NIH’s HEAL Initiatives Keep Progressing Thanks to Scientists’ Ingenuity

In spite of the COVID-19 pandemic over the past year, work on the National Institutes of Health’s Helping to End Addiction Long-term (HEAL) initiative has kept progressing. NIH director Francis S. Collins, MD, PhD, and NIDA director Nora Volkow, MD, provided an update to Rx Drug Abuse & Heroin Summit attendees on Tuesday evening, sharing progress made on a number of treatment interventions in development and anecdotes on recently emerging substance use trends.

HEAL, which has directed more than $1.5 billion in funding to researchers and communities since its inception, is now actively recruiting participants for studies on family-based prevention programs, culturally tailored interventions for certain populations, and interventions that address social inequities, such as lack of housing, Collins said. A test for a vaccine to protect against the harmful effects of opioids is underway, as is testing for a tool that could provide pharmacists with a validated opioid use disorder risk measure to more effectively identify individuals at a heightened risk for opioid addiction, he said.

Another HEAL-backed study is looking at a non-medication intervention for neo-natal opioid withdrawal. The device, a gently vibrating pad placed in a baby’s bassinet, has received breakthrough device designation by FDA.

The resilience and ingenuity of the scientific community throughout the pandemic “has been impressive,” Collins said, adding that quick pivots have sparked significant gains in research around the expansion of telehealth services, adaptation of treatments for pain and substance use disorders, and new ways to recruit patients through digital platforms.

Providers’ concerns that conditions created by the pandemic could lead to a rise in substance use, however, have proven well founded, Volkow said. Officials had theorized that closing borders would cut off the flow of illicit substances coming into the country. That did not happen.

“Unfortunately, what we’ve seen is that the stress of the uncertainty has resulted in an increase in drug use of all types…and an exacerbation of the opioid epidemic, as evidenced by the number of people who have died,” Volkow said.

Preliminary data from CDC through July 2020 showed a 24% nationwide increase in mortality from overdoses, as well as an increase of more than 40% in overdose deaths associated with fentanyl, Volkow said. The highest increase in mortality from opioids, predominantly driven by fentanyl, is now among Black Americans, and the risk of methamphetamine overdose has been shown to be 12 times higher among American Indian and Alaska Native populations vs. the overall U.S. population, Volkow said.

Fentanyl is also playing a role in 50% of deaths associated with methamphetamine and cocaine overdoses, Volkow said. Dealers are stretching their supplies of cocaine—a result of pandemic-related border shutdowns—by mixing in fentanyl. That mixture is deadly for individuals addicted to stimulants but who also have low tolerance for opioids, Volkow said.

Volkow also highlighted progress being made on several medications. A clinical trial launched earlier this year to investigate the benefits combining two medications that had been approved for smoking cessation and alcohol addiction. Early results have shown the medications in combination have significantly inhibited the urges of patients with moderate to severe methamphetamine addiction. Other medication developments include progress on an antidote for fentanyl overdoses, longer-lasting medications for treating opioid use disorder, and an overdose-reversal medication for methamphetamine similar to naloxone for opioid overdoses. That medication is now in being evaluated in a Phase II study, Volkow said.