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Opioids are generally prescribed to treat pain. With the prolonged use, the user can be addicted to it. Symptoms of addiction include an inability to control opioid use and uncontrolled craving even though it shows a negative effect on a personal relationship. Taking illegal opioids (heroin) may also lead to death. To treat the one, who getting addicted to opioids, the scientists at National Institutes of Health Clinical Center make an early stage trial on treating opioid craving.
Researchers at the UMSOM (University of Maryland School of Medicine) and IHV (Institute of Human Virology) collaborate with scientists at the National Institutes of Health (NIH) started the clinical trial to treat cravings associated with OUD (opioid use disorder).
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The phase I trial has started on healthy adults to evaluate the safety of experimental compound ANS-6637 and how it is processed in the body when it is provided with another drug. The NIAID (National Institute of Allergy and Infectious Diseases) helped NIH to conduct the trial.
The trial enrols up to 50 healthy adults aged from 18 to 65 years. The participants are asked to stay in the Clinical Center in Bethesda, Maryland for 10 days and provided with one week time to return for a final outpatient visit.
On the first day of trial, volunteers will receive a single dose of midazolam, licensed drug. This drug was chosen because it is easy to understand the process in human body. On second days, they will not receive any medication. From the third to the seventh day, the volunteers will receive up to 600 milligrams of ANS-6637. On the eighth day, they will receive ANS-6637 and midazolam together to learn how the investigational agent affects the midazolam level. By this way, researchers try to understand the working of opioid. This sets the next phase to investigate the patients with OUD.
These are the steps performed by the scientists on volunteers to understand the working of different doses of opioid drugs in human and aid them to conclude the way to treat opioid craving.