From the laboratory to rehab hospitals to the streets: that's where proven research models of treating drug abuse are traveling.

Neuroscientific and behavioral research initiated and commissioned by the National Institute on Drug Abuse (NIDA) has uncovered convincing evidence that drug addiction is a chronic and, for some, recurring disease. Treatments developed because of this addiction disease model have been found effective, at least in specialized treatment settings with restricted patient populations. But will these promising results hold up where people live — from rural communities to the suburbs to urban streets?

The purpose behind NIDA's Clinical Trials Network (CTN) is to "provide a research infrastructure to test whether new and improved treatment components are effective in real-life settings with diverse patient populations," i.e., at the community drug treatment centers level.

"The Clinical Trials Network is the single mechanism most likely to improve drug abuse treatment in this country," Alan I. Leshner, Ph.D., the director of NIDA, said.

"Our over-arching goal is to improve the quality of drug abuse treatment throughout the nation, using science as the vehicle. By expanding the Clinical Trials Network we will shorten the time it takes to bring the findings of laboratory research about addiction to useful implementation in real-life community treatment settings."

NIDA has been "exploring the biomedical and behavioral foundations of drug abuse for twenty years, but this is the first time the research laboratory and the real world have been so thoroughly integrated" to determine how well pharmacological and behavioral therapies work in treating addicts, according to Leshner.

The CTN was launched in January 1999 with a call for grant applications, and is modeled on successful clinical trial designs used to develop and test treatment for heart disease, stroke and cancer. This is the first time the CTN model has been applied to the treatment of addictions, however.

On October 1, 1999, the Clinical Trials Network Unit was established within NIDA, with Betty Tai, PhD., as director. "The CTN resulted from the 1998 Institute of Medicine report, Bridging the Gap Between Research and Practice, about drug abuse treatment," Tai told Counselor. "That study recommended that NIDA follow the CTN model, bringing practitioners and researchers together. Nine months later, the first of six grants was awarded; now there have been eleven grants in one year.

"The national meeting in Los Angeles [October 30 through November 2, 2000] marked the first anniversary and the beginning of bringing the universities and the subcontractors, local drug-abuse treatment centers, together. Now local community treatment centers can coordinate with university researchers to document the effectiveness of a variety of pharmacotherapies and behavioral theories.

"There are seven ongoing protocols, which are starting to enroll people now," Tai added. "There is a very special criteria: these protocols have proven effective in research settings, now we need to take into consideration real-life settings, to see if they are effective there as well and, if so, how to implement them in the real world."

To coordinate this effort on a nationwide scale, NIDA is awarding grants — "a total of $11 million over five years" for the first five centers, Leshner said.

Eventually NIDA's CTN will receive $121 million total funding over five years, NIDA reported. The grants have been awarded to universities in eleven regional centers so far, called nodes. Each university will then link up with at least five community drug treatment programs (CTPs) in their area, providing the research infrastructure for the CTPs. The CTPs in turn provide the clinicians and the patient population.

• Delaware Valley Node: University of Pennsylvania
• Florida Node: University of Miami, Coral Gables
• Great Lakes Regional Node: Wayne State University, Detroit
• Mid-Atlantic Node: Johns Hopkins University, Baltimore, and the Medical College of Virginia, Richmond
• New England Node: Yale University
• New York Node: New York University/New York Veterans Administration Medical Center, New York
• Northwest Node: Oregon Health Sciences University, Behavior Health Sciences, Portland
• Ohio Valley Node: University of Cincinnati, Cincinnati
• Pacific Node: University of California at Los Angeles
• Rocky Mountain Node: University of Colorado Health Sciences Center, Denver
• Southeastern Node: Medical University of South Carolina, Charleston

Beyond these studies, "We would hope to have more," Tai said, "but we are limited by funding. But, as the program continues and hopefully proves effective, we would hope to get support from the public and other funding sources. Every patient deserves the opportunity to participate in the most effective substance abuse treatment available."

"Each protocol targets a different population of drug abusers," explained Tai. "For example, there is one for opioid patients in particular. Some of the behavioral protocols allow for a wider inclusion of patients."

Other specialized target patient populations include women, African Americans and adolescents (Southeastern Node); injecting drug users at high risk of HIV (Rocky Mountain); drug abusers in rural Appalachia (Ohio Valley); a "therapeutic community for the indigent, many of whom also have mental disorders" (Great Lakes); and adolescent and family treatment, treatment for HIV/AIDS and mobile counseling units (Florida).

"That's the beauty of the CTN, that we can take research targeted to a highly specific population's treatment needs, and use it to benefit and research a highly diverse patient population outside of the laboratory," Tai said. "We also hope to target traditionally underserved populations, including adolescents and minorities, and rural populations, such as those in Appalachia."

The control population of the CTN are those who are already in community treatment programs. "We're not telling them to stop, but having them continue treatment as usual," Tai said, "so they can function as the control group."

The CTN is only studying drug abusers, not alcohol abusers, according to Tai, since the latter population is under the auspices of the National Institute of Alcohol Abuse only.

"However, in real-life settings," Tai noted, "we recognize that drug and alcohol abusers are generally not separable. Very few patients abuse only one substance. Although we will take alcoholics into the studies, it is only to target their drug abuse problems."

The Betty Ford Center in Rancho Mirage, California, is one of the centers working with UCLA in the Pacific Node. Specifically, they're testing buprenorphine for heroin addicts. "Buprenorphine, taken orally or in a dermal patch form, relieves some of the withdrawal symptoms associated with opiates," explains Nancy Waite-O'Brien, PhD, director of psychological services and professional development at the center.

"It helps with pain, alleviates nausea, and it's being compared with clonidine for inpatients onsite at the Betty Ford Center for fourteen days."

In the Mid-Atlantic Node of the CTN, Johns Hopkins University in Baltimore and the Medical College of Virginia at Virginia Commonwealth University (MCVCU) in Richmond are also studying buprenorphine among its three major areas of research, as well as behavioral interventions involving motivational incentives and interviewing follow-ups with patients.

"None has been launched yet, but by January 2001 some studies will be up and running. Not all studies are appropriate for all community treatment programs or clinics," according to Janet Knisely, PhD, co-principal investigator at VCU and part of the Department of Psychiatry and Internal Medicine at MCVCU, in the division of addiction medicine.

"As part of the CTN, VCU provides the research staff while the community treatment programs provide the clinical staff," Knisely said. "The Mid-Atlantic Node includes two Virginia sites, one in Washington, D.C., and eight or nine Maryland sites. The idea is to get people in the various agencies to participate, and the goal is to build upon the successful investigations and interventions. If, for example, we find that any of these protocols doubles the retention rate, we're going to be continuing services. Hopefully the investigations will prove efficacious, in which case we'd leave the programs at the CTPs.

"Right now there are eleven nodes," added Knisely.

"NIDA's goal is to have more than 100 of these nodes going, with most lasting for about a year at least."

Other research being conducted across the U.S. includes studies of cocaine, heroin and methamphetamine addictions, and combinations of them.

In some studies, drugs such as buprenorphine are being tested as alternatives to methadone, or to ease withdrawal symptoms, or to reduce cocaine use. In others, "motivation incentives," contingency management or follow-up phone calls are part of the protocol, to see if a personal touch after inpatient treatment — calling regularly to see how the recovering addict is doing — helps people stay sober.

At one of the centers associated with Johns Hopkins, they're studying the usefulness of vouchers to reinforce abstinence from cocaine and other drugs at drug-free and methadone clinics. Newer protocols being developed include screening for hepatitis C as part of the CTN in New York City.

An offshoot of UCLA's association with the Betty Ford Center is the protocol whereby patients who have completed treatment for drug abuse are called back at regular intervals. Waite-O'Brien explains that every seventh patient who is discharged is marked for this program, and called at first twice a week, then less often for as long as a year. This pilot project has shown promise in keeping in touch with patients — and in helping patients keep clean.

Researchers at Oregon Health Sciences University are initiating two protocols under the leadership of Dennis McCarty, PhD, a professor in the department of public health and preventive medicine in Portland, Oregon. One protocol again involves buprenorphine in opiate detoxification in outpatient settings, while the other is a study of "motivational interviewing," he told Counselor.

"This technique is built in to the intake and assessment process of drug abuse patients and is an attempt to see if we can increase the rate of retention and care in the program. The motivational interviewing techniques are used to help patients and is an attempt to see if we can increase the rate of retention and care in the program. The motivational interviewing techniques are used to help patients identify the impact that drugs are having on their lives, to stimulate them to enter into treatment and stay there, thereby reducing the attrition that occurs early in care. The biggest challenge is often getting patients to come back for a second session."

One of the unique features of the Northwest node, he added is that OHSU is working with community treatment centers across the state.

"Doing the research in different programs, where each will naturally do things a little differently and have a different population, gives us a fairly high degree of confidence that the protocol is effective," McCarty said. "In each case, the 'control' or, more accurately, the comparison group are the patients who are receiving treatment as usual.

"The CTN is designed to demonstrate not only the efficacy in academic research of a particular treatment, but also the effectiveness of that treatment in the chaos of regular community treatment programs." This also accounts for the overlapping or repetitive nature of some protocols in nodes across the country, with their different patient populations.

A principal investigator (PI) at the university leads each protocol. The PI proposes the protocols and then heads up the team, which designs and then implements the studies in conjunction with community drug treatment programs.

All of the PIs make up the CTN steering committee, which meets with NIDA. NIDA poses any concerns it may have and, if the protocol is accepted by the steering committee, the PIs are charged with organizing the project and making it happen at the university and local levels.

Each of the current eleven universities will work with at least five community drug programs, for a connection with about sixty CTPs. They hope to recruit about 75 patients a year from each treatment program, with approximately 4,500 patients participating in the drug abuse protocols when they are operational.

Each step of the way everyone is an active participant in the whole process.

"In addition, no one can say 'this is not going to work in real life,' since there are certain standards for research data which will be met all along the way.

"The Clinical Trials Network is a collaborative effort from the very beginning." Tai added that being named director of this exciting undertaking has been "one of the best assignments of my career."

"We're trying to create a culture change where researchers and treatment centers communicate with each and use each other's expertise to improve treatment and bring more important clinical issues under the microscope," Richard Rawson, PhD of UCLA told Counselor. He is the principal co-investigator with the Pacific Region Node, and the associate director of UCLA's Integrated Substance Abuse Programs in the Department of Psychiatry.

One protocol currently up and running at UCLA is a study of buprenorphine naloxone for heroin and morphine addicts. "We have three protocols in operation now, going into the field," said Rawson.

Other studies will examine treatment for methamphetamine and cocaine dependency.

"However, in Los Angeles we have a long history of research in community-based clinics. Most of this is through the Matrix Institute Clinics, which have been operating since the early 1980s, as a vehicle to translate research into practice. So for us, integrating research into the fabric of treatment centers is familiar territory.

"The relationship with the Betty Ford Center is a new one for us, and a new opportunity to connect research and treatment.

"Some researchers have no experience with the real world, as opposed to the research laboratory environment. For some, this is the first time they'll be speaking in the language of treatment. Everybody will be learning; the learning will be bi-directional," Rawson said.

Substance abuse professionals looking to get their patients into any of the CTN studies should investigate whether local universities are part of one of the nodes. According to Dr. Tai, the NIDA Web site will also be updated regularly with all the information on the universities and community treatment programs that are participating in the network.

To follow the progress of the Clinical Trials Network at the National Institute on Drug Abuse, look up their home page on the Internet at: www.drugabuse.gov.

"The real challenge will be once science demonstrates that it can enhance people's outcomes, to keep programs in place. That's when policy comes into it and funding.

The CTN is not a flash-in-the-pan project, but a long-haul effort to change the way substance abuse treatment center and research agendas are developed," Dr. Richard Rawson concluded.

Mary Ellen Hettinger is a freelance writer
in Amherst, New Hampshire.

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