Renewed NIH Grant Supports ‘Real-World’ Drug Treatment Clinical Trials

A new grant from the National Institutes of Health (NIH) will support innovative clinical trials involving drug treatment by the Florida Node Alliance, based at the Miller School of Medicine. Over the past 15 years, the University team has received more than $73 million in funding from NIH’s National Institute on Drug Abuse, including a new five-year grant, which will provide more than $3 million in the coming year.

“Through the years, we have transformed the UM Center into a major hub for testing, refining and disseminating evidence-based drug addiction treatments into drug abuse treatment and primary care community-based settings,” said José Szapocznik, Ph.D., professor and Chair of Public Health Sciences and Director of the Miami Clinical and Translational Science Institute (CTSI). He is also principal investigator for the Florida Node Alliance, which is one of 13 centers that constitute the National Drug Abuse Treatment Clinical Trials Network (CTN).

Szapocznik works closely with the center’s multiple-PI Lisa Metsch, Ph.D., Columbia University Mailman School of Public Health Stephen Smith Professor and Chair of Sociomedical Sciences, and the center’s Executive Director, Viviana Horigian, M.D., associate professor of public health at the Miller School.

“The renewed funding provides a platform for continuing to improve the delivery of substance abuse treatments across the nation and internationally, as well as in South Florida,” said Horigian. “Substance abuse diagnosis and treatment is rapidly moving into the primary care setting. That’s a challenge for physicians, who need the knowledge and resources to provide that important service in a seamless manner.”

The Miller School-based researchers work closely with primary care physicians and other providers to design clinical trials that work in a “real-world” setting, said Szapocznik. “We also educate providers to conduct the actual clinical trials (with tight monitoring, supervision and coaching), so that they understand the nature of the research and how to conduct their own trials in the future if they choose to do so.”

Currently, the Miami center works with providers in Florida, Colorado, Georgia, North Carolina and Puerto Rico, and assists in clinical trials initiated by other CTN centers. Although based in New York, Metsch, a former Miller School faculty member, conducts most of her research in South Florida, while leading clinical trials across the country.

During the last 15 years, the Florida Node Alliance has participated in 16 trials involving behavioral and pharmacological drug abuse treatments in practice settings. One example of the Miami-based center’s impact was the implementation of a research project led by Metsch, as national principal investigator, with Daniel Feaster, Ph.D., associate professor of public health sciences at the Miller School, and Lauren Gooden, Ph.D., assistant professor of sociomedical sciences at Columbia University, that has guided HIV prevention policy and practice in substance use treatment. “Our studies have demonstrated the effectiveness and cost-effectiveness of offering on-site HIV testing in substance use treatment programs and have led to changes in HIV prevention policy to support streamlined and routine HIV testing in health care settings,” said Metsch.

In addition, this study coupled with the results from the follow-up ARRA-funded Project AWARE study (Metsch and Feaster were the PIs with Grant Colfax, M.D., from the San Francisco Department of Health) provided scientific evidence to demonstrate that the provision of risk reduction counseling at the time of HIV testing is an ineffective HIV prevention practice. This finding provided important data that led the CDC to change its counseling guidelines at the time of HIV testing.

Metsch, Feaster, and Gooden with Carlos del Rio, M.D., professor and chair of global health at Emory University, and Allan Rodriguez, M.D., professor of medicine at the Miller School, are now leading a study in the CTN to evaluate strategies to assist HIV-positive and HIV/HCV positive individuals in engaging in medical care and achieving virologic suppression.

Szapocznik was the national principal investigator on “Brief Strategic Family Therapy for Adolescent Drug Abusers” and co-lead investigator with Yale University’s Kathleen Carroll on “Motivational Enhancement Treatment to Improve Treatment Engagement and Outcome for Spanish-Speaking Individuals Seeking Treatment for Substance Abuse,” a study conducted with monolingual Hispanics across the U.S.

Horigian was principal investigator on an initiative to replicate the Miller School-based Clinical Trials Network model in Mexico’s National Institute of Psychiatry by transferring clinical trials research methods and drug abuse treatment technology to the institute and community-based treatment programs throughout Mexico City and later throughout Mexico. This model of clinical trial research methods technology transfer is now being used to create similar capabilities in Chile and Ecuador.

For the next five-year NIH grant cycle, the alliance plans to expand into a network of networks and bolster its research agenda by engaging health care providers, clinical and research networks, substance abuse specialty providers, scientists and informatics experts to build the research evidence on new models for mainstream and integrated substance use care and treatment. Building on the longstanding foundation of bi-directional partnerships among scientists, health systems and community-based clinical partners, the alliance ensures that study outcomes are clinically meaningful to patients, health care providers, and other key stakeholders such as payers.

“We are working at the edge of implementation science and the Affordable Care Act,” said Szapocznik. “This NIH grant will help us advance the integration of clinical trials into health care networks, randomizing patients and using electronic health records to evaluate outcomes over the next five years.”

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