Can Clinical Trials Help Stem the Opioid Overdose Epidemic?

Nora Volkow, MD, Director of the National Institute on Drug Abuse

Nora Volkow, MD, Director of the National Institute on Drug Abuse

Opioid overdose deaths have quadrupled in the U.S. in the past 18 years, according to the Centers for Disease Control and Prevention (CDC). Nearly 200,000 Americans have died as a result.

Calling it a public health crisis, Ohio Senator Rob Portman called on federal authorities to step up and help confront it. “The [Food and Drug Administration] and [Department of Health and Human Services] should be more aggressive pushing treatments through the pipeline,” he told attendees of “America’s Opioid Epidemic: Search for Solutions,” an event sponsored by The Hill newspaper on September 13.

Nora Volkow, MD, director of the National Institute on Drug Abuse (NIDA), called on disparate groups to join forces. “Public and private partnerships must work together to develop alternate medicines,” she said. Some medicines work for a time, but can become less effective over time. The same medicines sometimes don’t work at all for a segment of the patient population, she said. Developing new medicines and treatment regimens will improve trial compliance, she added.

“We need new models of [drug] treatment, and incentives for public/private partnerships,” Volkow said. “It a very complex problem.”

According to the CDC, “there are signs” the opioid epidemic is on the rise, added Congressman Paul Tonko, vice chair of the Congressional Addiction, Treatment, and Recovery Caucus.

Working within the National Institutes of Health (NIH), NIDA has been active developing programs to help improve the quality and efficiency of clinical trials. For example, starting with application receipt dates on or after January 25, 2018, NIH will require that all applications for NIH funding for projects involving one or more clinical trials be submitted through a Funding Opportunity Announcement (FOA) specifically designed for clinical trials. After that date, applications won’t be reviewed unless applicants have joined the program.

For more information on NIH/NIDA initiatives, go to

Author: Michael Causey