NIH – Emergency Award HEAL Initiative: Optimizing Existing Evidence-Based Multi-Component Service Delivery Interventions for People with Opioid Use Disorder, Co-Occurring Conditions, and/or Suicide Risk (R01 Clinical Trials Optional)

January 28, 2022 by


NIMH is issuing this FOA in response to the declared public health emergency issued by the Secretary, HHS. See “Determination that a Public Health Emergency Exists Nationwide as the Result of the Opioid Crisis” as renewed in “Renewal of the Determination that a Public Health Emergency Exists Nationwide as the Result of the Continued Consequences of the Opioid Crisis“.

In April 2018, the National Institutes of Health (NIH) launched 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. More information about the HEAL Initiative is available at:

In response to this initiative, the National Institute of Mental Health (NIMH), in partnership with other NIH Institutes, Centers, and Offices, invites research that will optimize existing evidence-based multi-component service delivery interventions for people with opioid use disorder (OUD) and co-occurring conditions, to include mental disorders and/or suicide risk. For interventions without prior evidence of clinical effectiveness see RFA-MH-22-176. The purpose of the initiative is to support studies that will test the relative contribution of constituent components to overall effectiveness of existing evidence-based service delivery interventions. This research will streamline service packages so they only include components that drive clinical improvements for complex conditions. Should the primary hypotheses be supported, the multi-component service delivery intervention will be optimized for uptake and implementation in community practice settings.


The HEAL Multidisciplinary Working Group (MDWG) called for research that seeks to improve the provision of care for people with common co-occurring conditions associated with the opioid crisis (e.g., people with mental health disorders, suicide risk, alcohol misuse/alcohol use disorder, chronic pain, and/or other substance use disorders).

Results from national surveys and other recent sources demonstrate that rates of co-occurring conditions are high. For example, among the millions of people with opioid use disorder (OUD), 27% have a serious mental illness, 64% have any mental illness, and approximately 11% to 26% have alcohol use disorder or another substance use disorder. Among those whose deaths are associated with opioid overdose (47,600 deaths in 2017 alone), up to 30% may be due to suicide. And, nonfatal overdoses involving opioids are associated with elevated suicide risk. Moreover, 16% of Americans who have mental health disorders receive over half of all opioids prescribed in the United States.

Wide variation in outcomes exists for multi-component service delivery interventions. Some interventions are implemented in practice and used to address problems for which there is little evidence of effectiveness (e.g., Screening Brief Intervention and Referral to Treatment (SBIRT); for depression or for OUD). Other multi-component interventions (e.g., the collaborative care model) are supported by robust clinical trial evidence. That robust evidence is often generated using trial designs like parallel arm or stepped wedge.

Trial designs like parallel arm and stepped wedge yield high quality evidence to support a decision to implement a service delivery intervention as a bundled package. However, these designs often offer limited information about the relative contribution of intervention components and include limited information about how to sequence treatments for patients with comorbidities. Comparative effectiveness trials are not necessarily powered or designed to detect the effects of constituent components of multi-component service delivery interventions. Findings from these trials, therefore, offer little direction to the practice community about how to identify the most important components and about how to optimize those components for the practice setting.

Key Dates:

Open Date (Earliest Submission Date): February 18, 2022
Letter of Intent Due Date(s): 02/18/2022
Applications Due: March 18, 2022

URL for more information:

Filed Under: Funding Opportunities