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This Funding Opportunity Announcement (FOA) encourages R21 grant applications to conduct rigorous health services and economic research to maximize the delivery of efficient, high-quality drug, tobacco, and alcohol prevention, treatment, and recovery support services. Examples of such research include: (1) clinical quality improvement; (2) quality improvement in services organization and management; (3) implementation research; (4) economic and cost studies; and (5) development or improvement of research methodology, analytic approaches, and measurement instrumentation used in the study of drug, alcohol, and tobacco prevention, treatment, and recovery services

The purpose of this FOA is to provide support for applications that focus on data replication and the scalability of novel, targeted addiction treatments. Consistent with an experimental therapeutics approach, studies that would fall under the R33 (Phase II) would include studies with theory-derived targets (based on putative mechanisms of ATOD) and clearly defined hypotheses about how the proposed treatment directed at changing the target relates to clinical outcomes. In addition, studies that include preliminary efficacy with respect to target engagement and validation (i.e., data to establish the relation between target and symptom reduction and functional outcomes) are essential to the Phase II arm (R33). Studies of novel treatments include, but are not limited to behavioral, pharmacological, biologics-based, cognitive, device-based, interpersonal, physiological, or combined approaches. This FOA provides support for replication studies of addiction treatment across 2 or more settings. Specifically, this phase will focus on clinical trials that apply the target in a treatment setting (testing, refinement, and/or adaptation) to evaluate the efficacy and replicability of larger trials. Ultimately, the goal of this FOA is to replicate findings of mechanisms and processes underlying treatments or replication of strategies into novel intervention approaches that can be efficiently tested and replicated for their promise to address substance use disorder outcomes. Furthermore, these studies build on data that have been demonstrated with sufficient signal of target engagement from an analogous R21-like study to justify the proposed R33 trials.

Studies of novel treatments include, but are not limited to behavioral, pharmacological, physiological, learning- and device-based treatment approaches. This FOA provides support for up to two years (Phase I; R21) for protocol development, target identification and studies to confirm target engagement (i.e., link targets with tangible outcomes); followed by up to 3 years of support (Phase II; R33) for replication studies of addiction treatment across 2 or more settings. Specifically, this latter phase will focus on clinical trials that apply the target in a treatment setting (development, refinement, and/or adaptation) to evaluate the feasibility of conducting a larger trial.

The purpose of this initiative is to: accelerate innovative drug and device discovery; develop pharmacologic and neuromodulatory tools for basic and clinical research on mental disorders, substance use disorders (SUDs) or alcohol addiction; develop and validate tools (pharmacologic or neurostimulation) in support of experimental therapeutic studies of innovative new candidates for mental disorders; and support early stage human studies to rapidly assess the safety, tolerability, and pharmacodynamics of promising drug candidates/devices and new indications for novel Investigational New Drug (IND)-ready agents or Pre-Market Approval (PMA)-ready devices for the treatment of mental disorders, SUDs or alcohol addiction. This FOA encourages applications to advance the discovery, preclinical development, and proof of concept (PoC) testing of new, rationally based candidate agents and neurostimulation approaches to treat mental disorders or SUDs or alcohol addiction, and to develop novel ligands and circuit-engagement devices as tools to further characterize existing or to validate new drug/device targets. Partnerships between academia and industry are strongly encouraged.

This funding opportunity announcement (FOA) seeks to facilitate the entry of both newly independent and early career investigators to the area of drug abuse research on HIV/AIDS. This FOA, AIDS-Science Track Award for Research Transition (A-START), encourages Small Research Grant (R03) applications to support research projects on drug abuse and HIV/AIDS that can be carried out in a short period of time with limited resources. Applications under this FOA are welcomed from all areas of HIV/AIDS research that NIDA supports.

The purpose of the Academic Research Enhancement Award (AREA) program is to stimulate research in educational institutions that provide baccalaureate or advanced degrees for a significant number of the Nation's research scientists, but that have not been major recipients of NIH support. AREA grants create opportunities for scientists and institutions otherwise unlikely to participate extensively in NIH research programs to contribute to the Nation's biomedical and behavioral research effort. AREA grants are intended to support small-scale research projects proposed by faculty members of eligible, domestic institutions, to expose undergraduate and/or graduate students to meritorious research projects, and to strengthen the research environment of the applicant institution.   

There is a devastating opioid use and overdose crisis in the United States. It has been reported that approximately 25.5 million adults suffer pain and opioids that are often prescribed for their treatment can lead to opioid misuse and dependence. It has also been reported that more than 2 million Americans have OUDs and many started their addiction with prescribed opioids. One of the most devastating consequences of opioid misuse is opioid overdose, which can produce respiratory depression and death. Drug overdose is the leading cause of accidental death in the US, with an estimation of 60,000 deaths in 2016; 20,101 overdose deaths related to prescription pain relievers, and 12,990 overdose deaths related to heroin.

The Brain Research through Advancing Innovative Neurotechnologies (BRAIN) InitiativeSM is aimed at revolutionizing our understanding of the human brain. By accelerating the development and application of innovative technologies, researchers will be able to produce a new dynamic picture of the brain that, for the first time, will show how individual cells and complex neural circuits interact in both time and space. It is expected that the application of these new tools and technologies will ultimately lead to new ways to treat, cure, and even prevent brain disorders.

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) invites applications to evaluate the cumulative and progressive effects on brain structure and cognitive/behavioral function of combined HIV infection and alcohol abuse. This project has recruited and longitudinally tracked a large cohort of individuals with HIV infection, or alcohol abuse, or the comorbid condition. As members of this cohort are growing older and living well longer due to antiretroviral medications, this project is well suited to address several questions of current interest in the HIV-AIDS research community. These questions include the effects of coinfection with the Hepatitis C virus, the involvement of peripheral neuropathy as a factor in frailty, potential neurotoxic effects of antiretroviral medications, and interactive effects with advancing age on sensory and motor functioning.

The purpose of this funding opportunity announcement (FOA) is to support the development of novel tools and technologies through the Small Business Innovation Research (SBIR) program to advance the field of neuroscience research. This FOA specifically supports the development of novel neurotechnologies as well as the translation of technologies developed through the BRAIN initiative or through other funding programs, towards commercialization. Funding can support the iterative refinement of these tools and technologies with the end-user community, with an end-goal of scaling manufacture towards reliable, broad, sustainable dissemination and incorporation into regular neuroscience research.

The Blueprint Neurotherapeutics Network (BPN) encourages applications from small businesses seeking support to advance their small molecule drug discovery and development projects into the clinic. Participants in the BPN are responsible for conducting all studies that involve disease- or target-specific assays, models, and other research tools and receive funding for all activities to be conducted in their own laboratories. In addition, applicants will collaborate with NIH-funded consultants and can augment their project with NIH contract research organizations (CROs) that specialize in medicinal chemistry, pharmacokinetics, toxicology, formulations development, chemical synthesis including under Good Manufacturing Practices (GMP), and Phase I clinical testing. Projects can enter either at the Discovery stage, to optimize promising hit compounds through medicinal chemistry, or at the Development stage, to advance a development candidate through Investigational New Drug (IND)-enabling toxicology studies and phase I clinical testing. Projects that enter at the Discovery stage and meet their milestones may continue on through Development. BPN awardee institutions retain their assignment of IP rights and gain assignment of IP rights from the BPN contractors (and thereby control the patent prosecution and licensing negotiations) for drug candidates developed in this program.