Университет Юты получил 30 миллионов долларов для клинического исследования лечения алкогольного абстинентного синдрома

Alcohol withdrawal syndrome (AWS) is a serious and potentially life-threatening condition that affects an estimated 16% of people admitted to U.S. hospitals. AWS can occur when a person who regularly drinks alcohol suddenly stops, causing symptoms that range from agitation and hallucinations to seizures and, in the most severe cases, death. Although treatment practices have evolved in recent years, additional research is needed to determine which approaches lead to the best outcomes for patients. University of Utah Health has been awarded $30 million from the Patient-Centered Outcomes Research Institute (PCORI) to lead a large clinical study focused on identifying the most effective treatment for AWS. The study will compare phenobarbital, a newer treatment approach, with benzodiazepines, the established standard of care. Valerie Vaughn, M.D., associate professor of internal medicine at the Spencer Fox Eccles School of Medicine at the University of Utah, will lead the study, to be carried out through two large, multicenter randomized clinical trials involving 8,400 patients across 19 hospitals. Richard Holubkov, Ph.D., professor of pediatrics at the School of Medicine and investigator at the Utah Data Coordinating Center, will lead data collection, standardization, and analysis for all trial sites. "Right now, we don't know the best way to support patients withdrawing from alcohol, and different hospitals do it differently," Vaughn said. "Not only can that physically harm patients, but it can make it harder to establish the good relationships that are needed to help them enter long-term alcohol use treatment." "This trial is the first step toward helping us better support patients through a very difficult time. And we're doing it by engaging the entire team and community in creating and implementing the study." The research addresses a critical clinical question, with the potential to help patients and their care teams make better-informed health care decisions. Specifically, this patient-centered comparative clinical effectiveness research (CER) project will determine which medication controls symptoms faster and more safely for patients at higher risk for severe AWS complications. For patients at lower risk, the trial aims to determine which medication and dosing strategy works best. The study's primary outcome is the time it takes to bring AWS symptoms under control. Researchers will also assess the treatment's effects on nursing workload, hospital operations, and patient experience. "PCORI funds patient-centered comparative clinical effectiveness research focused on outcomes that matter most to individuals and generates evidence to support the health care decisions patients and those who care for them face every day," said Nakela L. Cook, M.D., M.P.H., executive director at PCORI. "By addressing a critical evidence gap in alcohol withdraw syndrome care, this large-scale study has the potential to improve patient outcomes and the quality of care. We look forward to following its progress." The study was selected for funding through a PCORI initiative designed to support large-scale, high-impact patient-centered CER trials using a multiphase format that allows for testing and refining the study approach. It will begin with an initial feasibility phase to maximize the likelihood of full trial success. Vaughn said the study's design could also help advance research in other areas. "If our approaches for implementing these trials in emergency settings are successful, they open the door for us to be able to study many of the hard treatment questions that are important to our patients and then apply those answers quickly to help all of our patients hospitalized at the university." The funding award to Vaughn, working with project co-lead Holubkov, has been approved pending completion of PCORI's business and programmatic review and issuance of a formal award contract. PCORI is a nonprofit organization with a mission to fund patient-centered CER designed to provide patients and those who care for them with evidence to make better-informed health care decisions.