At the 2018 National Rx Drug Abuse and Heroin Summit, National Institutes of Health Director Francis S. Collins, M.D., Ph.D., announced the launch of the HEAL (Helping to End Addiction Long-term) Initiative, an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis. Toward this effort, NIH is nearly doubling funding for research on opioid misuse/addiction and pain from approximately $600 million in fiscal year 2016 to $1.1 billion in fiscal year 2018, made possible from a funding boost by Congress.

NIH’s efforts contribute to a government-wide push to meet the President’s goal of ending the opioid crisis.

“Every day, more than 115 Americans die after overdosing on opioids,” said Dr. Collins. “That is a four-fold increase since 2000, and the numbers continue to climb.  NIH has been deeply invested in efforts to counter this crisis through research, but we are determined to do even more. Over the last year, NIH has worked with stakeholders and experts across scientific disciplines and sectors to identify areas of opportunity for research to combat the opioid crisis. The focus of these discussions has centered on ways to reduce the over prescription of opioids, accelerate development of effective non-opioid therapies for pain, and provide more flexible options for treating opioid addiction. NIH is committed to bringing the full power of the biomedical research enterprise to bear on this crisis.”

HEAL will bolster research across the NIH to:

Prevent Addiction through Enhanced Pain Management:

• Launch a longitudinal study to follow patients 1) after acute onset of musculoskeletal pain and 2) after surgery to identify biomarkers that might predict which individuals are more likely to transition from acute to chronic pain. 
• Leverage innovative imaging and -omics neurotechnologies developed through the NIH BRAIN Initiative and SPARC program to identify 1) potential new targets for treatment of chronic pain and 2) objective biomarkers to predict which individuals will respond to a treatment.
• Advance understanding of the genetic and social factors that put patients at risk for opioid misuse and addiction to inform precision prevention strategies tailored to individual risk factors.
• Define and support best practices for pain management using nondrug and integrated therapies for specific pain conditions by building on research from the National Center for Complementary and Integrative Health, the U.S. Department of Veterans Affairs, and Department of Defense research collaborative to address the needs of service members and veterans.
• Pursue public-private partnerships to develop new non-addictive pain medicines by sharing data on past and present research projects, and matching researchers with a selection of potentially promising but abandoned pharmaceutical industry compounds to explore their effectiveness for the treatment of pain.
• Build a clinical trials network that will allow multiple new and repurposed compounds to be tested simultaneously for effectiveness.  This allows ineffective compounds to be weeded out and new compounds to enter trials more swiftly.  The combination of testing compounds that already have received large investments and passed safety testing, and a flexible clinical trials network will significantly accelerate the development of effective therapies.

Improve Treatments for Opioid Misuse Disorder and Addiction:

• Expand therapeutic options for treating addiction, including extending the options for Medication-Assisted Therapy (MAT) and overdose reversal treatments. Develop immunotherapies that enlist the immune system to block entry of heroin or synthetic opioids to the brain to prevent overdose or relapse for individuals at high risk for addiction. Compare already proven MAT in combination with other nondrug approaches such as cognitive therapy and meditation. 
• Evaluate treatments and long-term consequences of Neonatal Opioid Withdrawal Syndrome by expanding the Advancing Clinical Trials in Neonatal Opioid Withdrawal Syndrome (ACT NOW) project, tapping into the Environmental Child Health Outcomes and IDeA States Pediatric Clinical Trials Network.
• Working with federal and state partners, pilot demonstration projects to test the integration of multiple addiction prevention and treatment options in healthcare and criminal justice settings in states with the highest rates of opioid misuse and overdose to inform evidence-based practice.  Despite multiple effective prevention and treatment approaches, the majority of the 2 million Americans with opioid use disorder do not receive appropriate or adequate treatment for their addiction.

“Science and technology have illuminated our understanding of the mechanisms underlying addiction,” said Nora D. Volkow, M.D., director of the National Institute on Drug Abuse.  “With these additional resources, we can develop more customized, high-quality treatments for addiction and pain, as well as harness implementation science to bring evidence-based changes to our healthcare system, including treatment for those in the criminal justice environment.”  

The NIH HEAL Initiative will build on extensive, well-established NIH research that has led to successes such as the development of the nasal form of naloxone, the most commonly used nasal spray for reversing an opioid overdose; the development of buprenorphine for the treatment of opioid use disorder; and the use of nondrug and mind/body techniques to help patients control and manage pain, such as yoga, tai chi, acupuncture, and mindfulness meditation. The Initiative will tap into the expertise of the NIH Pain Consortium, which was established to enhance collaboration among NIH institutes, centers and offices that conduct pain research.

“This nationwide crisis stemmed initially from over-prescribing of opioid medications to treat pain,” said Walter J. Koroshetz, M.D., director of the National Institute of Neurological Disorders and Stroke, the lead NIH institute on pain. “The HEAL Initiative will develop the scientific evidence that informs best practices to effectively treat patients with pain while preventing addiction.  A major focus will be to understand why some people go from acute to chronic pain, with the intent to prevent that transition.  Importantly, the Initiative will drive the science to enable the development of powerful, non-addictive pain treatments that would limit the need for opioid medications in the future.”