NIH – HEAL Initiative: Preventing Opioid Use Disorder in Older Adolescents and Young Adults (ages 16–30) (UG3/UH3 Clinical Trial Required

December 17, 2018 by kjt5j@virginia.edu

As part of NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to the national opioid public health crisis, NIDA is launching the HEAL Preventing Opioid Misuse and Opioid Use Disorder in Older Adolescents and Young Adults (ages 16-30) initiative.  The HEAL prevention initiative will consist of up to ten research projects and one coordinating center. This prevention initiative is designed to solicit research to develop, adapt and test interventions and strategies to prevent initiation of opioid misuse and development of Opioid Use Disorder (OUD) in at-risk older adolescents and young adults (ages 16-30). Of priority are studies that target older adolescents and young adults in health care settings (including emergency departments, surgical, orthopedic and other specialty care, dental care, primary care, urgent care, HIV/STI and reproductive health clinics, prenatal clinics, primary care, federally qualified health centers, school-based health centers, military medicine settings, and occupational health settings); justice settings (including criminal justice, juvenile justice, as well as child welfare and other systems that intersect with the justice system); and, other systems and settings opportune for accessing and engaging at-risk older adolescents and young adults.

Background

An estimated 11.4 million people misused opioids in 2017, of which 11.1 million misused prescription opioid analgesics. Opioid drugs, including opioid analgesics, heroin and illicit synthetics, accounted for more than 60% of overdoses in 2016. There is need to develop preventive strategies that can decrease the incidence and prevalence of opioid misuse and OUD, particularly in at-risk populations. This initiative focuses on older adolescents and young adults (ages 16-30), two of the populations at highest risk for initiation and misuse of opioids, OUD and related consequences, including overdose fatalities.

Currently, evidence-based interventions exist to prevent substance use broadly, that predominantly target children and adolescents. However, there is a gap in the evidence for interventions and strategies to prevent non-medical use of opioids and OUD in the transition from adolescence to young adulthood. The urgency of the opioid crisis calls for research to produce evidence based interventions and strategies to prevent older adolescents and young adults from initiating non-medical use of opioids, escalating from initiation to misuse, and escalating from misuse to OUD.

Objectives and Scope

This funding opportunity is being offered as part of the NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative will bolster research across NIH to (1) improve treatment for opioid misuse and addiction and (2) enhance pain management. More information 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 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.

Matching Requirement: A grantee from a for-profit organization funded under this funding opportunity announcement must match funds or provide documented in-kind contributions at a rate of not less than 50% of the total-Federally awarded amount, as stipulated by Public Law 115-141, the Consolidated Appropriations Act of 2018.The applicant will be required to demonstrate that matching funds and/or in-kind contributions are committed or available at the time of, and for the duration of, the award. Applications must identify the source and amount of funds proposed to meet the matching requirement and how the value for in-kind contributions was determined. All matching funds and/or in-kind contributions must be used for the portion of allowable project costs not paid by Federal funds under the grant award.  NIH will not be the recipient, nor serve as a pass-through entity, of any such matching funds and/or in-kind contributions required under this announcement.  See 45 CFR 75.306 for additional details.

For this FOA, NIDA is seeking applications for research studies to be part of a cooperative agreement that will be comprised of two components: 1) UG3/UH3 research projects solicited under this RFA, and 2) a single coordinating center, which will provide logistical and scientific support related to data collection and management, implementation design and methodology consultation and economic evaluation, to be solicited under a separate FOA.  The objectives of this research cooperative are to support rigorous research to: 1) develop strategies to identify, reach, and engage older adolescent and young adult populations at risk for opioid misuse and OUD in prevention interventions and services, 2) develop and adapt interventions and strategies to prevent initiation of opioid misuse, escalation from initiation to misuse, and escalation from misuse to OUD, 3) test the effect of prevention strategies and interventions on initiation of opioid use, opioid misuse, OUD and other opioid related outcomes, 4) develop and test strategies to facilitate implementation and sustainability of prevention interventions and strategies in health care, justice and other systems and settings opportune for accessing and engaging at-risk older adolescents and young adults, and, 5) conduct an economic evaluation (e.g., to quantify programmatic costs and cost-effectiveness of interventions and strategies). Research projects funded under the cooperative are expected to address all five objectives. Of priority are studies that target older adolescents and young adults in health care settings (including emergency departments, surgical, orthopedic and other specialty care, dental care, primary care, urgent care, HIV/STI and reproductive health clinics, prenatal clinics, federally qualified health centers, school-based health centers, military medicine settings, and occupational health settings); justice settings (including criminal justice, juvenile justice, as well as child welfare and other systems that intersect with the justice system); and other systems and settings.

For this FOA, opioids include prescription opioids and illicit opioids, such as heroin and illicitly made fentanyl (and related analogs). For the purpose of this announcement, prevention is defined as interventions that occur prior to the onset of OUD and are intended to prevent or reduce risk for OUD. OUD refers to the clinical diagnosis defined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). This FOA seeks research that addresses the appropriate level of risk for the target population and setting (universal, selective, indicated, as defined in the IOM 2009 report). Given the priority on high-risk older adolescents and young adults, selective interventions (targeted to individuals or a subgroup of the population whose risk is significantly higher than average), indicated interventions (targeted to high-risk individuals who are identified as having detectable signs and symptoms but not at the level of a disorder) as well as tiered interventions (that include two or more levels) are of particular interest for this FOA (IOM 2009).

Older adolescence and young adulthood are two distinct and important life stages that can involve significant transitions, change and challenges, particularly for vulnerable and at-risk groups. For some, these periods can involve transition to greater autonomy and independence, which might include participation in the workforce, the military, or entry into college or vocational training. Others might be aging out of the juvenile justice or foster care systems or re-entering the community after being institutionalized. This time of increased decision-making and autonomy is also a period of increased risk for substance use, including opioid misuse and development of OUD, particularly for already vulnerable populations. Identifying, accessing, engaging and retaining at-risk older adolescents and young adults in prevention programs can be particularly challenging, as they may neither be working nor in school/college; they may be disconnected from parents/caregivers, family and other social supports; and/or, they may have an unstable living situation. It is important that prevention programs include strategies to identify, engage and intervene with at-risk, vulnerable groups in an array of settings and with a variety of intervention modalities and strategies.

While the prevention field has made significant progress leading to the identification of effective approaches and strategies to prevent substance use and substance use disorders in children and adolescents, research is needed to develop more effective strategies to prevent opioid misuse and OUD for emerging and young adults. The opioid epidemic presents a potentially unique challenge because of the role that prescription and non-prescription drugs play in treating pain and other medical conditions. This FOA encourages research that takes advantage of existing evidence-based prevention strategies, interventions or models that might be applicable and translatable for preventing opioid misuse and OUD, for example from the drug abuse field broadly, alcohol, suicide, mental health or other fields. Interventions proposed should be theory-based, and the theory and rationale behind the interventions proposed should be clearly described. In addition, interventions proposed should be developmentally appropriate for the target age group of the study, and developmental relevance and tailoring should be clearly explained.

Research Projects

The expectation is that the suite of research studies funded under this FOA will yield efficacious/effective interventions and strategies to prevent initiation of opioid misuse and development of OUD in older adolescents and young adults that will be adopted in health care systems, justice systems and other systems and settings that may be opportune places to reach high risk populations and deliver prevention interventions. Studies proposed under this FOA may span the range of efficacy, effectiveness, and implementation research, and/or propose hybrid study designs relevant to the intervention and research questions proposed. Of interest are research studies designed to test whether an intervention engages a proximal target or specified mechanism presumed to underlie the intervention’s effect on a distal outcome. Investigators are encouraged to test hypotheses regarding moderators, mediators and mechanisms of action of interventions. Applications proposing effectiveness trials are encouraged to address the use of scalable and sustainable approaches to improve the uptake of promising interventions.  Study designs proposed should be rigorous and appropriate for addressing the research questions proposed within the project timeline. Applicants are encouraged to leverage existing NIDA or NIH-funded networks as platforms for research, to facilitate recruitment and conduct the research.

Specific Topics of Research Interest

This FOA encourages, but is not limited to, research applications that address the following areas of interest:

Development of theory-based prevention interventions that can be integrated into health care, justice, or other human service systems and settings for high-risk individuals, including interventions and strategies that address the unique needs of racial/ethnic minority populations and underserved communities. This includes including adaptation of existing evidence-based interventions to address opioids.

Studies to test models of integrating existing substance use prevention and other risk reduction modalities (e.g., motivational interviewing, skill building, enabling of prosocial relationships) into health care, justice or other human service systems.

Implementation of evidence based substance use prevention interventions that incorporate technology, such as mobile health and telehealth delivery or models of consultation, to facilitate linkage and delivery in settings such as primary care and other settings where delivery of prevention interventions is novel.

Research on interventions designed to address known risk factors for risk behaviors such as sensation seeking, impulsivity or others.

Studies to develop and test prevention interventions designed to prevent misuse of opioids and development of OUD in older adolescents and young adults at risk for and who have mental disorders (e.g., depression, anxiety, post-traumatic stress disorder, serious mental illness, suicide ideation and behaviors).

Research that utilizes risk-profiles in dental, orthopedic, surgical, pain, primary care, or other clinical settings to facilitate case identification, active referral and linkage to prevention interventions and or consultation models.  For example, using electronic health records and service delivery data collected during routine care to modify opioid prescribing, offer patient education, or provide enhanced pain strategies for people whose alcohol or other drug use may indicate that they are at risk for opioid misuse.

Development and testing of public awareness and communication strategies as part of a broader intervention or strategy targeted to high risk populations in health care, justice, community and other settings, delivered through mobile technology, social media and other novel platforms.

Research on novel funding strategies to implement and sustain prevention interventions, such as Medicaid waivers, reimbursement for telehealth service delivery and consultation.

Research to address system fragmentation and gaps for persons transitioning from pediatric or adolescent medicine practices to adult medicine practices or for persons in specialty settings or social services systems who need linkage to health/behavioral health and prevention services.

Testing of strategies to implement preventive interventions in ways that overcome stigma related to substance use and its consequences, such as discrimination based on substance using behavior. This might include incorporation of content and activities to reduce self-stigma on the part of participant populations, stigma in delivery of basic services to substance users (e.g., discriminatory channels for service; treatment by reception, billing and other non-service provider staff).

This FOA is not focused on research to address general health or global functioning.

Organization of the Cooperative

The cooperative will include up to ten research projects, one Coordinating Center, a Steering Committee (SC), a SC chairperson, one or more Science Officers from NIDA and/or other Institutes, and NIDA and/or other Institute Program Officers.

Special Considerations

Points to Consider Regarding Tobacco Industry Funding of NIDA Applicants: The National Advisory Council on Drug Abuse (NACDA) encourages NIDA and its grantees to consider the points it has set forth with regard to existing or prospective sponsored research agreements with tobacco companies or their related entities and the impact of acceptance of tobacco industry funding on NIDA’s credibility and reputation within the scientific community. Please see (http://www.drugabuse.gov/about-nida/advisory-boards-groups/national-advisory-council-drug-abuse-nacda/council-statements/points-to-consider-regarding-) for details.

National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects:  The National Advisory Council on Drug Abuse (NACDA) recognizes the importance of research involving the administration of drugs with abuse potential, and dependence or addiction liability, to human subjects.   Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects.  The guidelines are available on NIDA’s Web site at  http://www.drugabuse.gov/funding/clinical-research/nacda-guidelines-administration-drugs-to-human-subjects.

Data Harmonization for Substance Abuse and Addiction via the PhenX Toolkit:  NIDA strongly encourages investigators involved in human-subjects studies to employ a common set of tools and resources that will promote the collection of comparable data across studies and to do so by incorporating the measures from the Core and Specialty collections, which are available in the Substance Abuse and Addiction Collection of the PhenX Toolkit (www.phenxtoolkit.org).  Please see NOT-DA-12-008 (https://grants.nih.gov/grants/guide/notice-files/NOT-DA-12-008.html) for further details.

Methodological and Statistical Resources:  Applicants are encouraged to employ the strongest prevention study designs and analytic methods. For guidance on state of the art study designs, methods and analytic techniques please visit these resources developed by NIH on Training in Prevention Methods ResearchResources for Researchers and GRTs.

Deadline:  March 13, 2019 (letters of intent due 30 days prior to deadline)

URL:  https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-19-035.html

Filed Under: Funding Opportunities