific research infrastructure. Supporting the Scientific Infrastructure for Prevention Research Prevention research now constitutes approximately 9 percent of NIAAA's total extramural research/research training budget. In earlier years, allocations for prevention research funds -16

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were based on NIAAA's perceptions of the effectiveness of various intervention strategies; because little effort was made to ensure sound evaluation, there was limited conclusive information forthcoming about outcomes or intervention efficacy. Yet much has been learned since the 1970s about outcome evaluation; the experiences of the National Heart, Lung, and Blood Institute (NHLBI) and the National Cancer Institute (NCI) with demonstration and educational research grants have yielded fresh insights into ways that future alcohol prevention programs might be designed, implemented, and evaluated. In particular, the use of prevention trials to evaluate intervention effectiveness should become an established tradition at NIAAA. Significant opportunities now exist for NIAAA~ational Institute on Drug Abuse (NIDA), and the Office of Substance Abuse Programs (OSAP) to conduct controlled prevention demonstration projects with well-designed prevention components. ~ - ~ ~ ~~ ~ ~ ~, . . . . ~ . ~. . Furthermore, when funding of prevention aemons~rauon projects Is allocated In the future, money should be set aside for the joint design and evaluation of prevention trials by NIAAA, NIDA, and OSAP. The venous mechanisms currently in use by NIAAA for funding such research appear to be appropriate for most basic and applied prevention studies. Such investigations should include pilot projects, prototype studies, controlled intervention trials, and studies of defined populations. However, for major preventive trials (i.e., comprehensive, multiyear efforts that often involve several research sites or centers), the committee recommends the development of special funding mechanisms, such as a separate budget line item. Also required for all of these studies are certain infrastructure elements, for example, the development of expertise in outcome evaluation and a support mechanism responsive to community initiatives that represent new or unique research opportunities. A research strategy that will lead to effective prevention programs will require collaborative designs and coordinated analyses. The committee suggests the development of a system that connects research groups in cooperative studies to combine individual strengths and support strong theoretical and methodological integration. It also suggests that NIAAA explore various mechanisms to provide leadership in this area. The committee recommends that NIAAA continue to promote collaborative prevention strategies and new prevention research initiatives. Supporting the Scientific Infrastructure for Treatment Research Although federal alcohol research funds in general have increased over the past decade, it was not until 1988 (when NIAAA created its new Division of Clinical and Prevention Research) that treatment research was accorded more stature in the overall federal alcoholism research program. As a consequence of the earlier lack of attention, there have been few controlled studies of treatment modalities or settings in relation to outcome. Treatment research methods are often shaped by the requirements of the treatment program, which may limit the rigor of the research design. Another limitation is the availability of trained researchers. The number of qualified treatment researchers needs to be increased by a variety of mechanisms, especially expanded support for postdoctoral training. One mechanism that is already in place but that could be more effectively employed in treatment research is the program of grants to NIAAA's 12 research centers. Only one of these centers currently conducts alcohol treatment research. NIAAA might consider funding additional centers devoted to treatment research, in collaboration with another -17

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federal agency. The centers might also offer an avenue for increasing the number of research personnel: with the expansion of treatment research at the centers, NIAAA could budget funds for additional trained staff. The committee commends the recent designation of set-aside funds within block grants for use in evaluating alcohol and drug abuse treatment programs and in assessing the quality of various forms of treatment. This policy could well encourage linkages among university-affiliated researchers, state agencies, and treatment facilities. One impetus for this change in focus is the fact that an appreciable proportion of alcoholism treatment now takes place in freestanding inpatient units that are largely unaffiliated with major academic or research centers. Strong interest has been generated in research on various treatment settings and the matching of individuals seeking treatment for their particular alcohol problem. However, to systematically examine treatment setting and treatment matching, it is essential to develop a pool of treatment facilities that are willing to participate in controlled treatment trials. Such trials also require that specific funds be set aside for thorough patient assessments at entry to treatment and at follow-up points; in addition, assessment reliability must be ensured both within and between sites. An excellent mechanism for this type of effort would be the Public Health Service's cooperative agreement. Indeed, the use of cooperative agreements to fund large-scale alcoholism treatment research should be encouraged. Staff of NIAAA could play a critical role in bringing together a network of investigators and a variety of treatment facilities from both the public and private sectors. Another promising mechanism for systematic treatment evaluation is the VA's collaborative study. However, the VA recently announced plans to curtail the availability of alcohol treatment, a policy that will have a devastating impact on treatment research in the alcohol field. Given the high percentage of veterans with alcohol-related pathology who are hospitalized in medical/surgical units in VA hospitals, the committee urges the VA to reverse these actions and renew its commitment to both alcohol treatment and treatment research. There appears to be sufficient flexibility in NIAAA's operational mechanisms to permit the implementation of most of the research opportunities outlined in this report. Over the years, the agency has developed a number of programs and activities that are capable of stimulating research and providing expert advice. As new funding and funding mechanisms are developed or become available, NIAAA should evaluate the experience of other agencies involved in clinical trials and large-scale collaborative studies. Their programs may serve as models for achieving some of NIAAA's goals; they may also indicate large areas of common interest. By coordinating activities among such interest groups as research centers, pharmaceutical companies, hospital chains, insurance companies, and state and federal agencies, NIAAA may be able to guide treatment research on alcohol problems along an increasingly coherent and productive path. -18

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I RESEARCH OPPORTUNITIES IN THE PREVENTION OF ALCOHOL-RELATED PROBLEMS

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Research related to prevention involves many different kinds of activities--from prospective cohort studies to studies of drinking environment and context, from studies of mass media campaigns to documentation of the effects of one-on-one counseling. Consequently, prevention researchers come from a number of different fields, bringing their own particular approaches and perspectives to an effort that is already multifaceted in terms of targets and methodology. As a way of organizing its work and providing a conceptual framework to examine a varied gathering of potentially fruitful avenues of research, the committee adopted a public health model in which three major elements--the individual, the agent (alcohol), and the environment-- all act together either to produce or attenuate alcohol-related problems. In assessing progress and opportunities in prevention research, the committee placed special emphasis in its deliberations on the interactive aspects of the model--in particular, the interaction of the individual and the environment--as the central feature of its framework. This is similar to the approach advocated in the National Research Council's resort. Alcohol and Public Policy: Beyond the Shadow of Prohibition (Moore and Gerstein, 1981~. In keeping with the varied nature of prevention research, it surveyed a wide range of disciplines for potential research opportunities, focusing particularly on those strategies and efforts that involved an interactive approach or perspective. With a scope of interest that encompasses a wide variety of disciplines and viewpoints, it is probably inevitable that conceptual differences are reflected in the problems that surround the use of certain terms. ~Environment" is a case in point. In its discussions, the committee used this owrd to mean both Environment in a specific sense--the drinking setting and the cultural and economic milieu surrounding the use of alcohol--as well as in the broader sense of the total developmental setting of a child. The committee has clarified whenever necessary its particular uses of this term. The prevention section of the report, Part I, is divided into six chapters. Chapter 1 presents a brief discussion of the public health model used to organize the rest of the discussion in the other chapters, along with a typology of interventions by target (e.g., total population, selected groups, high-risk individuals). Chapter 2 is an update and, in some cases, an amplification of the research presented in Causes and Consequences of Alcohol Problems (IOM, 1987) on the wide range of physical and social problems associated with alcohol use. This material refers mainly to prevention and early ~aen~r~ca~on or alcohol-related problems and not to research involving those who are already afflicted with severe problems or alcohol dependence. Chapters 3 and 4 present several intriguing avenues of research, concentrating particularly on those that explore the interaction of the elements proposed in the public health model. Chapter 3 uses the individual as the central organizing element, while Chapter 4 focuses on the environment. Chapter 5 details community approaches and perspectives from research in other fields; Chapter 6 discusses methodological issues in prevention research and offers several broad recommendations on research opportunities. . . . , As noted in the introduction to the report, little attempt is made here to address the implications of the research presented here for policymaking or for prevention program implementation at the grass-roots level. The diversity and complexity of the prevention research field dictated the committee's strict focus on the mandate it received from NIAAA to identify opportunities for research rather than applications of research for policymaking and program development. -20

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REFERENCES Institute of Medicine. Causes and Consequences of Alcohol Problems: An Agenda for Research. Washington, DC: National Academy Press, 1987. Moore, M. and D. Gerstein, eds. Alcohol and Public Polisher: Beyond the Shadow of Prohibition. M. Moore and D. Gerstein, eds. Washington, I:)C: National Academy Press, 1981. -21

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