In early 1999 the National Institute on Drug Abuse (NIDA) set out to develop new methods for conducting drug abuse research in which comprehensive studies could be done on large numbers of subjects without the usual geographic, ethnic, socioeconomic, and cultural biases that interfere with most drug abuse studies. In little over a year, NIDA has not only worked out the methods, but also made a solid start on the network of professionals needed to test developing drug abuse treatments.

The goal of large, population-based drug research was central to NIDA’s mission of "using science as a vehicle to improve the quality of drug abuse treatment throughout the country." In order to provide the science-based tools for clinicians to improve treatment of drug abuse applicable across a wide range of variables, it was obvious that NIDA would have to put together a forum for developing and testing new methods of drug treatment. Overseeing the funding for more than 85 percent of the world’s drug abuse treatment research, NIDA had an awesome responsibility to make the most out of the resources it had available.

NIDA and its advisors in drug abuse treatment faced some unique characteristics that set the field of drug abuse treatment apart from other medical treatment research programs. NIDA Director Alan I. Leshner, Ph.D., explained that at least two differences are significant. First, in drug abuse treatment, only some researchers are physicians; others are nonphysician, trained professionals. But a large number of drug abuse treatment professionals have not been formally trained but instead have come up through the ranks.

Second, in medicine, both research and treatment professionals are accustomed to rapid change. "In drug abuse treatment," Leshner told Psychiatric News, "it’s hard to change. It’s almost as if treatment protocols are thought of as a religion."

Leshner explained that NIDA had to approach the subject of change as giving drug abuse treatment professionals additional science-based tools, not substitutes. "It’s like telling them," Leshner said, "to keep doing what they are doing, but here, try this also. If it works, you’ll add it to your toolbox."

In developing its Clinical Trials Network (CTN), NIDA sought to mirror the successful model used by other federal institutes, including the National Cancer Institute, National Heart, Lung and Blood Institute, and National Institute of Allergy and Infectious Diseases. It sought to develop a research infrastructure that would test whether new treatment protocols are effective in real-life settings with diverse patient populations. Developing a CTN was the primary recommendation of a 1998 Institute of Medicine report, "Bridging the Gap Between Research and Practice," which looked at ways to improve drug abuse treatment in the U.S.

The CTN, when complete, will consist of 20 to 30 regional research treatment centers (nicknamed "nodes"), each linked with 10 to 15 community-based treatment programs. The programs associated with each node must reflect the variety of treatment settings and patient populations found in that node’s geographic location. Each node participates in the overall program to conduct multisite clinical trials research.

The first node awards were announced in September 1999 (see above). Last month, NIDA closed the applications process for the second round of grants, with an additional five nodes to be funded in Fiscal 2001. The recipients of the five new node designations are expected to be announced by the end of September.

Betty Tai, Ph.D., director of the Clinical Trials Network at NIDA, told Psychiatric News that the first three protocols will start soon at the existing nodes. "A total of seven protocols is under development," Tai said. "Patient enrollment should start this summer."

The three trials will be six- to-eight-week studies involving concepts that will be as relatively simple to implement as the first trials. "These first trials will not only test very basic questions in drug abuse research," Leshner said, "but will also help us to learn how to work the new system."

Tai agreed. "We wanted to start with very basic concepts that we already know at least something about, because we have to figure out how to run the network at the same time."

Tai said that the three trials are: a study of motivational incentives for improved treatment outcomes, a study of motivational enhancement treatment to improve engagement and outcome, and a trial of buprenorphine and naloxone for opiate detoxification.

Leshner said that while the concept of a CTN is now accepted in the drug abuse treatment community, making it a productive, successful forum is another matter.

"People have bought the vision that we are going to improve drug treatment around the country, using science as the vehicle. Now, we just have to do it."