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.
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.
This study is part of the 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.
With this FOA, NIDA seeks applications for a Coordinating Center to facilitate cross-site activities and provide centralized support for projects funded under the NIDA HEAL Preventing Opioid Use Disorder in Older Adolescents and Young Adults (ages 16-30) initiative. 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) economic evaluation (e.g., to quantify programmatic costs and cost-effectiveness of interventions and strategies). Research projects funded via RFA-DA-19-035are expected to address each of these objectives.
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).
The Coordinating Center will be funded under a cooperative agreement and will work collaboratively with NIH and the investigators associated with the individual research projects. The Coordinating Center will facilitate activities in the areas of: coordination and communication, data collection and management, implementation design and methodology consultation, and economic evaluation. The Coordinating Center will be a participant on the cooperative Steering Committee (to include research project PIs and Federal Staff) which will manage the overall direction of the collaborative. The Coordinating Center also will facilitate activities of the cooperative internal working groups, which will include project PIs, their staff, collaborators and Federal Staff. Coordinating Center investigators may also participate in these groups, as appropriate. Further details on the roles and responsibilities of the Coordinating Center are described in Section IV.2 of this FOA.
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.
A Steering Committee will include at a minimum a) a representative from each research project, b) a NIDA Project Scientist(s), a NIDA/NIH Program Officer(s), and could include select key leaders/stakeholders from systems or settings named as key personnel in the research project applications. NIDA will appoint one Steering Committee Chairperson with relevant expertise to coordinate the activities of the Steering Committee.
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 and most innovative 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 Research, Resources for Researchers and GRTs.
Deadline: March 13, 2019 (letters of intent due 30 days prior to deadline)
Filed Under: Funding Opportunities