Research focusing on the treatment of nicotine addiction seeks to identify, test, and effectively disseminate interventions to treat tobacco users who are addicted to nicotine. INTRODUCTION Most people who use tobacco regularly are addicted to nicotine. In recent years, a wide variety of approaches to treating nicotine dependence have been developed, including pharmacological treatments, behavioral therapies, and advice from health care providers. Though these approaches have enabled many cigarette users to stop smoking, modest success rates and substantial relapse have limited their effectiveness. As a result, broadly effective treatments that meet the needs of the majority of current tobacco users who are dependent on nicotine continue to be elusive. However, new developments have created opportunities for increased success in treating nicotine dependence. While these developments portend an increase in both the effectiveness and availability of nicotine addiction treatments, we still must answer many difficult questions to fully seize these opportunities to reduce tobacco use in the United States. For example, as new pharmaceutical products, including over-the-counter medications, are developed to treat nicotine addiction, we need to evaluate and maximize their effectiveness. We also need to learn whether harm-reduction strategies, which involve less exposure to nicotine and tobacco toxins, are an acceptable treatment alternative to abstinence and, if so, for whom these approaches are most appropriate. In addition, we need research to determine whether combination therapies, such as using two or more medications or combining behavioral therapies with pharmacologic treatment, are more effective than single-focus therapies. Finally, we must identify which subgroups of smokers are most and least likely to benefit from each approach. Developments in the Treatment of Nicotine Addiction Recent data suggest that the great majority of tobacco users--as many as 80 percent--would like to stop smoking. Treatment research could have a substantial impact on the Nation's public health by developing broadly effective and widely available therapeutic approaches to nicotine addiction. Increasing realization that adolescent tobacco users also need help in quitting has resulted in a number of clinical trials aimed at addressing treatment needs, methods, and services for this previously underserved group. Nicotine replacement products, such as nicotine gum and transdermal patches, can now be obtained over-the-counter. This may increase the success rate of the majority of tobacco users who prefer trying to quit on their own without the aid of a formal smoking cessation group or medical attention. Advances in genetics have begun to suggest how new treatments for nicotine dependence may be developed and targeted to those smokers who are most likely to benefit from them. Development of new medications, such as the nicotine aerosol spray, and the application of existing medications, such as the antidepressant bupropion, to the treatment of nicotine dependence, will widen the array of treatment choices available to nicotine-addicted patients and their health care providers. The Smoking Cessation Clinical Practice Guideline issued by the Agency for Health Care Policy and Research in 1996 has provided an effective, evidence-based treatment guideline that can be used by a variety of health care providers in a range of treatment settings. These questions can be answered by an organized, carefully planned program of research. Such a program interacts with other areas of tobacco research described in this report. For example, surveillance and epidemiology provide the up-to-date data on tobacco use behaviors needed to identify target groups and patient pools for treatment research. Biobehavioral and basic biological research provide information about psychosocial factors and genetic predispositions to nicotine addiction and tobacco-related cancers. They lay the groundwork for new treatments aimed at these factors. And, community and policy research help treatment research to increase access to treatment and widen dissemination of effective treatments. In addition, collaborative opportunities with pharmaceutical companies, NIDA, the National Heart, Lung, and Blood Institute (NHLBI), and other research institutes would be particularly appropriate in this area. RECOMMENDATIONS Research should be conducted concerning the treatment of nicotine addiction to find the best ways to tailor tobacco cessation interventions to specific sociocultural, psychological, physiological, and genetic subgroups. Tobacco use either has declined at slower rates, remained level, or increased among a number of subgroups within the overall population, such as women, blue collar workers, low-income Americans, ethnic and racial minorities, and adolescents. These trends indicate that tobacco-induced cancers and other serious health problems will continue to increase unless we conduct research to evaluate whether unique treatments are needed for special populations. Such research can tell whether treatments need to be tailored for groups, such as pregnant smokers, smokers with comorbid mental disorders, African-American tobacco users, cigar smokers, and adolescent tobacco users, or whether generic treatment approaches are just as effective. Also, as addressed in the Basic Biobehavioral Research section, advances in genetics and pharmacology may make it possible to determine whether a smoker's genetic makeup can be used to predict response to various treatments for nicotine addiction. Answering this question would make it possible to match treatment to an individual's genetic makeup to increase its effectiveness. Research should be conducted to determine the optimal settings and mechanisms to deliver effective tobacco cessation treatments to culturally diverse and high-risk populations. The development of tailored therapies for culturally diverse and high-risk groups is only the first step in reducing tobacco use and nicotine addiction among these populations. It is equally important to ensure that these treatments make the transition from research laboratories to successful application in the community. This creates an urgent need for treatment research in conjunction with community and state intervention research and policy research to learn how best to deliver and implement effective treatments and to ensure that tobacco users from traditionally underserved populations have access to them. These wide-ranging questions should be addressed on a number of levels, including:   managed care organizations (MCOs);   the growing array of new communications technologies;   training of health care providers; and   strategies centered on the worksite and health care settings ranging from primary to rehabilitative care. Innovative uses of the new digital media, for example, can be used to tailor smoking cessation programs based on information needs and preferences. Given limited health care resources, it is important to evaluate the relative cost-effectiveness of new and existing nicotine dependence treatments, as well as the effect of reimbursement policies on treatment delivery and utilization. OTHER RECOMMENDATIONS Research also is needed to assess the benefits and consequences of treatments designed to reduce harm from tobacco use. Such research should determine if approaches aimed at reducing exposure to nicotine and tobacco toxins, such as long-term nicotine maintenance through pharmacologic aids, are an acceptable alternative to abstinence for treatment-resistant tobacco users who are unable to quit. THE IMPACT OF TREATMENT RESEARCH The potential impact of improving delivery of existing treatments for nicotine dependence and developing new ones is enormous. With over 450,000 total deaths and 170,000 cancer deaths annually in the United States alone, the potential to reduce tobacco-related deaths and disease may be greater for nicotine addiction treatment than for any single medical treatment on the horizon. By improving our ability to understand nicotine addiction, developing better methods of treating it, and ensuring that those treatments are made widely available to all who wish to use them, including culturally diverse and high-risk groups, the treatment process can be made more effective and the toll of tobacco on our society can be significantly reduced.