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National Institute on Drug Abuse - NIDA NOTES
Volume 16, Number 6 (February 2002)

NIDA's Clinical Trials Network Marks Progress Toward Improved Drug Abuse Treatment

By Robert Mathias, NIDA NOTES Staff Writer

More than 300 members of NIDA's National Drug Abuse Treatment Clinical Trials Network (CTN) met in September to celebrate 2 years of progress toward building a nationwide network of researchers and practitioners to conduct clinical trials of promising drug abuse treatments in community settings. The meeting in Crystal City, Virginia, updated participants on the growth of the network, ongoing clinical trials, and upcoming protocols in which they may participate. The meeting also spurred discussion of organizational challenges and other issues that must be addressed to continue to generate clinically useful information from future trials.

"From its inception, the CTN has been marked by an ongoing dialog between researchers and practitioners that has played an integral role in the remarkable growth and evolution of the network," then-NIDA Director Dr. Alan I. Leshner said in a message to meeting participants. "The resulting development of a true working partnership between researchers and practitioners accounts for the extraordinary advances we have made thus far and holds great promise for achieving our mutual goal of making science the foundation for improved drug abuse treatment throughout the Nation."

Among the CTN's accomplishments cited by Dr. Leshner and Dr. Betty Tai, who directs NIDA's CTN Office, are the following:

  • The CTN has expanded to 14 regional research and training nodes with 91 affiliated community treatment programs (CTPs) and more than 500 treatment sites.

  • Six treatment research protocols with a projected total enrollment of more than 2,600 patients are underway at 52 sites; more than 530 patients have been screened for the trials and 373 have been randomly assigned to receive either an experimental treatment intervention or standard treatment. (See "NIDA Clinical Trials Network Begins First Multisite Tests of New Science-Based Drug Abuse Treatments.")

  • Six additional treatment research protocols are in the final stages of development and will soon be implemented in CTPs.

  • A third wave of new research concepts has been approved and is moving toward protocol development. (See "The CTN's First Three Waves of Research Protocols.")

  • Six special interest groups have been formed to focus research plans to address drug abuse treatment issues related to special populations and coexisting conditions, such as HIV/AIDS. (See "Special Interest Groups Focus CTN's Research.")

Participants Share Research And Practice Experiences

In a panel presentation, research and practice partners from CTN nodes that pioneered the implementation of the first wave of treatment research protocols discussed issues they confronted in conducting clinical trials in diverse community settings.

"The commitment to research of everyone in the CTP is critical to successful implementation."

CTPs must address staff attitudes before, during, and after initiation of research protocols, several panelists noted. "The commitment to research of everyone in the CTP is critical to successful implementation," noted Dr. Greg Brigham, principal investigator at Maryhaven, Inc., a CTP in Columbus, Ohio, that is part of the Ohio Valley Node. Offering multiple staff training opportunities, keeping key personnel informed about the status of their suggestions and concepts chosen for protocols, and providing feedback on challenges involved in implementing ideas can all enhance staff "buy-in," he said. Frequent conference calls between researchers and clinical staff and providing immediate access to information when it is needed also can help ease research into the clinic.

Conducting research in the CTP placed heavy demands on staff time and clinic resources, such as space, that exceeded their expectations, several CTP representatives cautioned. Because CTN reimbursement does not fully justify the amount of time spent on the protocol, CTP personnel must have other reasons for participating in the CTN, Dr. Brigham said. Dedication to advancing drug abuse treatment, the opportunity to collaborate with the best researchers and practitioners in the field, and recognition by State funding agencies that they are among the leaders in the drug abuse treatment field are some of the bonuses that can encourage CTP participation, he said.

Other panelists discussed additional potential benefits of participating in research. Treatment staff members cited the opportunity to enhance their professional abilities and credentials as substance abuse counselors. CTP administrators noted the potential for generating credible data on effective treatments that could buttress budget negotiations with State funding agencies. For all participants, the realization that their participation could help them to better serve their clients, including the most difficult-to-treat patients, argued for expending the considerable extra effort required.

"Conducting one of these protocols requires a tremendous amount of work and sensitivity on the part of both researchers and practitioners to address practical matters, ethical considerations, and enormous documentation requirements," said Dr. Leslie Amass of Friends Research Institute, Inc., and the UCLA Integrated Substance Abuse Programs in Los Angeles, which is part of the Pacific Region Node.

"Working with a diverse group of CTPs, ranging from drug-free clinics to hospital-based programs that are carrying out the buprenorphine/naloxone opiate detoxification treatment protocols, has been extremely rewarding for researchers because of the cooperation we are getting. We have more work to do, but we are seeing patients get better and the gap between research and practice is being bridged," she concluded.

NIDA NOTES - Volume 16, Number 6

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