New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions by Henrick J. Harwood, Tracy G. Myers (National Academy Press) Excerpt from Summary: New, improved therapies to treat and protect against drug dependence and abuse are urgently needed. In the United States alone, about 50 million people regularly smoke tobacco and another 5 million are addicted to other drugs. In a given year, millions of these individuals attempt—with or without medical assistance—to quit using drugs, though relapse remains the norm. Furthermore, each year several million teenagers start smoking, and nearly as many take illicit drugs for the first time.
Research is advancing on promising new means of treating drug addiction using immunotherapies and sustained-release (depot) medications. The aim of this research is to develop medications that can block or significantly attenuate the psychoactive effects of such drugs as cocaine, nicotine, heroin, phencyclidine, and methamphetamine for weeks or months at a time. The promise of the new medications rests not only on their longer action, but also on differences in the way they operate. Unlike most existing treatments, which are active in the brain itself, immunotherapies act by binding the drug in the bloodstream and preventing it from reaching the brain. This represents a fundamentally new therapeutic approach that shows promise for treating drug addiction problems that were difficult to treat in the past. Despite their potential benefits, how-ever, several characteristics of these new methods pose distinctive behavioral, ethical, legal, and social challenges that require careful scrutiny.
At the request of and with support from the National Institute on Drug Abuse (NIDA), the National Research Council and Institute of Medicine established the Committee on Immunotherapies and Sustained-Release Formulations for Treating Drug Addiction to develop recommendations for research in this emerging field. Specifically, the committee was charged with identifying and defining distinctive behavioral, ethical, legal, and social issues that are likely to arise if and when these medications become available for treating drug addiction. Such issues can be considered unique aspects of safety and efficacy that are fundamentally related to the distinct nature and properties of these new types of medications. The committee was not charged with determining whether or not immunotherapies and sustained-release formulations represented an efficacious approach for treating drug addiction. Nor was it asked to determine whether or not NIDA should continue to fund research on these types of therapies. Rather, the committee was charged with identifying and defining issues that are likely to arise if and when these medications become available. Essentially, the committee was charged with formulating a re-search agenda. The result of that work is presented herein. This research agenda has been informed by a series of commissioned papers, comments when these papers were presented at a public workshop, and the expertise and judgment of the committee.
The committee examined three different types of therapeutic agents: active immunotherapies, passive immunotherapies, and depot formulations of opioid antagonists. Active immunotherapies use periodic injections to stimulate the body's own protective immune system to generate antidrug antibodies, which then bind drugs of abuse in the bloodstream before they can reach the brain. Passive immunotherapies use preformed antidrug monoclonal antibodies that are produced through advanced biotechnology techniques; they also bind drugs of abuse in the bloodstream and can be infused for immediate treatment for drug overdose. Depot medications are long-acting formulations of existing drugs that are slowly released over time, typically administered as injections.
To date, the new medications have been studied primarily for their efficacy in the treatment of drug dependence, chronic drug use, and drug overdose. It is plausible that they will prove efficacious in protecting against initiation and escalation of drug use. However, the immunotherapies are still quite new, and there is very limited research. The research to date suggests that the concept might work, but that limited research does not constitute evidence that this therapeutic approach or any particular new molecular entity is safe or efficacious. Although there is much more research on depot medications against opiate addiction, the committee was also not charged with a review of the safety or efficacy of depot medications.
Immunotherapy and depot medications can block or significantly attenuate the psychoactive effects of drugs of abuse by either reducing the amount of drug in the brain (immunotherapies) or by blocking drug effects at their site of action in the brain (sustained-release medications). Research in both human and animal subjects demonstrates that consumption of a blocked drug can fall dramatically or even cease. Another important characteristic of these medications is that they have long durations of action—a month or even longer per administration—which should reduce the problem of nonadherence found with medications that must be taken daily.
Recommendation 1 The National Institute on Drug Abuse should support basic immunology studies on increasing the stability and longevity of antibody blood levels and on developing combination therapies to simultaneously treat a variety of abused drugs.
Clinical trials for Food and Drug Administration (FDA) approval of these medications will likely be performed in limited populations—such as adult males and nonpregnant females being treated for drug dependence or drug overdose—because the companies sponsoring such trials seek the least costly way to obtain FDA approval. Once a pharmaceutical is approved, however, the FDA has little effective control over the way it is used in the practice of medicine. However, it is foreseeable that parents and physicians will be interested in using immunotherapies "protectively" with children and adolescents—before they have ever used tobacco or illicit drugs or when use is still at subclinical levels of severity—even if these medications have not been approved for such purposes. Likewise, addiction programs with pregnant patients will be inclined to use these new medications despite the lack of testing in that population. The perception of potential benefits from protective use of immunotherapies for adolescents and pregnant women may be quite high, because the consequences of drug use or addiction can be long-lasting and severe in these populations, and they pose unique challenges. Moreover, the general record of safety of immunotherapies when established for some populations might lead health professionals to expect such safety for these therapies with populations not yet tested.
The potential unwanted behavioral responses from off-label uses of these new medications point to a need to consider expanding the criteria for evaluating pharmaceutical products by the FDA. The means now used by the FDA to measure safety and efficacy in clinical trials may not provide an accurate picture of the costs to society or benefits that these medications will produce in actual use.
Recommendation 2 Recognizing that immunotherapy and sustained-release medications will be used in off-label situations that have not been specifically approved by the Food and Drug Administration, the National Institute on Drug Abuse should support pre-clinical studies addressing the potential safety and efficacy of these medications when given to vulnerable populations (e.g., pregnant women and their fetuses, adolescents, etc.). Long-term studies should be done with laboratory animals of different ages, as well as their offspring, before trials with vulnerable human populations are undertaken.
Recommendation 3 The National Institute on Drug Abuse should support studies of the likely extent and nature of off-label drug use, including factors and incentives that would promote or retard such use, and the opportunities for policy makers to intervene should the patterns of off-label use depart from what is in the best interest of the society.
Immunotherapy medications present unique and far-reaching challenges for our current system of medical and addiction treatment. The development of these therapies highlights the need to view addiction as a chronic medical condition requiring long-term management. As such, they will require the historically separate systems of medical care and addiction treatment to forge new partnerships to ensure that both medication and integrated psychosocial services are available to those in need. Offering these treatments in primary care settings should reduce the stigma of substance abuse treatment, but the potential for long-term markers of these treatments or false-positive markers of drug use may discourage treatment participation.
Recommendation 4 The National Institute on Drug Abuse should support studies of whether the potential for discrimination due to long-lasting markers in the blood or urine deters people with drug dependence from accepting immunotherapies. The effects of immunotherapies on false-positive and false-negative drug testing results should also be studied.
Recommendation 5 The National Institute on Drug Abuse should support clinical effectiveness studies and financing models that integrate the new pharmacotherapies with psychosocial services in specialty addiction and primary medical care settings.
The great potential of immunotherapy will prove problematic if these new medications are incorrectly viewed as "magic bullets." The failure of these medications to meet expectations when used outside research settings could undermine their acceptance and the willingness of government agencies and private firms to finance the research needed to develop them. First, like any medications, these new therapies will not be completely effective for all patients. Second, some individuals may be unwilling to even accept the first dose if they fear making a commitment to sustained abstinence from their drug of addiction for a variety of reasons, including fear that they cannot easily reverse the medication or return to their drug use to relieve protracted withdrawal symptoms or for other needs. Third, for a variety of reasons, some patients will not remain in treatment but will relapse to smoking or drug use. Fourth, some individuals may refuse treatment because the therapies may leave long-lasting markers in their systems, thus subjecting them to possible adverse effects, such as denial for health insurance.
Fifth, some patients who receive these medications—even completely willingly—could behave in ways that would undermine their effectiveness, for example, by switching to drugs that are not targeted by the medication and by attempting to test or override the blocking effect of the medication by taking larger amounts of the drug. Moreover, the existence of what are seen as safe and effective treatments for addiction could make experimenting with drugs seem less risky and hence increase drug use. Conversely, if treatment programs using these new medications succeed in substantially reducing the number of existing addicts, dealers may aggressively attempt to interest new customer bases, as well as engage in violent "turf wars" to maintain profits in their existing markets.
Recommendation 6 The National Institute on Drug Abuse should support studies of behavioral consequences, such as the increased potential for accidental overdose and changes in drug use patterns, which may include switching drugs, increasing drug dosage or overall consumption, changing the route of administration (e.g. nasal to intravenous for greater bioavailability) or, conversely, avoiding use of other addictive substances.
Recommendation 7 The National Institute on Drug Abuse should support studies that examine the extent to which the availability of immunotherapy medications might reduce the perceived risk of drug use and the effects of such changes on drug use behavior in various populations.
Recommendation 8 The National Institute on Drug Abuse should support studies of the potential effect of immunotherapy medications on illicit drug markets and market-related behaviors.
Enthusiasm for the new medications should not obscure the fact that fully informed and voluntary consent is necessary under any and all circumstances. These medications can produce long-lasting biological markers (raising issues of confidentiality and potential for discrimination) and might interfere with drug-testing methods. The free and informed nature of consent is of special concern if the medications are used in settings and circumstances that are inherently coercive. These therapies may offer great benefit, even when used in such settings. However, any such benefit needs to be balanced against the rights to privacy and liberty that have long been recognized in the provision of medical care. Particular complications may arise in obtaining consent from persons in the criminal justice system, from pregnant women, from women who are already parents and involved with the child welfare system, and from adolescents and children whose parents or guardians seek to administer these medications for "protective" use.
Recommendation 9 The National Institute on Drug Abuse should support studies to determine the standards to be applied when immunotherapy medications are considered for use in the criminal justice and child welfare systems including due process protections when there is a government-imposed treatment requirement.
Recommendation 10 The National Institute on Drug Abuse should support studies to carefully articulate the behavioral, ethical, and social risks associated with treatment of pregnant women and their fetuses and protective therapy in minors and to develop clinical practice guidelines for such use or discouragement of such use.
The American Psychiatric Publishing Textbook of Substance Abuse Treatment edited by Marc Galanter, Herbert D. Kleber (American Psychiatric Association) This comprehensive third edition, like previous editions from 1994 and 1999, reflects the still-growing commitment of psychiatry to addressing the problem of substance abuse. Fully updated, this volume offers definitive depth and scope. The 94 distinguished contributors cover the latest basic and clinical perspectives on the nature of addiction, an overview of available treatments, treatment for specific drugs of abuse, treatment approaches, special approaches and treatment programs, and special populations.
Recent years have seen important advances in the addiction field, with increased understanding of receptor mechanisms, membrane chemistry, and patterns of genetic transmission. Public awareness has never been greater, and individuals seek help earlier, when more effective treatment can be administered. All of these factors have made recovery a possibility for most people who abuse substances.
Thoroughly indexed and generously illustrated, this new edition is designed for clinicians, researchers, and trainees in psychiatry, general medicine, and other health professions. This remarkable volume is the definitive resource for any health care professional concerned with the problems posed by substance abuse.
Substance abuse, a worldwide problems of major dimensions, was identified in a 2001 re-port to the Robert Wood Johnson Foundation as the number one health problem in the United States. The estimated annual U.S. economic cost of substance abuse is more than $414 billion. In the United States, 18% of the population experiences a substance use disorder at some point in life. Furthermore, an aver-age of 20% of patients in general medical facilities and 35% in general psychiatric units present with sub-stance use disorders—and in some settings, the percentage is much higher. Although the sequelae of ad-diction, such as cirrhosis, psychopathology, trauma, and infection, generally receive proper medical attention, patients' primary addictive problems often go untreated.
Nonetheless, we stand on the threshold of important opportunities in the addiction field. In recent years many advances have emerged in receptor mechanisms, membrane chemistry, and patterns of genetic transmission. Public awareness of the need for greater research and treatment resources has been aroused as well, and substance abusers now seek help earlier, at a point when treatment can be administered more effectively. Furthermore, the health community has been alerted to the need for early diagnosis and comprehensive care. New treatment concepts, both pharmacological and psychosocial, have made recovery a possibility for most alcohol- and drug-abusing patients.
The first edition of this volume emerged from a growing commitment of psychiatry to address the problem of substance abuse. In 1982, the American Psychiatric Association (APA) established its Task Force on Treatment of Psychiatric Disorders, consisting of 26 panels. The editors of this textbook served as chairpersons of the panels on psychoactive substance use disorders, alcohol, and other drugs. In response to this APA initiative, we brought together a group of experts who could provide a carefully drawn perspective on addiction treatment, perhaps the most comprehensive one to date. After several years' work, our panels developed reports for the Task Force that were published by the APA in 1989 in the four-volume set Treatments of Psychiatric Disorders.
Soon after the appearance of these volumes, we decided that it was important to update and amplify the substance abuse treatment information. In addition, we wanted to focus on the most recent developments in biological and psychosocial therapies and the problems of specific populations. The resulting volume, the first edition of this textbook, appeared in 1994, and the second edition followed in 1999. We are now pleased to present a fully updated version of this text-book, tailored to represent the most current basic and clinical perspectives on the substance abuse field.
Most important to the development of the current edition was the maturation of the substance abuse field itself. As recently as the mid-1980s, American departments of psychiatry, as well as academic programs for other health professionals, paid little heed to the importance of training for substance use treatment. Although the medical addiction community had been vocal over the previous two decades about the need for better care, investment in addiction training was relatively small and had only a limited association with academic teaching centers. This situation has changed dramatically in recent years. Substance abuse training is now an integral part of undergraduate curricula in most medical schools and is a one-month full-time equivalent component of psychiatry residency training programs. Courses about substance abuse are also regularly taught in graduate psychology and social work pro-grams. The federal institutes on drug and alcohol abuse are fully aware of the need for research training and are working closely with organizations in the addiction field to promote growth in clinical teaching as well.
The approval of the American Board of Psychiatry and Neurology for an Added Qualification in Addiction Psychiatry was of major importance in establishing addiction as a medical subspecialty. The American Board of Medical Specialties, under its guidelines for establishing subspecialties, sanctioned this process. The first certifying examination was given in 1993, and certification is now given by APBN on the basis of an examination and a minimum of one year of associated training in an accredited residency. The Accreditation Council for Graduate Medical Education reviews the curricula of these respective training programs, and completion of such a program is required by candi-dates to sit for the subspecialty examination. In 1996 the first PGY V and PGY V–VI addiction psychiatry residencies were approved, and certified programs are now listed in the Graduate Medical Education Directory.
As of this printing, more than 1,800 psychiatrists are certified in Addiction Psychiatry. These subspecialists will meet a variety of clinical and academic needs, and the range of training experiences provided by the addiction residency programs has been designed to prepare them for this. These residents spend about half their time on patient care and devote the rest of their time to research, teaching, and their own learning. Postresidency fellowships in addiction psychiatry now number more than 40. These programs are showing great vitality and are playing an influential role in ensuring quality treatment for the future. Unfortunately, less than half of the population in need of sub-stance abuse treatment actually receives it—a function both of the reluctance of private and public payors to adequately fund treatment and of the reluctance of the affected population to seek it.
We have designed this volume to serve clinicians in practice and researchers concerned with addiction as well as trainees in psychiatry, general medicine, and other health professions. We therefore hope that this book will serve as a valuable treatment resource for any health care professional concerned with the problems posed by the issue of substance abuse.
Chemical Dependency: A Systems Approach, Third Edition by C. Aaron McNeece, Diana M. DiNitto (Pearson Allyn & Bacon) Substance abusers affect everyone they come into contact with, and state and federal policies regarding substance control seem to change constantly. This book takes a comprehensive look at substance abuse from a systems perspective, which makes it particularly appropriate for social workers who are accustomed to a "person-in-environment" perspective. This book covers all the major theories of addiction, as well as the major psychological and physiological results of substance abuse, including fetal alcohol syndrome. Social workers, therapists, drug and alcohol counselors.
Excerpt: Our goal for this third edition of Chemical Dependency: A Systems Approach is to present a comprehensive, systems-oriented approach to addressing alcohol and other drug problems. In our combined experiences in various aspects of the chemical dependency field, which have spanned the last 30 years, we have heard many opinions on the causes of substance use disorders and the remedies to these problems, but often, there has been a lack of critical reflection and evidence to back those views. With that in mind, we have tried to ground this text in evidence. Granted, we have our own opinions on the state of affairs, but we and the other contributors to this volume have done our best to incorporate knowledge derived from research arid theory.
Like many others in the field, we are concerned that much of what goes on in treatment is not based on scientific evidence of effectiveness or efficacy. We are even more dismayed that the "drug war" (law enforcement and interdiction) continues unabated, despite the fact that there is no evidence that this approach has stopped a single individual from using drugs or encouraged anyone to pursue recovery. The supply of alcohol and other drugs in the United States is limited only by the user's economic means and ingenuity. The evidence does tell us, however, that some individuals do benefit from treatment, and we are committed to informing helping professionals—particularly social work students and others preparing for careers in the helping professions—about approaches that may help their clients avoid or address substance use disorders. We are as committed to addressing policy interventions as we are to individual and family interventions because we believe that interventions at all systems levels can be useful in preventing problems and encouraging recovery once a problem has developed. Every helping professional needs to be informed about at-risk drinking and substance use disorders, including how to identify these problems, how to intervene once they have been identified, and how to make referrals. Given the devastation that substance use disorders can bring, there is an ethical imperative to do so.
All too often, clients are described as rationalizing or minimizing their alcohol and drug problems, but clinicians, program administrators, and policymakers are just as likely to rationalize. Not only do these professionals often blame clients for not taking advantage of available services, but they also frequently fail to sufficiently consider the designs of
programs that might better attract clients to services and policies such as insurance cover-age that may encourage more people to seek services. We acknowledge that the study of substance use disorders is in its infancy and that many questions remain to be answered. Our hope is that this book will encourage people to keep up with the growing literature in the field and to give more serious consideration to how we can better address these pervasive problems.
Part One of this text addresses theories, models, and definitions of substance use disorders. Chapter 1 covers definitions and epidemiology and discusses the process of becoming addicted. We have added a new Chapter 2 that summarizes most of the current theories on the etiology of addiction. Chapter 3 addresses the biology of the brain and the plethora of theories about alcohol and other drug disorders. With the current emphasis on brain biology as an explanatory factor in alcohol and drug disorders, social service professionals need to know more about this topic. (The authors of this chapter have tried to make the chapter as user friendly as possible.) There is an amazing array of ideas about what causes abuse and dependence. Many people believe there is no single or simple cause, that multiple factors are implicated, and that the cause may vary from one person to the next. Chapter 4 describes the physiological and behavioral consequences of substance abuse, identifying the effects of a wide range of substances. It is important for all human service professionals to know about these common symptoms and conditions.
Part Two addresses intervention, broadly defined. Chapter 5 describes screening, diagnosis, assessment, and referral—important skills for most helping professionals. The chapter also considers confidentiality and other ethical issues in substance abuse treatment. The stages of change model and motivational interviewing, which have become increasingly common and well-recognized tools in the field, are also discussed in Chapter 5. Chapter 6 looks at the system or continuum of care for people with alcohol and drug problems and de-scribes a broad cross-section of the treatment approaches that are used, from detoxification to aftercare and maintenance of sobriety. We use the terms system and continuum advisedly because the system or continuum is often poorly organized and many individuals lack access to components of care. Chapter 6 also addresses controversial strategies such as moderation and other harm-reduction approaches, as well as the mainstays of chemical dependency treatment and treatment innovations. Twelve-Step and other self-help approaches are also discussed in this chapter. Chapter 7 presents prevention theories and describes current pro-grams designed to prevent abuse or dependency, sorting out the more effective from the less effective approaches. Chapter 8 takes a macro approach to intervention, dealing with public policies regarding the manufacture, distribution, and use of psychoactive substances, as well as the social, economic, and political consequences of chemical abuse and dependency. Drug-related crime also gets serious consideration in this chapter.
Part Three is devoted to substance use, abuse, and dependence among particular population groups. The subject of Chapter 9 is treating children and adolescents with alcohol and other drug problems; prevention and family-based models are two of the options dis-
cussed. The family systems perspective and chemical dependency is the topic of Chapter 10, which also considers the most prominent family therapy theories and models and their applicability to alcohol and drug treatment. Chapter 11 considers culture and ethnicity and its effects on abstention, substance use, and substance use disorders. Much of the chapter addresses chemical use and related problems among the major ethnic groups in the United States; the information necessary for developing culturally relevant prevention strategies and treatment services is provided as well. Sexual minorities and substance abuse is the subject of Chapter 12. This chapter has been completely revised for this edition with a focus on the use of gay affirmative practice, a strengths-based approach to assisting gay men, lesbians, and other sexual minorities. Chapter 13 covers substance use disorders and co-occurring disabilities, including mental illness, intellectual disabilities, and physical disabilities, among others. The literature on co-occurring mental illness and substance use disorders has grown rapidly, but there has been almost no research on the substance abuse problems of individuals who are blind or visually impaired or deaf or hard of hearing. Alcohol and drug use and related problems among the elderly, the topic of Chapter 14, is another area that is often overlooked or ignored. The information provided in this chapter will raise readers' awareness of these issues among the growing population of older adults. Chapter 15 examines gender, comparing the substance abuse problems of men and women and considering myths and stereotypes about women and substance use disorders. This chapter also provides information that women need to know to avoid sub-stance use disorders and information that service providers need to know to more effectively assist women.
Part Four, which is comprised of Chapter 16, covers important topics such as financing chemical dependency treatment and the effects of managed care on treatment. Chapter 16 also addresses the futility of the "drug war," and we believe that our objections to this unconscionable assault on American families are grounded in evidence. We conclude with a look at implications for the future of research, education, practice, and policy in the field of substance use disorders.
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