The NIH HEAL Initiative 2024 Annual Report: RESEARCH IN ACTION
January 31, 2024
TABLE OF CONTENTS
- From the Scientific Directors
- Selected Research Accomplishments
- Scientific Solutions for Equitable Care
- Research to Address Whole Person Needs
- Putting Research into Practice
- Targeted Discovery
- Sustaining HEAL's Future
FROM THE HEAL SCIENTIFIC DIRECTORS
Walter J. Koroshetz, M.D., Director, National Institute of Neurological Disorders and Stroke
Nora D. Volkow, M.D., Director, National Institute on Drug Abuse
As scientific directors of the Helping to End Addiction Long-term® Initiative, or NIH HEAL Initiative®, we are inspired by the progress and potential of this critical research effort as it enters its sixth year. The expansive HEAL research portfolio represents an unprecedented commitment to advancing science through more than 1,800 projects in all 50 states. We are living up to our promise to create innovative solutions with the potential to transform lives and communities affected by opioid use disorder and pain.
As demonstrated in the following pages of this year’s HEAL Annual Report, the initiative is an innovative approach to science that is comprehensive, whole-person-focused, and integrated. As a research community, HEAL embraces the complexity of addiction, pain, and the intersection of both – recognizing their multifaceted biological, psychological, social, and environmental dimensions. Overcoming health disparities, improving clinical care, and developing new treatment options demand that we work closely with patients and communities to put new findings into practice. Meanwhile, we continue to address foundational issues including data collection and sharing, as well as building and sustaining a workforce of researchers dedicated to finding scientific solutions for pain, substance use disorders, and overdose.
A core HEAL value is reaching underserved populations, acknowledging many existing inequities that have exacerbated these intertwined health crises. Nearly 110,000 lives are lost annually to overdose, and 20 percent of Americans live with chronic pain. As devastating as these statistics are, they do not adequately capture the impact of this crisis, particularly on people historically underserved by the medical system. These include people who are Black, Hispanic, or American Indian/Alaska Native, those living in rural areas, people with co-occurring conditions, and people who experience social and economic disadvantages and often face barriers to accessing effective treatment and comprehensive care.
HEAL efforts are driven by the imperative to ensure inclusive and culturally competent research that can bridge gaps in care. For example, the Native Collective Research Effort to Enhance Wellness (N CREW) program will build collaborations with Tribes and Native American Serving Organizations to reduce health disparities and increase wellness. Recognizing that Native Americans have been disproportionately affected by overdose and chronic pain, and that understanding and leveraging community strengths are critical, N CREW fosters community-prioritized and -led research to address opioid use, pain, and related factors such as mental health and wellness in Native communities. The program also recognizes the value and legitimacy of Indigenous Knowledge and local expertise to advance science and strengths-based and sustainable solutions that are relevant and effective for Native American communities.
We also see the urgent need to address disparities in pain diagnosis and care through HEAL research. A new HEAL program is aiming to find pain management interventions that work for rural populations, leveraging infrastructure from existing HEAL clinical research. HEAL pain research studies dedicated to populations that experience health disparities are underway and meeting their milestones, developing strategies for enrolling participants who are typically underrepresented in research and ensuring that planned interventions are culturally appropriate, scalable, and sustainable, and which are centered around meaningful patient and community engagement practices. The Integrative Management of chronic Pain and OUD for Whole Recovery (IMPOWR) research program supports a network of multidisciplinary teams bringing a whole-patient focus to care for patients. This research network is developing and testing combined therapies including medications for opioid use disorder, behavioral treatments, and pain self-management – and they are examining implementation barriers. We also know that many individuals with chronic pain without an opioid use disorder experience additional opioid-related harms. The newly launched Multilevel Interventions to Reduce Harm and Improve Quality of Life for Patients on Long Term Opioid Therapy (MIRHIQL) program aims to develop and put into place actionable solutions for these individuals, including reducing opioid-related harms, improving pain, and enhancing quality of life.
Some individuals with substance use disorders are not ready or able to enter treatment. Keeping these people safe is a HEAL focus and a priority of the Biden-Harris Administration. We are funding research on overdose prevention including naloxone distribution and fentanyl test strips as part of the newly launched Harm Reduction Research Network, which will also study innovative ways of expanding the reach of these life-saving measures through mobile vans, tools delivered via smartphones, and other means. Several HEAL programs are working hard to implement evidence-based care within a variety of health care and community settings (such as primary care, emergency departments, jails, and child welfare).
Given very little industry investment in medications for either substance use disorders or pain, the National Institutes of Health (NIH) must fill this gap by supporting the development of new treatments for these conditions. And, indeed, the NIH HEAL Initiative has enabled tremendous strides in treatment development. Progress to expand the pipeline of medications for opioid use disorder and overdose continues to be exceptional – far exceeding HEAL’s initial goal of filing 15 investigational new drug (IND) applications to the U.S. Food and Drug Administration (FDA) in the first 5 years of initiative. In the past year alone, five new IND applications were submitted, and another five were cleared by the FDA. Currently, the program has 25 active INDs, including first-in-class monoclonal antibodies against fentanyl and methamphetamine, and one active investigational device exemption (IDE) that allows an experimental technology to be tested in people. Progress has been made in pain as well. This past year, HEAL scientists developed a chronic pain “brain signature” by measuring real-time, pain-related brain recordings in people with chronic pain disorders caused by stroke or amputation. Knowing more about how to use these pain signatures paves the way for developing non-invasive, targeted treatments.
After 5 years of research, we will soon have results from many HEAL clinical trials currently underway. We expect the results of these critical studies to yield new medications and interventions for opioid use disorder and overdose, including invasive and non-invasive neuromodulation tools – as well as a range of new, non-addictive pain management strategies, including medications, behavioral therapies, physical therapy and exercise-based interventions, and technologies. As you will see in this year’s HEAL Annual Report, our research is rooted in collaboration, partnership, and a shared commitment to advancing science for the greater good. Among the accomplishments that follow are solutions that offer patients and communities hope and provide the groundwork for future research successes.