University of Maryland School of Medicine (UMSOM) Dean Mark T. Gladwin, MD, announced on Dec. 11 that the school will receive a $29 million research award over four years from the National Institutes of Health (NIH) to lead a multi-center trial that aims to improve health outcomes in people who inject opioid drugs and are hospitalized with infectious complications of their drug use. Faculty affiliated with the Institute of Human Virology (IHV) and the Kahlert Institute for Addiction Medicine at UMSOM will be conducting the research.
The research award, which has provided $8.7 million in funding for the first year, is funded by the NIH’s Helping to End Addiction Long-term Initiative (NIH HEAL Initiative) for the implementation of the Continuum of Care in Hospitalized Patients with Opioid Use Disorder and Infectious Complications of Drug Use (CHOICE) investigation. Principal IHV investigators are Sarah Kattakuzhy, MD, MPH, associate professor of medicine at UMSOM, and Elana Rosenthal, MD, associate professor of medicine at UMSOM, with co-investigator Edward Traver, MD, assistant professor medicine at UMSOM.
“Our current research demonstrated that patients with substance use disorder hospitalized for infectious complications are prone to have negative outcomes. There is a limited understanding of what interventions can best improve outcomes in people who use drugs, especially in the vulnerable time period after hospitalization,” said Kattakuzhy, who also is associate director of the Kahlert Institute. “The CHOICE investigation will test multiple interventions to improve outcomes in this vulnerable population.”
Sarah Kattakuzhy, MD, and Elena Rosenthal, MD
People who inject drugs have an increased risk of contracting infections including local injection-related infections to serious infections, like bacteremia (blood infections) or endocarditis (heart infection), that can be life-threatening.
“Marylanders have been significantly affected by the ongoing opioid epidemic. This tragedy not only affects the well-being of people in our state, but also has put a major burden on our health care system. That is why I am proud to congratulate the Institute of Human Virology at the University of Maryland School of Medicine on their recent award from the NIH HEAL Initiative,” said U.S. Sen. Ben Cardin (D-Md.). “I am confident that the team at IHV will continue their work to give us a better understanding of this critical issue.”
In addition to the CHOICE study, UMSOM has made it a critical part of its mission to drive innovation in the field of addiction medicine. Last May, the school opened the Kahlert Institute.
“Those who use illicit IV drugs are up to 50 times more likely to be admitted to the hospital for a bacterial infection compared to patients in the general population,” said Gladwin, who also is the John Z. and Akiko K. Bowers Distinguished Professor, UMSOM, and vice president for medical affairs, University of Maryland, Baltimore. “The landmark CHOICE research study aims to prevent these life-threatening infections by identifying and overcoming specific barriers to care for these high-risk patients. This aligns with the efforts of the Kahlert Institute to identify and implement the best evidence-based harm-reduction measures that minimize the negative consequences of drug use on a patient’s overall health.”
CHOICE, led by IHV’s Research Initiative on Infectious Disease and Substance Use, is a multi-center trial led by IHV faculty that will develop an informed intervention to improve health outcomes in people who inject drugs hospitalized with infectious complications of injecting opioids. It will aim to recruit about 700 patients over three years from the University of Maryland Medical Center and hospitals affiliated with Emory University, George Washington University, and West Virginia University. Any patients admitted to the hospital for infections related to intravenous drug use potentially will be eligible to enroll in the study.
“Providing care to those who struggle with opioid use presents unique and complex challenges for both doctors and patients. With this major federal investment, the IHV will lead critical research right here in Maryland to advance our understanding of how to better treat the serious health complications these patients often face,” said U.S. Sen. Chris Van Hollen (D-Md.). “This work is a vital part of our comprehensive approach to combat the opioid epidemic and improve the lives of Americans who have been impacted by it.”
It is crucial to gain a comprehensive understanding of the effects of interventions aimed at addressing opioid use disorder (OUD) throughout a patient’s entire care journey, encompassing their initial hospitalization and the period following discharge. The knowledge gained from CHOICE is vital for enhancing the long-term well-being of people who inject drugs.
“This program draws on more than a decade of experience that this team has had in Washington, D.C, and Baltimore, developing both innovation and implementation strategies to reduce the burden of two major pandemics, HIV and opioid use disorder, in urban America,” said Henry Masur, MD, chief of the Critical Care Medicine Department at the NIH Clinical Care Center in Bethesda, Md. “This UMSOM multi-center project will develop important information to inform public health policies for dealing with substance use disorder, and on HIV.”
In the last 20 years, opioid overdose deaths have increased nationally by over 435 percent. In Maryland, the overdose death rate has more than doubled since 2015 — accounting for 5 percent of all deaths in the state. In Baltimore, 964 deaths were attributed to opioid overdose in 2020, nearly triple the number of deaths from homicide. Deaths and disability from infections related to IV opioid drug use adds to this devastation.
“People injecting drugs have debilitating and life-threatening infectious complications, which are challenging to manage in isolation without providing supportive care for opioid use disorder. The CHOICE study will evaluate a novel model of care in four major hospitals significantly affected by OUD to improve outcomes,” said Shyamasundaran Kottilil, MD, PhD, interim IHV director and director of the Division of Clinical Care and Research. “This study led by Drs Kattakuzhy, Rosenthal, and Traver utilizes a unique design of specific interventions, which I believe will transform how we take care of patients who are injecting drugs with infections admitted to the hospital in the future.”
The research team will spend the next several months conducting a needs assessment to determine the design of a randomized clinical trial that will test interventions to identify which work best to prevent re-hospitalizations for infectious diseases related to IV drug use. Interventions likely will include a combination of improving access to primary care services, better care coordination, and providing easier access to opioid use disorder medications like methadone and buprenorphine. They also will include harm-reduction techniques like access to sterilized needles.
“The status quo is not meeting the needs of these patients, who have incredibly high rates of morbidity and mortality,” Rosenthal said. “This study will address an unmet need that our research uncovered, and we are hopeful it will improve the outcomes of patients we see hospitalized with infectious complications of injecting opioids.”
The research project reported in this news release is supported by the NIH HEAL Initiative under award number 75N90023C00013. The content is solely the responsibility of the authors and does not necessarily represent the official views of NIH.
“Taking care of people who use drugs and have serious infection is complicated,” said Traver, the co-investigator who leads the Maryland site. “The CHOICE study is being conducted at four large academic health centers in the United States, all encountering the challenges of the opioid epidemic and associated infections. We are hoping to leverage their vast experience to further improve our care using a novel, site-specific, intervention-based study design.”