Key Dates

NOT-MH-21-005 - Notice of Intent to Publish a Funding Opportunity Announcement for HEAL Initiative: Optimizing Multi-Component Service Delivery Interventions for People with Opioid Use Disorder, Co-Occurring Conditions, and/or Suicide Risk (R01 Clinical Trials Optional)

NOT-DA-20-077 - Notice of Intent to Publish a HEAL Funding Opportunity Announcement for Research on Related DSM-5 Diagnoses (R2D2) Coordination and Dissemination Center

National Institute on Drug Abuse (NIDA)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

National Center for Complementary and Integrative Health (NCCIH)

The National Institute on Health (NIH) intends to publish two Funding Opportunity Announcements (FOA) to solicit applications to build a network of researchers to develop sustainable evidence-based interventions to effectively treat non-cancer chronic pain (CP) and opioid use disorder (OUD). This network will be part of the of the NIH’s Helping to End Addiction Long-term (HEAL)^SM Initiative to speed the development and implementation of scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative will bolster research across NIH to (1) improve treatment and prevention of opioid misuse and opioid use disorder and (2) enhance pain management.

The purpose of this notice is to allow potential applicants sufficient time to develop meaningful collaborations and projects. This FOA is expected to use a collaborative program grant mechanism (RM1). The FOA is expected to be published in November 2020 with an expected application due date in January/February 2021.

This study will be part of the of the NIH’s Helping to End Addiction Long-term (HEAL)^SM Initiative to speed the development and implementation of scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative will bolster research across NIH to (1) improve treatment and prevention of opioid misuse and opioid use disorder and (2) enhance pain management. More information and periodic updates about the HEAL Initiative is available at: https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative.

More than 50 million Americans suffer from non-cancer chronic pain (CP) and a high proportion of these individuals are physically dependent on opioids. At the same time, it is estimated that more than 2 million Americans have an opioid use disorder (OUD). CP and OUD overlap significantly and patients with both conditions (i.e. those with comorbid pain and OUD) present particular clinical complexity. CP adversely impacts OUD treatment adherence and recovery, and the presence of dependence stigmatizes treatment services for chronic pain, often resulting in insufficient pain treatment. Fundamentally, the healthcare system lacks the expertise and effective interventions for managing comorbid CP and OUD, leaving patients suffering and at risk for poor outcomes.

NIH recognizes the importance in acknowledging the whole patient. Among patients with CP conditions, including those with OUD, a significant number also have Alcohol Use Disorder (AUD) or self-medicate pain with alcohol. Given the higher prevalence of General Anxiety Disorder (GAD) and Major Depressive Disorder (MDD) in people with co-occurring OUD and CP, these common comorbidities may complicate how best to effectively manage comorbid CP and OUD. This initiative will encourage fostering innovative multidisciplinary approaches across specialties to identify appropriate treatment interventions and measuring outcomes of relevance to this patient population.

Of note, researchers interested in examining approaches to improve multi-component health service delivery interventions for OUD and co-occurring mental health conditions are encouraged to review other relevant NIH programs (https://www.nimh.nih.gov/funding/grant-writing-and-application-process/concept-clearances/2020/optimizing-multi-component-service-delivery-interventions-for-people-with-opioid-use-disorder-co-occurring-conditions-and-or-suicide-risk-heal.shtml).

Network Structure and Objectives

This network is intended to facilitate multidisciplinary collaborations that can create actionable, translatable, and sustainable treatments for individuals who have comorbid CP and OUD. It is expected that there will be significant collaboration across the network and network components. Components of the proposed network will include:

• Centers on Co-managing Chronic Pain and Opioid Use Disorder (C3PO). The C3POs will emphasize clinical research and adaptive clinical trials, including pragmatic clinical effectiveness, implementation and hybrid implementation-effectiveness studies.
• Research on Related DSM-5 Diagnoses (R2D2) Coordination and Dissemination Center. The R2D2 Center will emphasize managing logistics, harmonizing common data elements, dissemination of findings and products generated by the network, coordination across programs, and awareness of ongoing research findings both within and external to the NIH HEAL Initiative. Of importance, R2D2 will facilitate areas of synergy between the C3PO and other relevant NIH programs (see NOT-20-077)

Consortium on Co-managing Chronic Pain and Opioid Use Disorder (C3PO)

This FOA is intended to run in parallel with a companion FOA that solicits applications for a Coordination and Dissemination Center (see NOT-DA-20-077). Applications for each component must be submitted separately.

For the C3PO, key capacities and efficiencies will include executing a range of clinical research approaches (e.g., pragmatic clinical effectiveness, implementation, and hybrid implementation-effectiveness trials) to treat comorbid CP and OUD. Applicants are expected to execute three program projects. Applicants are encouraged to examine if the intervention alters AUD, GAD, and MDD outcomes as secondary measures. Investigators are encouraged to review other NIH concepts that optimize multi-component service delivery interventions for people with OUD and co-occurring mental health conditions to understand distinctions in research priorities between the two initiatives and areas of synergy (https://www.nimh.nih.gov/funding/grant-writing-and-application-process/concept-clearances/2020/optimizing-multi-component-service-delivery-interventions-for-people-with-opioid-use-disorder-co-occurring-conditions-and-or-suicide-risk-heal.shtml).

High priority areas of research for this network includes: (1) Integrated care approaches for managing comorbid CP and OUD; (2) Adapting evidenced-based practices (EBPs) established for CP or OUD to effectively manage both conditions; (3) implementing CP treatments or medication for opioid use disorder (MOUDs) in diverse health care settings to increase the reach of EBPs for CP and OUD. Programs may have the option to develop novel treatments/interventions as pilot studies. Applicants will also be expected to demonstrate capacity to execute trials in a minimum of 3 distinct sites for integrated care approaches and adapted EBPs trials (i.e., high priority areas #1 and #2), and a minimum of 5 distinct sites for implementation studies (i.e., high priority area #3). Applicants are also expected to examine patient-centered outcomes, both holistic (e.g., capturing the patient narrative and measuring outcomes of importance to them) and component Patient-Reported Outcomes (PROs) and engage with other key stakeholders in addition to the patient population. Relevant stakeholders may include, but are not limited to: payors, care takers, health care providers with OUD and CP expertise, policymakers, advocacy groups, professional organizations that create clinical care guidelines.

HEAL Initiative

This study will be part of the of the NIH’s Helping to End Addiction Long-term (HEAL) Initiative to speed the development and implementation of scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative will bolster research across NIH to (1) improve treatment and prevention of opioid misuse and opioid use disorder and (2) enhance pain management. More information and periodic updates about the HEAL Initiative is available at: https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative.

Public Law 115-141, the Consolidated Appropriations Act of 2018 (signed on March 23, 2018) includes a requirement that grantees from for-profit applicant organizations must provide a 50% match and/or in-kind contribution of all federally awarded dollars under the grant award (direct costs, as well as facilities and administrative costs) for research related to opioid addiction, development of opioid alternatives, pain management and addiction treatment.

Applications are not being solicited at this time.

Please direct all inquiries to:

Shelley Su, Ph.D.
National Institute on Drug Abuse
301-402-3869
C3PO_R2D2@nih.gov