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The HEALing Communities Study will test the immediate impact of implementing an integrated set of evidence-based interventions across healthcare, behavioral health, justice, and other community-based settings to prevent and treat opioid misuse and Opioid Use Disorders (OUD) within highly affected communities. Highly affected communities of interest could include counties or cities within states that are burdened with higher than average rates of overdose mortality and opioid-related morbidity, and other complications.  Combined, all the communities participating in a single research site application must demonstrate having experienced at least 150 opioid related overdose fatalities (15% of these fatalities must be from rural communities) and a rate of 25 opioid related overdose fatalities per 100,000 persons or higher in the past year, based on the most recent complete year of data available.

The National Institute on Drug Abuse (NIDA), in partnership with the Substance Abuse and Mental Health Services Administration (SAMHSA) is soliciting cooperative agreement applications with the intention of ultimately funding up to three research sites to participate in the 'HEALing Communities Study': Developing and Testing an Integrated Approach to Address the Opioid Crisis.  The HEALing Communities Study will test the immediate impact of implementing an integrated set of evidence-based interventions across healthcare, behavioral health, justice, and other community-based settings to prevent and treat opioid misuse and Opioid Use Disorders (OUD) within highly affected communities.

The purpose of this Funding Opportunity Announcement (FOA) is to support intramural-extramural collaborations to develop and implement the use of 3D biofabricated tissue models as novel drug screening platforms and advance pre-clinical discovery and development of non-addictive treatments for nociception, opioid use disorder (OUD) and/or overdose. In particular, support during the UH2 phase is for the application of 3D biofabrication technologies to develop novel multicellular tissue constructs for drug screening by using human iPSC-derived cells representing sensory/pain neurons, brain regions, and other tissues involved in nociception, addiction and/or overdose, including tissue models of the blood-brain barrier (BBB). Support during the UH3 is for implementation of drug screens using the 3D tissue models developed during the UH2 phase. Please limit this field to a brief description of to page in length. Brevity is appreciated. This FOA is part of the of the NIHs 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

This funding opportunity announcement aims to support research that employs innovative scalable technologies to inventory, register and profile the cellular ensembles and/or cell-types that produce and/or respond to opioids. Emphasis is on approaches that enable high-throughput single-cell resolution mapping, anatomical characterization and/or molecular profiling of cells identified as primary sources of, or pharmacological targets of, opioids in the brain and/or whose changes in activity associate with opioid-related behaviors in rodents.

Despite significant scientific advancements made in substance use disorder research over the last century, the causes and consequences of drug use in later life remain poorly understood. The intent of this funding opportunity announcement is to support innovative research that examines aspects of marijuana and prescription opioid and benzodiazepine use in adults aged 50 and older. This FOA encourages research that examines the determinants of these types of drug use and/or characterizes the resulting neurobiological alterations, associated behaviors, and public health consequences. This initiative will focus on two distinct populations of older adults: individuals with earlier onset of drug use who are now entering this stage of adult development or individuals who initiate drug use after the age of 50. Applications are encouraged to utilize broad methodologies ranging from basic science, clinical, and epidemiological approaches. The insights gleaned from this initiative are critical to our understanding of the determinants of drug use in later life, as well as its consequences in the aging brain and on behavior. This knowledge may have the potential to identify risk factors and to guide clinical practices in older populations.

The purpose of this research is to identify, implement, and evaluate the use of effective strategies and tools for provider and patient use to taper and/or discontinue opioids, benzodiazepines, and other medications in which risk outweighs benefits to prevent falls, overdose, and other injuries among community dwelling older adults.

The purpose of this Funding Opportunity Announcement (FOA) is to encourage investigators to pursue translational activities and clinical trials to treat pain with innovative, targeted, and non-addictive diagnostic and/or therapeutic devices that improve patient outcomes and decrease or eliminate the need to prescribe opioids. Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, obtaining an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, as well as a subsequent small clinical trial (e.g., Early Feasibility Study). The clinical trial is expected to provide information about the device function or final design that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. This is a milestone-driven cooperative agreement program and will involve participation of NIH program staff in the development of the project plan and monitoring of research progress. This FOA will leverage Public-Private Partnership Programs (PPP) initiated under the NIH BRAIN Initiative, the Office of Strategic Coordination The Common Funds Stimulating Peripheral Activity to Relieve Conditions (SPARC) Program, and the HEAL Initiative. These programs include agreements (Memoranda of Understanding, MOU) with a number of device manufacturers willing to make such devices available, including devices and capabilities not yet market approved but appropriate for clinical research. In general, it is expected that the devices' existing safety and utility data will be sufficient to enable new IRB NSR or FDA IDE approval without the need for significant additional non-clinical data.

HIV-associated neurological disorders (HAND) persist in up to 50% of HIV-patients even when HIV replication is suppressed by combination antiretroviral therapy (cART), which transformed HIV/AIDS from a fatal illness into a chronically managed long-term condition. HIV does not infect neurons, but infects microglia and macrophages in the brain, causing HAND associated neuropathology. HAND epitomizes a series of disorders include Asymptomatic Neurocognitive Impairment (ANI), Mild Neurocognitive Disorder (MND), and HIV-Associated Dementia (HAD). These neurocognitive deficits interfere with psychomotor speed and coordination, diminishing memory and executive functions, and reduce quality of life in long-standing aviremic HIV-positive patients. These clinical challenges mandate research for a better understanding of HIV neuropathology; however, currently there are no effective approaches for HIV-infected live human brain studies or realistic HIV-infected animal models for HIV neuropathology. Proposed projects MUST include the following components. Applications which lack these three components will be considered non-responsive to the FOA and will not be reviewed. The major thrust of the project MUST involve exploitation of induced microglia and cerebral organoids generated from patient derived iPSC lines to better understand the molecular and cellular mechanisms of HIV-Associated Neurocognitive Disorder (HAND). At least one aim or sub-aim MUST also involve either 1. opioid, cannabinoid, methamphetamine, nicotinic, dopaminergic, or other signaling pathways relevant to addictive substance use, or 2. exposure to addictive substances, or 3. analysis of samples from patients that have used addictive substances or have SUDs.