Background

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.

Research Objectives

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.

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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:

• Measure use of other substances and employ measures as part of NIMH’s set of common data elements per NOT-MH-20-067, given high rates of co-occurring problems in this target population.
• Include a range of outcomes and mediators (beyond the primary OUD care pathway outcome), such as decreases in victimization, improvement in PTSD symptoms, engagement in services, improvements in social determinants of health (SDOH)s, improvements in other health conditions associated with victimization (e.g., sleep, headaches, back pain, anxiety)
• Utilize efficient and innovative designs (e.g., SMART or factorial designs) to test models of service delivery and yield actionable findings to the practice community.
• Study factors associated with scalability, sustainability, equity, cost, patient and stakeholder engagement, and translation to practice.

Research priority areas include, but are not limited to:

• Tailoring and testing implementation strategies to screen for PTSD and if indicated, integrate evidence-based interventions for PTSD into existing OUD prevention or treatment services/interventions.
• Research that tests the feasibility and/or effectiveness of integrating opioid misuse/OUD screening and SUD prevention services into victim service organizations.
• Studies that tailor and test the affordability and integration of evidence-based services in organizations and systems that are best able to provide services for people with co-occurring OUD and PTSD.
• Trials testing patient and client engagement strategies (e.g., strategies to improve access, continuity, equity, and outcomes of care), with specific, data-supported, and testable hypotheses about SDOHs, state/federal policies, clearly operationalized factors associated with stigma, other community-level constructs as mechanisms of change associated with OUD and PTSD care.
• Studies that test sequencing of PTSD and OUD treatment – comparing behavioral health outcomes between sequential treatment to integration of OUD and PTSD treatment.
• Research that examines the effect of integrating evidence-based violence prevention interventions into opioid misuse preventative interventions or standard OUD care, with a dual focus of preventing OUD or improving OUD outcomes and reducing subsequent exposures to violence.
• Testing the sustainable use of peer navigators, community health workers, or victim advocates in facilitating linkages for individuals who might benefit from victim services, mental health and OUD prevention or treatment services.

Special Considerations:

• The project team should include an investigator who has expertise in violence and victimization research.
• Budget requests should reflect costs that are necessary and reasonable to complete the work described in the application.
• Rather than the creation of new measurement tools, applicants are strongly encouraged to use existing psychometrically validated measures where possible.
• Letters of support from all treatment and victim service organizations should be included, even for applications intending to further develop those relationships in an R61 phase.

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).