NIH – Optimizing Multi-Component Service Delivery Interventions for People with Opioid Use Disorder, Co-Occurring Conditions, and/or Suicide Risk (R01 Clinical Trials Optional)

January 14, 2021 by


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. 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 multi-component service delivery interventions for people with opioid use disorder (OUD) and co-occurring conditions, to include mental disorders and/or suicide risk. The purpose of the initiative is to support studies that will (1) test the overall effectiveness of multi-component interventions for OUD and co-occurring conditions and (2) examine the relative contribution of constituent components to overall effectiveness. This research will streamline service packages so they only include components that drive clinical improvements for complex conditions.

The content of this RFA complements research stemming from RFA-DA-21-029 and RFA-DA-21-030.


In August 2019 and again in March 2020, 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 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, the 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 multicomponent 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:

Posted Date: January 11, 2021
Open Date (Earliest Submission Date): February 18, 2021
Letter of Intent Due Date(s): February 18, 2021
Application Due Date(s): March 18, 2021

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Filed Under: Funding Opportunities