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MiamiOH OARS

PAR-18-427: First in Human and Early Stage Clinical Trials of Novel Investigational Dru... - 0 views

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    The purpose of this Funding Opportunity Announcement (FOA) is to encourage cooperative agreement applications to support early stage clinical trials of novel mechanism of action, investigational drugs or drug candidates for the treatment of psychiatric disorders in areas of unmet medical need. The FOA will support milestone-driven early stage trials in pediatric and adult populations. First in human (FIH) and Phase Ib studies of novel Agents must assess target engagement (brain exposure), pharmacological effects, safety, and tolerability to assess feasibility for Phase II/proof of concept (PoC) studies in psychiatric disorders. Phase II/PoC studies must evaluate the drug's impact on clinically relevant physiological systems (functional measures) and clinical indicators of effect. The FOA also supports FIH and early feasibility studies (EFS) of novel devices to evaluate target engagement, safety, tolerability, and efficacy. The overall objective is to facilitate rapid collection of data to "de-risk" novel mechanism of action investigational drugs, novel drugs for use in pediatric populations with psychiatric disorders, and devices or combination treatments in order to attract private funding for further clinical development as FDA-approved treatments.
MiamiOH OARS

PAR-18-252: Image-guided Drug Delivery (R01 Clinical Trial Optional) - 0 views

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    This Funding Opportunity Announcement (FOA) will support innovative research projects that are focused on image-guided drug delivery (IGDD), including real-time image guidance, monitoring, quantitative in vivo characterizations and validation of delivery and response. It will support research in development of integrated imaging-based systems for delivery of drugs or biologics in cancer and other diseases, quantitative imaging assays of drug delivery, and early intervention.
MiamiOH OARS

Accelerating the Pace of Drug Abuse Research Using Existing Data (R01 Clinical Trial Op... - 0 views

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    The purpose of this Funding Opportunity Announcement (FOA) is to invite applications proposing the innovative analysis of existing social science, behavioral, administrative, and neuroimaging data to study the etiology and epidemiology of drug using behaviors (defined as alcohol, tobacco, prescription and other drug) and related disorders, prevention of drug use and HIV, and health service utilization. This FOA encourages the analyses of public use and other extant community-based or clinical datasets to their full potential in order to increase our knowledge of etiology, trajectories of drug using behaviors and their consequences including morbidity and mortality, risk and resilience in the development of psychopathology, strategies to guide the development, testing, implementation, and delivery of high quality, effective and efficient services for the prevention and treatment of drug abuse and HIV.
MiamiOH OARS

Neuroscience Research on Drug Abuse (R01 Clinical Trial Optional) - 0 views

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    Long-term misuse and chronic exposure to abused substances can produce widespread changes in brain structure and function. Although much progress has been made, additional research is still needed to identify the neurobiological changes that result from substance use, and how these changes contribute to substance use disorders. The overarching goals of the research areas described in this FOA are to understand the neurobiological mechanisms underlying substance use disorders, with special emphasis on identifying changes and neuroadaptations that occur during dependence, withdrawal, and relapse to chronic substance use. An understanding of the basic mechanisms underlying substance use disorders can help to identify targets for prevention and treatment interventions. Research utilizing basic, translational, or clinical approaches is appropriate.
MiamiOH OARS

Prescription Drug Abuse (R21 Clinical Trial Optional) - 0 views

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    This Funding Opportunity Announcement (FOA) encourages applicants to develop innovative research applications on prescription drug abuse, including research to examine the factors contributing to prescription drug abuse; to characterize the adverse medical, mental health and social consequences associated with prescription drug abuse; and to develop effective prevention and service delivery approaches and behavioral and pharmacological treatments. Applications to address these issues are encouraged across a broad range of methodological approaches including basic science, clinical, epidemiological, and health services research to define the extent of the problem of prescription drug abuse, to characterize this problem in terms of classes of drugs abused and combinations of drug types, etiology of abuse, and populations most affected (including analyses by age group, race/ethnicity, gender, and psychiatric symptomatology). Studies on individual- and patient-level factors, prescriber factors, and/or health system factors are encouraged, as are studies on all classes of prescription drugs with high abuse liability, including analgesics, stimulants, sedative/hypnotics and anxiolytics. Researchers are further encouraged to study the relationship between the prescription medication, the indication for which the medication was prescribed (e.g., pain, sleep disorder, anxiety disorder, obesity), and the environmental and individual factors contributing to abuse.
MiamiOH OARS

Gang Resistance Education And Training (G.R.E.A.T.) Program - Training and Technical As... - 0 views

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    The purpose of this grant is to continue to provide G.R. E.A.T. Instructor Certifications to Central American Officers plus overall management and coordination of the Program, including scheduling of trainers and training; regular review, revision, and updating of curricula and training processes; publication and production of materials and resources needed for training and for instructors in the field; maintenance and enhancement of a dual-language G.R.E.A.T. Web site; continued development of program curricula and materials to improve accessibility for Central American audiences; and monitoring and evaluation of Program implementation to ensure fidelity to the Program design and effective delivery of services.
MiamiOH OARS

Exploiting HIV and/or Host Genomic Information to Understand HIV Compartments or Reacti... - 0 views

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    This initiative will support exploratory projects that exploit HIV or host genomic or nucleomic information to understand HIV latency in individuals with substance use disorders (SUDs).
MiamiOH OARS

Drug Early Warning Signals from High Risk Populations - 0 views

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    The Office of National Drug Control Policy (ONDCP), Executive Office of the President, is seeking applications from public nonprofit institutions/organizations (includes institutions of higher education and hospitals) to perform research and analysis of data to inform drug policy. This project seeks to further refine a methodology for obtaining drug early warning indicators from expanded testing of urine samples that were previously collected and tested as part of an existing drug test protocol. This method was initially developed using local criminal justice populations - including persons in pre-trial or lock-up, parolees or probationers, and drug court participants. In addition, this method was also tested in two trauma units, with promising results. This project will use similar methodology in criminal justice, health care, and other venues, to include opioid treatment admissions, trauma units or emergency departments, and criminal justice programs such as parole or probation, where biological samples are often collected from clients.
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