Many behavioral and pharmacologic treatments for which there is strong empirical support are rarely used in clinical practice in the treatment of substance dependence. In an effort to facilitate greater emphasis on issues such as utility, practicality, and cost earlier in the evaluation of promising therapies, the authors propose a hybrid model to link efficacy and effectiveness research. A hybrid model may foster broader use of empirically validated treatments in substance abuse treatment programs and enhance the scientific yield of effectiveness research. The hybrid model retains essential features of efficacy research (randomization, use of control conditions, independent assessment of outcome, and monitoring of treatment delivery) while expanding the research questions to also address issues of importance in effectiveness studies. Such issues include diversity in settings, clinicians, and patients; cost-effectiveness of treatment; training issues; and patient and clinician satisfaction.A major issue facing virtually all areas of clinical psychiatry is the gap between research and practice and the associated call for clinical research to place a greater emphasis on effectiveness research and the evaluation of clinical utility of treatments (1-3). Disparities between research and practice are particularly apparent in drug abuse treatment (4). For example, despite overwhelming empirical support for the efficacy and cost-effectiveness of methadone maintenance (5-7), access to this form of treatment remains highly restricted in many areas of the United States (8-10). In locations in which methadone maintenance is available, this treatment is often administered in inadequate doses or with insufficient counseling and ancillary services, both of which make it much less effective (11,12). Similarly, behavioral treatments for which there is strong empirical support have rarely been implemented in clinical settings (13,14). Conversely, many treatments are widely used in clinical practice that have not undergone any evaluation of efficacy-for example, 12-step methods and auricular acupuncture (15,16).
Need for new research strategiesA recent landmark report by the Institute of Medicine (4) called for a greater emphasis on effectiveness research as a strategy for bridging the gap between research and practice. However, although methods and strategies for efficacy evaluation through randomized controlled trials have been well defined for both behavioral and pharmacologic therapies (17-19), the nature of what constitutes sound effectiveness research is much less clear. Traditional strategies-for example, large-scale demonstration projects-have too frequently had a negligible impact on the clinical community, policy makers, or third-party payers. This lack of impact may be due to several factors, such as failure to target critical questions about the treatment's utility in standard clinical practice, to methodologic flaws NIH Public Access To illustrate the need to address practice-related issues in efficacy researc...