Researchers at the University of Maryland School of Medicine (UMSOM) Institute of Human Virology (IHV) are collaborating with scientists at the National Institutes of Health to test an experimental drug to curb opioid cravings.
The clinical trial of an experimental drug designed to treat cravings associated with opioid use disorder (OUD) has begun in the National Institutes of Health Clinical Center. The Phase I trial in healthy adults will assess the safety of the experimental compound, ANS-6637, and how it is processed in the body when given with another drug that is processed by the same liver enzyme pathway. The NIH’s National Institute of Allergy and Infectious Diseases (NIAID) is helping to conduct the trial, which is funded through NIH’s Helping to End Addiction Long-Term (HEAL(link is external)) Initiative, a comprehensive program to accelerate research efforts to stem the public health crisis of OUD.
The trial will enroll up to 50 healthy adults aged 18 through 65 years. Participants will stay in the Clinical Center in Bethesda, Maryland, for 10 days and return for a final outpatient visit after one week. On the first day, volunteers will receive a single dose of the licensed drug midazolam. Midazolam was chosen because its processing by the body is well understood, acting as a template for liver metabolism. They will receive no drug on day two. On study days three through seven, volunteers will receive 600 milligrams of ANS-6637 each day. On day eight, participants will receive midazolam and ANS-6637 together to see how the investigational agent affects midazolam levels. This in turn will help researchers understand how ANS-6637 is processed by the body, setting up the next phase of scientific investigation in patients with OUD.
“Opioid use disorder is a treatable medical illness that, much like in the early days of HIV, has been held back from scientific advancement by stigma and misconception,” said Sarah Kattakuzhy, M.D., associate investigator and assistant professor at the Institute of Human Virology at the University of Maryland School of Medicine in Baltimore. “With the support of the HEAL Initiative and NIAID, we can now assess a novel potential therapeutic in the treatment of OUD. If proven effective, ANS-6637 could be part of a comprehensive package of services, including harm reduction, opioid agonist therapy and behavioral interventions, enabling us to offer our patients the highest level of evidence-based therapy.” Dr. Kattakuzhy and colleagues are planning further study of ANS-6637 as a treatment for OUD in clinical trials at the University of Maryland School of Medicine.
