By Barbara Shine, NIDA NOTES Contributing Writer
In NIDA's Clinical Trials Network (CTN), researchers and practitioners collaborate in the design as well as the execution of drug abuse treatment studies. Continuous collaboration with treatment providers, a distinguishing feature of the network, ensures a research focus on practical questions that arise in typical patient populations and community treatment settings.
A new study begins when a researcher or treatment provider identifies a clinical need and formulates a solution or intervention to meet it. Research ideas are accepted only if they coincide with public health priorities and meet two standards— feasibility and sustainability. A feasible research concept is one that can be tested in established, community-based treatment programs with varied patient populations. To meet the sustainability standard, the proposed intervention should be possible to continue in community treatment programs equipped with a realistic complement of resources after study completion. The concept proposal also must stand on a foundation of previous supporting research. Once it meets these criteria and gains approval within CTN and by NIDA, the proposal is ready to move on to protocol development and final NIDA approval and funding.
An example of the pragmatic approach to research design is the recently completed CTN-sponsored study "Motivational Incentives for Enhanced Drug Abuse Recovery." This work is based on the general idea that rewards—including supportive words, praise, money, or desirable objects—for a particular behavior promote like behavior in the future. Two protocols emerged: one for implementation in methadone maintenance clinics and another for study in clinics using treatments other than methadone maintenance.
"There were two key points to negotiate in designing these trials," says Dr. Maxine Stitzer of Johns Hopkins University School of Medicine in Baltimore, the principal investigator for both motivational incentive protocols. "The first was selection of the drug target. Previous incentive studies had targeted only one drug, but we targeted both cocaine and methamphetamine to address regional differences in stimulant abuse. We added alcohol as a primary target and opiates and marijuana as secondary drug targets to emphasize the importance of giving up all drugs, not just the particular one that brought the patients into treatment. Patients could draw chances to win prizes when their breath and urine samples were negative for target drugs."
"The second big issue was how much the prizes should be worth," says Dr. Stitzer. "Early studies in research centers cost upwards of a thousand dollars per patient for prizes; community treatment providers made it clear they needed an effective motivational approach that would not exhaust their much smaller budgets. People in our study drew chances to win a range of prizes—from bus tokens, to $20 grocery vouchers, to compact disc players—that were more realistic for community treatment centers."
Members of the protocol development group benefited from meeting with Dr. Nancy Petry, an investigator who conducted similar studies at the University of Connecticut in Farmington, and with several of her clinical staff and patients. "We really gained valuable insights and heard firsthand how the patients' motivations changed over the course of their treatment, from working for prizes to working for their own good," says Dr. Stitzer.
Once NIDA approved the motivational incentives protocol, investigators implemented the study in 14 treatment programs with a total of about 800 patients. Preliminary analysis of the data suggests that the addition of reward systems to standard therapy will improve outcomes for drug abuse patients. Once Dr. Stitzer and her team analyze and publish the results, clinicians will know whether motivational incentives are truly an effective adjunct to current therapies.
For More Information...
To learn more about CTN protocols, including studies that are now recruiting patients, visit the NIDA Clinical Trials Network Web site, www.drugabuse.gov/CTN. Both English and Spanish brochures for patients and physicians are available for download, and the site lists contact information for all regional research and training centers and clinical trials.
Dr. Petry's research is highlighted in "Fishbowls and Candybars: Using Low-Cost Incentives To Increase Treatment Retention" (NIDA Science & Practice Perspectives, Vol. 2, No. 1, p. 55), which is also available on NIDA's Web site.
Volume 19, Number 4 (December 2004)