Clinical Trials Network

In an effort to find the most effective treatments for drug addiction, the National Institute on Drug Abuse (NIDA) has established a clinical trials research network to test new pharmacological and behavioral treatments in diverse patient populations. Clinical trials have been used for diseases such as cancer and AIDS as a fast, effective, and safe way to test new treatments. Also, as with other diseases, there are a number of effective treatments for addiction. However, the efficacy of these new treatments has been demonstrated primarily in specialized treatment research settings, with somewhat restricted patient populations. As a consequence, few of these new drug-abuse treatments are being applied on a wide-scale basis in real-life practice settings

In response, NIDA has established the National Drug Abuse Treatment Clinical Trials Network (CTN). The CTN is based on a model used successfully by other NIH institutes, including the National Cancer Institute, the National Heart Lung and Blood Institute, and the National Institute of Allergy and Infectious Diseases. The CTN provides a research infrastructure to test whether new and improved treatment components are effective in real-life settings with diverse patient populations.

THE CTN STRUCTURE

NIDA has established the first six nodes of the CTN in various regions of the country. Each node or functional unit of the CTN is affiliated with a research-based organization and a number of drug-abuse treatment programs in the community. The CTN brings together researchers and practitioners as partners to conduct full-scale testing of promising new medications and behavioral treatments in a wide range of community drug-abuse treatment settings with patients from a variety of ethnic and social back-grounds. (The nodes to date include nodes in New England, the Delaware Valley, the Mid-Atlantic, the Northwest, the Pacific region, and New York.) Each of these centers is linked with at least five community treatment programs in its region. CTN research is carried out in the community-based treatment setting. Each node works with the other nodes and with NIDA to conduct multisite and cross-regional clinical trials research.

THE MISSION OF THE CTN

The overall goal of the CTN is to improve the quality of drug-abuse and addiction treatment throughout the nation using science as the vehicle. Toward this end, the mission of the CTN is threefold:

  1. Conduct studies of behavioral, pharmacological, and integrated behavioral and pharmacological treatment interventions in multisite clinical trials to determine effectiveness across a broad range of community-based treatment settings and diversified patient populations.
  2. Transfer the research results to physicians, providers, and their patients to improve the quality of drug abuse treatment throughout the country using science as the vehicle.
  3. Provide advice on changing policies to ensure the delivery of effective therapies in community-based treatment programs.

CURRENT AND FUTURE DIRECTIONS

Three science-based treatment research protocols will start in 2000, including two behavioral therapies developed to enhance treatment outcomes, and one that will test a new medication for use in opiate detoxification. Several other protocols are currently being developed. All treatment components to be tested have been shown to be effective in controlled research environments.

When complete, it is expected that the network will consist of twenty to thirty nodes consisting of regional research treatment centers linked to ten to fifteen community-based treatment programs that represent the variety of settings and patient populations prevalent in that particular region of the country. The CTN will help ensure that treatment research in drug abuse and addiction meets the needs of the wider community, including minorities, women, children, adolescents, and underserved populations. The CTN will also be useful to other aspects of NIDA's research portfolio. For example, multi-site clinical trials with diverse patient populations will provide a valuable resource to researchers interested in elucidating genetic and environmental determinants of vulnerability. Ultimately, increased understanding of the roles played by genetics, environment, and their interaction in shaping an individual's susceptibility to drug addiction will lead to a variety of more targeted drug abuse prevention and treatment approaches. For more information, visit NIDA's website at www.nida.nih.gov.

For more information about NIDA's National Drug Abuse Treatment Clinical Trials Network, visit the NIDA website at www.drugabuse.gov.

ALAN I. LESHNER