The Helping to End Addiction Long-termSM Initiative, or NIH HEAL InitiativeSM, is an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis. This includes preventing opioid misuse, developing new addiction treatments, and making effective treatments accessible to the over 2 million people with opioid use disorder (OUD) in the U.S, as well as providing new solutions and new hope to the 50 million people suffering from chronic pain.
In Fiscal Year 2019, approximately 375 NIH HEAL Initiative grants, contracts, supplements, and cooperative agreements in 41 states, totaling $945 million, have been awarded to researchers and research teams across the U.S.—an unprecedented scientific investment that could go a long way toward achieving these important goals. The awards being announced today include funding from NIDA primarily in the areas of OUD prevention and treatment.
We have three effective medications to treat OUD—methadone, buprenorphine, and naltrexone, in a growing number of formulations. These are recognized as the first line of treatment, but the majority of people with OUD still never receive any treatment, and many healthcare and justice settings do not make medications available. Three major NIDA-led NIH HEAL Initiative projects, the expansion of the Clinical Trials Network (CTN), the Justice Community Opioid Innovation Network (JCOIN), and the HEALing Communities Study, are already getting started investigating ways to widen the scope of OUD treatment in settings where it is most needed, including rural areas.
One set of new NIDA CTN grants will be used to test ways to improve patients’ adherence to their OUD medication regimens to prevent relapse and facilitate recovery and to improve outcomes among those who want to discontinue medication treatment after being successfully stabilized. Studies will help determine predictors of relapse or identify markers that could help determine when medications could be discontinued with minimal relapse risk, along with strategies to protect from the adverse consequences should relapse occur. Another trial will test an intervention in primary healthcare settings to reduce opioid misuse that falls short of OUD and to prevent it from developing into an OUD. The Subthreshold Opioid Use Disorder Prevention (STOP) trial will examine how well the intervention reduces progression to moderate or severe OUD and its impact on overdose and risk behaviors associated with overdose. Another trial will evaluate models to be used in emergency departments for initiating buprenorphine treatment in those suffering from OUD.
Patients who receive medications for OUD often don’t remain on them for a sufficient duration to achieve long-term recovery. As part of the NIH HEAL Initiative , NIDA will fund the development and testing of new and innovative OUD treatments that can provide patients with a wider range of treatment options and help them stay in treatment. Approaches to be studied include immunotherapies, extended-release formulations of existing medications, and medications that support recovery by reducing drug cravings, sleep impairments, and withdrawal symptoms. Additionally, funding allocated through NIDA’s Small Business Innovation Research (SBIR) and Small Business Technology Transfer Research (STTR) program will support development of novel technologies to improve treatment entry, retention, and recovery.
Prevention of opioid misuse is also crucial to addressing the opioid crisis and will be a focus of the initiative. A particularly at-risk group is older adolescents and young adults. New NIDA grants will support studies testing interventions that are aimed at preventing prescription opioid misuse and the transition to OUD in this age group. Interventions will be developed and tested in a range of settings in hard-hit communities, including school and college health centers and other healthcare settings, as well as workplaces and criminal justice settings.
Another consequence from the opioid crisis has been the growing number of infants in the U.S. that are born physically dependent on opioids because of the mother’s exposure to opioids during pregnancy. However, little is known about the developmental consequences of this exposure, and currently there is no standard of care to help guide physicians in managing care for these infants. The NIDA-led HEALthy Brain and Child Development study (HBCD) planning grants, partially funded by NIH HEAL Initiative, will inform the design and ethical considerations that must be addressed to initiate a larger cohort study to determine how pre- and post- natal opioid (and other drug) exposure, as well as the effects of growing in a deprived environment or a stressful household, will affect brain growth and development, and how genes influence these interactions.
Although NIDA’s stake and responsibility in the initiative is substantial, we are not shouldering the whole burden. Our sister Institutes and Centers across NIH are simultaneously funding research in several other needed areas. These include research to develop better guidelines for the management of infants who have been exposed to opioids prenatally, the treatment of OUD and co-morbid mental illness and the value of behavioral interventions in OUD, and a wide variety of research projects to better understand and improve the treatment of pain, such as developing new pain medications and alternative pain treatments.
The NIH HEAL Initiative, which was launched in April 2018 by NIH Director Dr. Francis Collins, answers the need for a comprehensive research effort across all NIH Institutes and Centers whose work bears in some way on the opioid crisis. It is capitalizing on unprecedented governmental support and drawing on scientific expertise across many fields of biomedical research. Working together, with “all hands on deck,” I believe that we can bring an end to this crisis, and in the process make important scientific advances that will help us avert further crises related to drugs and addiction.
Learn more about the NIH HEAL Initiative programs and awards,