August 3, 2022
RFA-DA-23-053 - HEAL Initiative: Translating Research to Practice to End the Overdose Crisis (R61/R33 - Clinical Trial Optional)
RFA-DA-23-054 - HEAL Initiative: Translating Research to Practice to End the Overdose Crisis (Parent R33 - Clinical Trial Optional)
PAS-22-206 - HEAL Initiative: Career Development Awards in Implementation Science for Substance Use Prevention and Treatment (K01 - Clinical Trial Required)
PAS-22-207 - HEAL Initiative: Career Development Awards in Implementation Science for Substance Use Prevention and Treatment (K23 - Clinical Trial Required)
NOT-MH-20-067 - Notice Announcing the National Institute of Mental Health (NIMH) Expectations for Collection of Common Data Elements
NOT-MH-22-095 - Notice of Special Interest: NIMH Priorities on Research on Aggression and Violence Against Others
National Institute on Drug Abuse (NIDA)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Mental Health (NIMH)
National Center for Complementary and Integrative Health (NCCIH)
All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.
Office of Behavioral and Social Sciences Research (OBSSR)
The NIH HEAL initiative aims to speed the development and implementation of scientific solutions to the national opioid public health crisis by bolstering research across NIH to (1) improve treatment for opioid misuse and addiction and (2) enhance pain management. More information and periodic updates about the HEAL Initiative are available at: https://heal.nih.gov/.
Prior research demonstrates a substantial association between exposure to violence and opioid use. The majority of people diagnosed with substance use disorders have been exposed to violence; and among those with injection drug use, over a quarter have experienced a new episode of violence in the past month. Victimization can be linked to opioid use through a variety of pathways. It can result in physical pain and mental distress leading to substance use initiation and escalation. Victimization can also occur as a consequence of drug seeking behavior. Social and structural determinants of health, such as housing insecurity and justice-system involvement, also increase individual risk for opioid use and exposure to violence.
Despite the strength of the association between exposure to violence and substance misuse and disorders, research about the extent to which and the ways in which victimization history affects initiation of opioid misuse, escalation to opioid use disorder (OUD), engagement in OUD prevention or treatment services, retention in services, and OUD recovery is limited. Victimization experiences may result in PTSD, characterized by intrusive memories, avoidance behaviors, negative cognitions and mood, and changes in physical and emotional reactions. Over a third of people diagnosed with OUD are estimated to have symptomss consistent with post-traumatic stress disorder (PTSD). Although a PTSD diagnosis does not seem to predict poorer treatment retention on medications for opioid use disorder (MOUDs), concurrent treatment of PTSD and OUD has been shown to dramatically improve retention on MOUDs. Likewise, research with patients in OUD treatment has shown that exposure to traumatic events and a worsening of PTSD symptoms during the course of OUD treatment are associated with increased risk of treatment interruption.
The proposed initiative seeks to test innovative models of service delivery to improve substance use and mental health outcomes for individuals who have actionable needs following exposure to violence. Specifically, this initiative would support awards to test care pathways that either: 1) provide opioid misuse and OUD screening, prevention and treatment referral or services to victims of violence in victim service settings; or 2) provide PTSD screening and treatment or intimate partner violence (IPV) screening and services for individuals receiving treatment or prevention services for opioid misuse or OUD. Studies must include OUD relevant outcomes, but may propose interventions to treat or prevent stimulant use disorder in combination with OUD. Intervention studies supported through this initiative can be targeted at the individual, provider, and/or organizational level. Interventions can be proposed for adolescent, emerging adult and/or adult populations. Hybrid implementation-effectiveness trials are preferred and should be proposed as appropriate to the intervention and research questions posed. Validated screening measures for exposure to violence, substance use and PTSD from the PhenX Toolkit should be used when appropriate to the study design.
A critical component for this initiative is developing partnerships between victim service and treatment provider organizations and all applications must develop these partnerships. In addition, high priority applications will:
Research priority areas include, but are not limited to:
National Institute of Mental Health (NIMH) Specific Language
The National Institute of Mental Health (NIMH) is interested in applications relevant to priorities described in this NOSI, in NOT-MH-22-095: Notice of Special Interest: NIMH Priorities on Research on Aggression and Violence Against Others, and that support the NIMH Strategic Plan for Research Goal #4. NIMH is committed to supporting research that reduces disparities and advances equity in mental health treatment, services, and outcomes.
All applications that propose clinical trials should follow the NIMH’s experimental therapeutics approach to intervention development and testing (see https://www.nimh.nih.gov/funding/opportunities-announcements/clinical-trials-foas/index.shtml). That is, the scope of work must include specification of targets/mechanisms and assessment of intervention induced changes in the presumed targets/mechanisms that are hypothesized to account for the intervention’s outcomes. In this manner, the results of the trial will advance knowledge regarding therapeutic change mechanisms and be informative regardless of trial outcomes (e.g., in the event of negative results, information about whether the intervention was successful at engaging its targets can facilitate interpretation).
NIMH encourages a deployment-focused model of intervention and services design and testing that takes into account the perspective of relevant stakeholders (e.g., service users, providers, administrators, payers) and the key characteristics of the settings (e.g., resources, including workforce capacity; existing clinical workflows) that are intended to implement optimized mental health interventions. This attention to end-user perspectives and characteristics of intended clinical and/or community practice settings is intended to ensure: the resultant interventions and service delivery strategies are acceptable to consumers and providers, the approaches are feasible and scalable in the settings where individuals are served, and the research results will have utility for end users.
NIMH encourages research to implement, scale, and sustain effective preventive, therapeutic, and services interventions that focuses on practice-relevant questions. Accordingly, collaborations between academic researchers and clinical or community practice partners or networks are strongly encouraged. When possible, studies should capitalize on existing infrastructure (e.g., practice-based research networks such as the NIMH-sponsored Mental Health Research Network (MHRN), electronic medical records, administrative data bases, patient registries, institutions with Clinical and Translational Science Awards) to increase the efficiency of participant recruitment (i.e., more rapid identification and enrollment) and to facilitate the collection of moderator data (e.g., clinical characteristics, biomarkers), longer-term follow-up data, and broader, stakeholder-relevant outcomes (e.g., mental health and general health care utilization, value and efficiency of intervention approaches).
Application and Submission Information
Applicants must select the IC and associated FOA to use for submission of an application in response to the NOSI. The selection must align with the IC requirements listed in order to be considered responsive to that FOA. Non-responsive applications will be withdrawn from consideration for this initiative.This notice applies to due dates on or after October 12, 2022 and subsequent receipt dates through July 13, 2025.
Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcement through the expiration date of this notice.
All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:
Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.
National Institute on Drug Abuse(NIDA)