Cover Story

Clearly, researchers can learn much from testing their ideas in real-world settings. And so, too, can researchers benefit from clinicians' reports of what works in their practices.

With that outlook, the National Institute on Drug Abuse (NIDA) built a bridge between research and practice by establishing the Clinical Trials Network (CTN) in October 1999. The program partners 14 regional research centers, or nodes, with 85 community treatment programs nationwide to test research-based approaches to drug abuse in real-world clinical settings.

Psychologists and other health professionals nationwide submitted protocols for drug abuse treatment studies to the CTN Steering Committee, which chose seven initial protocols using three criteria: scientific evidence of efficacy, ease of implementation and potential to improve public health.

The network recently began treating 3,000 drug abusers with three protocols--tests of both pharmacological and cognitive treatments.

CTN's goal, says director Betty Tai, PhD, is to allow "science-based treatments to be readily transferred into practice in community-based treatment programs," thereby rendering them the new standards for drug abuse treatment.

Testing medications and behavioral treatments

"The first waves," as CTN participants refer to the three primary protocols launched about a year ago, are considering the outcomes of motivational incentive therapy, motivational interviewing and buprenorphine detoxification on drug abusers.

"We have planned protocols, trained counselors and now we are ready to see if we can help reach and retain patients," says Maxine Stitzer, PhD, a CTN investigator from Johns Hopkins University.

The major pharmacological study under way will compare how a new combination medication, buprenorphine/ naloxone (BUP/NX), detoxifies opiate addicts in comparison to the traditional medicine, clonidine. This investigation will bear weighty fruit indeed, as BUP/ NX is in the final stages of FDA approval.

"Results from the CTN study will certainly influence any decisions they make on using the medication in regular patient care," says Dennis McCarty, PhD, of Oregon Public Health Sciences University and co-principal investigator for the Northwest node.

This trial may also expand the scope of treatment in both inpatient and outpatient settings, as "buprenorphine is a partial opiate agonist," he explains, "and may be an appropriate alternative to methadone for some patients."

The CTN protocols are also studying behavioral drug abuse treatment, which increasing numbers of researchers and clinicians laud as the most realistic and effective approach to drug abuse treatment.

Hopkins's Stitzer is lead investigator for one such study, and values the fact that the CTN provides a forum in which psychologists can test such behavioral, in addition to pharmacological, interventions. For 20 years, she has tried to answer the question that drives her: How do drugs affect people, and how can we help those who are dependent conquer the difficult challenge of quitting?

Research may not yet have produced a definitive answer, but Stitzer nevertheless realizes that "drug abuse is fundamentally a behavioral disorder that needs to be tackled as such."

Her protocol tests Motivational Incentive (MI) therapy, which provides patients with concrete rewards for abstinence. In the clinic, patients can draw for prizes when urine tests indicate no drug use, a method that "counteracts the powerful reinforcement that drugs hold by offering tangible and immediate incentive for not using them," says Stitzer.

The CTN's five methadone-treatment and six drug-free clinics participating in the trial are expected to garner 800 patients. Each will be outfitted with $400 in goods and services--from grocery vouchers to tennis shoes--prizes that reward staying clean and support a positive lifestyle.

Stitzer is confident the outcomes will be positive. "Incentives have worked very well in research clinics," she says. "But the point of the CTN is to see if any factors in community clinics will impede or enhance the effects of these interventions."

The evolution from theory to practice within the clinical setting also intrigues Yale University's Kathleen Carroll, PhD, principal investigator for CTN's Southern New England node. Carroll leads another behavioral study, which gauges the effects of integrating Motivational Enhancement Therapy (MET) into the initial sessions of standard drug abuse treatment.

"Through impassive listening to patients," Carroll explains, "one encourages them to begin processes of change." The clinician may, for example, ask open-ended questions to prompt reflection on the physical and psychological hazards of drug abuse. Under the auspices of the CTN, explains Carroll, "we can find out whether MET works in real-world clinical settings, on diverse populations of patients."

Another protocol is assessing the efficacy of a therapist's delivery of MET in three separate therapy sessions during the first three weeks of treatment. In all, 1,100 patients from 11 community-based programs from across the nation are expected to participate.

Clinical trials and error

The union of investigators and clinicians working together to implement innovation is a major event, Carroll says. "Moving behavioral and pharmacotherapy into the real world is a remarkable way to bridge the gap between research and practice."

As the CTN only recently began its three initial protocols, no definitive conclusions on them can yet be drawn.

"Clinical trials will be difficult for most treatment programs to implement," admits McCarty, "and investigators and practitioners need to negotiate new relationships and learn each others' communication styles and language."

Even so, the CTN has already been a wonderful learning experience, Stitzer says. "Researchers get to know the needs of clinicians out in the trenches and clinicians learn about new treatments."

McCarty already affirms that when researchers involve clinicians in the design, implementation, analysis and interpretation of research, "they are more responsive to the findings." The result, he says, is "improvements not only in practice, but in research."