UM Researchers Take Clinical Trial Expertise to Mexico

Miller School Epidemiology and Public Health researchers export their expertise to Mexico.

Coral Gables (June 10, 2011) — After years of conducting successful, randomized drug abuse treatment clinical trials for Spanish speakers and general populations in Florida and the nation, researchers from the Miller School’s Department of Epidemiology and Public Health are exporting their expertise to Mexico.

Armed with a two-year $1.2 million grant from the U.S. Department of State, they are training researchers at Mexico’s Ramón de la Fuente National Institute of Psychiatry to conduct randomized clinical trials in Mexico with the same rigor used in the U.S. National Institute on Drug Abuse’s National Drug Abuse Treatment Clinical Trials Network (NIDA-CTN).

The Mexico project marks the first time the NIDA-CTN is taking its technology and success abroad. The project, which includes consultation, supervision and monitoring after the training phase, could serve as a model for how to transfer drug abuse treatment research technology, backed by cultural competencies, to foreign countries.

“We are proud that the effects of what we do are seen as models that can be used to help people in other parts of the world,” said Viviana Horigian, research assistant professor and principal investigator who leads the UM grant team. “The project is being closely watched on national and international levels, but we’re confident it will work well and help open doors for the development of other research infrastructure for Spanish-speakers.”

During the first phase of the project, already underway here and in Mexico, the Miller School team will deliver didactic and skills-building modules to prepare Mexico’s National Institute of Psychiatry to conduct a pilot of the NIDA-CTN’s multisite, randomized study on the effectiveness of motivational therapy.

The study “Motivational Enhancement Therapy (MET) to Improve Treatment Engagement and Outcome for Spanish-Speaking Individuals Seeking Treatment for Substance Abuse,” was chosen because it has proven successful at motivating clients to adhere to treatment, a critical element missing in Mexican drug treatment centers.

Part of the State Department’s drug-fighting Merida Initiative, the UM-Mexico grant is an acknowledgement of the success of NIDA-CTN in general and, in particular, of the best practices developed by the clinical trials run by the Miller School-based Florida Node Alliance of NIDA’s Clinical Trials Network.

Originally led by principal investigator José Szapocznik and later joined by co-principal investigator Lisa Metsch, professor of epidemiology and public health, the node, a partnership among 13 university-based centers and more than 260 community-based drug treatment service agencies, has significantly impacted the drug abuse and problem-behavior arena over the past 11 years, translating clinical research into clinical practice through numerous sites in Florida, as well as in Colorado, North Carolina, and Puerto Rico.

“We are eager to help our colleagues in Mexico establish a clinical trials center to translate evidence-based treatments into practice by conducting trials in the front lines of practice,” said Szapocznik, the Miller School’s executive dean for research and research training and chair of the Department of Epidemiology and Public Health.

“What we have in the UM node is considerable know-how in the conduct of clinical trials in practice settings and specific expertise in HIV, adolescents and research with Hispanics, including experience leading and managing trials for monolingual Spanish-speakers,” Horigian said. “Our vast experience made us a perfect fit for the demand-reduction project of the Merida Initiative.”

The Merida Initiative was approved by Congress in 2008 to combat criminal enterprises that threaten U.S. national security. It provided an initial $400 million for Mexico and $65 million for Central America, the Dominican Republic, and Haiti for equipment, law enforcement training, technical assistance, and drug prevention and treatment strategies.

Even when proven effective elsewhere, such strategies have to be tailored to match nuances in language, culture, and other relevant differences in Mexico, a process Horigian and Rosa Verdeja, director for the project, began in their first two visits to Mexico. There they met with researchers from the National Institute of Psychiatry and toured a handful of the 330 treatment centers operating under guidelines from Mexico’s Consejo Nacional Contra las Adicciones (CONADIC), or the National Council Against Addictions.

“We saw different populations and different skill levels,” Horigian said of the tour. “What we’re doing requires us to understand how the agencies work in their real-world settings, and how best to transfer clinical trials technologies and evidence-based treatments in such settings. That’s the foundation of our work.”

Last month, a group from Mexico’s national institute visited Miller School researchers in Miami to review UM study protocols and procedures and help decide which would work in their country. They worked with Horigian and Verdeja and the rest of the team, including Elizabeth Alonso, director of quality monitoring; Maria Alejandra Perez; Ingrid Usaga, and Eric Ponce.

“It’s not only an issue of language; the cultural adaptation component is crucial,” Verdeja noted. “We cannot assume that Spanish-speakers in, say, Miami and Puerto Rico will respond in a similar manner. We will have to determine if the protocols chosen can be successfully adapted to local populations. This is a time that’s both challenging and exciting.”

“Long-term I hope our counterparts in Mexico will be able to become a center that can run their own clinical trials in a network of sites,” Horigian said. “We’re completely committed to lending our expertise to our neighbors.”

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Viviana Horigian (standing at left) and Rosa Verdeja (standing at right) lead a clinical trial protocols discussion with researchers visiting the Miller School from Mexico’s National Institute of Psychiatry.

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