Behavioral research in drug abuse treatment is moving into what promises to be an exciting new era. The National Institute on Drug Abuse (NIDA) is creating a clinical trials network that will combine science, practice, and community-based programs in a wide-scale, long-standing infrastructure for developing and testing science-based approaches to treating drug abuse and addiction.
The network will consist of regional “nodes,” which have been likened in structure to snowflakes. That’s especially significant because like snowflakes, no two will be completely alike. But there will be some core elements: Each nodes will link a research and training center with numerous community based treatment programs that will collaborate with one another and with NIDA and will take promising new treatments that have been successfully demonstrated in narrower circumstances and test them in a variety of geographics, organizational, and community settings with diverse patient populations.
In announcing this initiative, NIDA officials indicate that they are capitalizing on the nation’s highly productive drug abuse research enterprise, which has been particularly successful in developing behavioral interventions for drug abuse.
“The development of this critically needed research infrastructure will have an incredible impact on the way drug abuse treatment is delivered in this country,” predicts Alan I. Leshner, APS Charter Fellow and director of NIDA. “We have a large array of behavioral treatments currently available and ready to be tested in real life settings, and we anticipate that additional treatment that combine pharmacological and behavioral approaches will be available in the near future,” he said.
“With this initiative, NIDA will be taking a major step forward in developing and testing effective science-based drug abuse treatments,” said Leshner.
Another goal of the drug abuse clinical trials network is to produce better methods for transferring knowledge about new interventions into the treatment arena, a.k.a. the real world. But, NIDA is emphasizing, rather than replacing existing treatment approaches, the network will focus on validating and adding to those approaches.
Competition is just getting underway for the first year of funding. NIDA expects to fund up to four nodes in the first year, with an expanded number each year thereafter until the network reaches 20-30 nodes.
Examples of the types of behavioral studies that will be supported include:
- Testing behavioral therapies in community settings with different patient populations
- Developing techniques for transporting new behavioral therapies into community-based treatment programs
- Examinations of the impact of drug addiction treatment and AIDS risk reduction counseling on HIV risk behaviors in addicts
- Behavioral interventions aimed at improving compliance with medication regimens in patients with comorbid addictive and mental or physical disorders
- Development of models for integrating new behavioral interventions into existing clinical practices
- Research on ways to facilitate risk reduction for the intertwined epidemics of addiction and AIDS
One of the biggest unknowns facing the clinical trials network in this initial phase is how to ensure collaboration between research centers and community programs, two sectors that in the past have not always had strong ties. But the participation of the community-based treatment programs is viewed as essential to the success of the network.
“It is critical that the community-based treatment providers understand that they will be full partners with the research centers in all aspects of the protocol design and implementation,” said Timothy P. Condon, Associate Director of NIDA. “This is one of the key elements for ensuring the success of testing new approaches in real-life settings,” he said.
The importance of this partnership is underscored in the Request for Applications (RFA) for the network, which says that “through this joint effort, the gaps in current treatment approaches will be addressed, yielding community-proven treatments ready for adoption in clinical practice.” (The complete text of the RFA is available at www.nih.gov/grants/guide/rfa-files/RFA-DA-99-004/html.)
There is a great deal of support for the development of this clinical trials network in the drug abuse treatment field generally. In addition, the Institute of Medicine and the National Academy of Sciences recently issued a joint report, Bridging the Gap Between Research and Practice, that identified this kind of network as the single mechanism most likely to improve drug abuse treatment in this country. This model has been used successfully by other institutes at the National Institutes of Health in the areas of cancer, heart disease, and infectious diseases.
Critical deadlines for NIDA clinical trials network applications are March 13 for a letter of intent, and April 13 for the application receipt. For further information, interested parties are urged to contact Jack Blaine, chief of the treatment research branch, at 301-443-2397.