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NIH Funds Early Clinical Trial to Test Experimental Drug on Opioid Cravings

ANS-6637 may reduce “surges” without affecting dopamine brain levels.

A PPM Brief

The National Institutes of Health’s (NIH) Clinical Center is conducting a Phase I trial of the experimental compound ANS-6637, currently in development by Amygdala Neurosciences (Palo Alto, CA) and designed to treat opioid cravings associated with opioid use disorder (OUD).1 The trial will examine how the drug is processed in the body when given with another drug (midazolam) that is processed by the same liver enzyme. With help from the National Institute of Allergy and Infectious Diseases (NIAID), the trial is funded through NIH’s Helping to End Addiction Long-Term (HEAL) Initiative, aiming to accelerate research efforts related to OUD, otherwise known as opioid addiction.

Habitual use of opioids affects dopamine levels and “rewires” the brain’s reward system, generating irresistible cravings to opioids and cues such as injecting equipment and/or drug use partners. Preclinical animal studies have suggested that ANS-6637 inhibits the dopamine surge that accompanies opioid use in persons with OUD, without impacting the brain’s background levels of dopamine.

“Opioid use disorder is a treatable medical illness that has been held back from scientific advancement by stigma and misconception,” said associate investigator Sarah Kattakuzhy, MD, assistant professor at the Institute of Human Virology at the University of Maryland School of Medicine, in an NIH press release. “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.”

ANS-6637 may reduce “surges” without affecting dopamine brain levels. (Source: 123RF)

The trial will enroll 50 healthy adults aged 18 to 65 for 10 days at the NIH Center in Bethesda, MD, with a final outpatient visit after one week:

  • On Day 1, volunteers will receive a single dose of midazolam; its well-understood body processing will act as a template for liver metabolism
  • Volunteers will receive no drug on Day 2
  • On Days 3 to 7, volunteers will receive 600 mgs of ANS-6637
  • On Day 8, participants will receive both midazolam and ANS-6637 to see how the investigational agent affects midazolam levels, helping to understand how ANS-6637 is processed in the body.

“At this time, there are few pharmacological interventions that specifically target the cravings felt by some patients who have physical dependence or opioid use disorder,” noted principal investigator Henry Masur, MD, chief of the Clinical Center’s Critical Care Medicine Department. “This trial will lay the groundwork for future studies; together these may lead to effective treatments for the drug cravings that impede the pursuit of sobriety.”

Dr. Kattakuzhy and colleagues noted that they are planning further studies of ANS-6637 out of the University of Maryland School of Medicine.

Last updated on: April 15, 2019
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