Request for Information on The HEALing Communities Study
NIDA, in partnership with SAMHSA, has released a Request for Information (RFI) for the HEALing Communities Study, part of NIH’s Helping to End Addiction Long-term (HEAL) Initiative. The HEALing Communities Study will test the implementation of an integrated set of addiction prevention and treatment approaches in an array of settings in up to three communities affected by the opioid crisis. Through this study, NIDA and SAMHSA aim to define effective strategies to reduce opioid overdose and overdose death, while increasing the number of individuals receiving medication-assisted treatment and the number retained in treatment and receiving needed recovery support services. The RFI seeks input on the design, study outcomes, and necessary partnerships and infrastructure for this multi-site research effort.
NIDA is playing a major role in the National Institutes of Health (NIH) HEAL initiative (Helping to End Addiction Long-term), launched in June 2018 to provide scientific solutions to the national opioid overdose crisis, including improved treatment strategies for pain as well as opioid use disorders (OUDs). This new initiative, funded by Congress, brings new hope for people, families, and communities affected by this devastating crisis.
NIDA will be coordinating four overarching research projects around the country:
Goal: Conduct a series of high-impact studies that will ideally lead to about 15 Investigational New Drugs (INDs), which would then produce around five New Drug Applications (NDAs) submitted to the Food and Drug Administration (FDA).
This project will focus on developing new addiction treatments and overdose-reversal tools. Three medications are currently FDA-approved to treat opioid addiction, and naloxone is available in both injectable and intranasal formulations to reverse overdose. But a wider range of options is needed in both areas. These may involve new formulations of existing drugs including longer-acting depot formulations of opioid agonists as well as stronger, longer-lasting naloxone formulations to more effectively reverse overdose from powerful synthetic opioids such as fentanyl. Research will also focus on compounds that target different receptor systems or immunotherapies to treat symptoms of withdrawal and craving in addition to the progression of opioid use disorders.
Goal: To determine if an integrated set of evidence-based interventions within healthcare, behavioral health, justice systems, and community organizations can work to decrease opioid overdoses and to prevent and treat opioid use disorders.
A great tragedy of the opioid crisis is that so many effective tools already exist but are not being deployed effectively in communities that need them. Only a fraction of people with opioid use disorders receive any treatment, and of those, less than half receive the medications that are universally acknowledged to be the standard of care, or they receive treatment for too short a duration. NIDA will work with the Substance Abuse and Mental Health Services Administration to launch a multisite implementation research study to identify the ideal sequence and duration of treatment within communities. Called the HEALing Communities Study, it will look at the effectiveness of a coordinated continuum of care in up to three targeted states. The studies will test the integration of prevention, overdose treatment, and medically assisted treatment in a coordinated array of settings–primary care; emergency departments; specialty care, including prenatal care, infectious disease, and behavioral health; the criminal justice system; and other community settings.
Goal: Expand NIDA’s existing Clinical Trials Network to reach more communities in areas of the country hard hit by the opioids crisis.
The National Drug Abuse Treatment Clinical Trials Network (CTN) facilitates collaboration between NIDA, research scientists at universities, and treatment providers in the community with the aim of developing, testing, and implementing new addiction treatments. The network has contributed to broad reaching changes in medical practice, including the development of the opioid treatment medication buprenorphine. The CTN Opioid Research Enhancement Project will greatly expand the CTN’s capacity to conduct trials by adding new sites and new investigators. The funds will enable the expansion of existing studies and facilitate developing and implementing new studies to improve access to high-quality addiction treatment, for example, by facilitating delivery of OUD treatment in general medical settings. It will also create new opportunities for clinical and research training.
Goal: Improve access to high-quality, evidence-based addiction treatment in justice settings.
Much research already points to the benefits of increasing access to treatment for opioid use disorders for justice-involved populations; however, it is unknown how many effective programs exist in different jurisdictions around the country, and which specific strategies are most effective. This project will create a network of researchers who can rapidly conduct studies aimed at exploring the effectiveness and adoption of medications, interventions, and technologies in those settings; and finding ways to use existing data sources as well as developing new research methods to ensure that interventions have the maximum impact. It will include implementing a national survey of addiction treatment delivery services in local and state justice systems.
Other NIH Institutes and Centers will also be involved in the NIH Heal Initiative. For example, the National Institute on Neurological Disorders and Stroke (NINDS) (see NINDS Director’s Message on the HEAL Initiative) will be funding projects to develop improved pain medications, compounds with the strength of opioids but without the risk of addiction. To see the NIH news release on the HEAL Initiative, and the full scientific research plan, go to NIH HEAL Initiative.
To see a related blog by Dr. Nora Volkow, go to An Ambitious Research Plan to Help Solve the Opioid Crisis.
To see the JAMA Viewpoint article, go to Helping to End Addiction Over the Long-term: The Research Plan for the NIH HEAL Initiative.