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BJA and SAMHSA are accepting applications for fiscal year (FY) 2015 for grants to enhance court services, coordination, and evidence-based substance abuse treatment and recovery support services of adult drug courts. The purpose of this joint initiative is to allow applicants to submit a comprehensive strategy for enhancing drug court services and substance abuse treatment. Through this solicitation, applicants are competing for two grant awards (a grant from SAMHSA and a separate grant from BJA) for both criminal justice and substance abuse treatment funds with one application. In order to fulfill all of the requirements for this grant program, applicants should comply with the requirements outlined in this announcement as well as those incorporated by reference in the Requirements Resource Guide. These grants are authorized under 42 U.S.C. § 3797u, et seq., and section 509 of the Public Health Service Act, as amended. This announcement addresses Healthy People 2020 Substance Abuse Topic Area HP 2020-SA and SAMHSA's Strategic Initiative on Trauma and Justice. Drug courts funded through this grant may use federal funding and matched funding to serve only nonviolent offenders1 and must operate the adult drug court based on BJA's and the National Association of Drug Court Professionals' publication Defining Drug Courts: The Key Components, which addresses the statutory requirements. This opportunity provides drug court applicants the flexibility to identify the most appropriate evidence-based court (service/docket) model on which to base the drug court, in order to accommodate the needs and available resources of that jurisdiction, so long as the model conforms to the 10 key drug court components (see pages 9-11 of this solicitation), which describe the basic elements that define drug courts. (See page 8 for a definition of "evidence-based.")

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.

NIJ's drugs and crime portfolio supports research on law enforcement efforts to deter, investigate, prosecute, and address illegal drug trafficking, markets, and use. This FY2018 solicitation seeks investigator-initiated proposals to conduct applied research on evidence-based tools, protocols, and policies for State, local and tribal jurisdictions. The two drug priorities are: 1) opioid-related criminal investigation, prosecution, drug intelligence, and community surveillance; and 2) illegal marijuana markets and drug-related violent crime. Opioid research proposals should address narcotics law enforcement, forensic science, and/or medicolegal death investigations; and opioids include heroin, fentanyl, diverted pharmaceuticals, synthetic drugs, and analogues.

The Drug Court Training and Technical Assistance (TTA) Program will fund a TTA provider for family drug courts under Category 1 and a TTA provider for juvenile drug treatment courts under Category 2. The TTA under this program will support OJJDP funded drug courts as well as family drug courts and juvenile drug treatment courts across the nation. In addition, TTA under this program will be coordinated with the Opioid Youth Affected Initiative TTA.

The goal of this FOA is to enhance the diversity of the drug abuse research workforce by providing dissertation awards on topics related to the study of basic and clinical neuroscience, development, epidemiology, prevention, treatment, services, or women and sex/gender differences as they relate to drug abuse. This support will enhance the pool of highly talented drug abuse scientists who conduct research within the funding priority areas (http://www.drugabuse.gov/funding/funding-priorities) or in the NIDA strategic plan (https://www.drugabuse.gov/about-nida/2016-2020-nida-strategic-plan). Applications are encouraged from doctoral candidates in a variety of academic disciplines and programs. This program will ultimately facilitate the entry of promising new investigators into the field of drug abuse research and promote transdisciplinary collaborations. This award is for up to two years of support for the completion of the doctoral dissertation research project.

The goal of this FOA is to enhance the diversity of the drug abuse research workforce by providing dissertation awards on topics related to the study of basic and clinical neuroscience, development, epidemiology, prevention, treatment, services, or women and sex/gender differences as they relate to drug abuse. This support will enhance the pool of highly talented drug abuse scientists who conduct research within the funding priority areas (http://www.drugabuse.gov/funding/funding-priorities) or in the NIDA strategic plan (https://www.drugabuse.gov/about-nida/2016-2020-nida-strategic-plan). Applications are encouraged from doctoral candidates in a variety of academic disciplines and programs. This program will ultimately facilitate the entry of promising new investigators into the field of drug abuse research and promote transdisciplinary collaborations. This award is for up to two years of support for the completion of the doctoral dissertation research project.

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.

The National Institute on Drug Abuse (NIDA) intends to solicit proposals from offerors having the capability to identify and quantify drugs and their metabolites in biological fluids and tissues such as plasma/serum, urine, sweat, saliva, hair and brain and other tissues. These drugs may include cannabinoids, opiates, amphetamines, l alpha acetyl methadol (LAAM), naltrexone, methadone, cocaine, phencyclidine, anabolic steroids, opioid peptides and peptidomimetics, benzodiazepines, and other drugs and their metabolites. The concentrations of such drugs and metabolites usually appear in biological materials at ng/g or ng/ml levels and therefore require the use of state-of-the-art chromatography methods for separation and highly sensitive instrumentations for identification and quantification, such as gas chromatography-mass spectrometry (GC-MS), liquid chromatography-mass spectrometry (LC-MS), and liquid chromatography-tandem mass spectrometry (LC-MS-MS).

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. 

The purpose of this study is to: 1) collect information on practice patterns in special populations to assess possible barriers to generic substitution ; 2) compare clinical practice (e.g., drug product manipulation prior to administration, co-administration with another food or drug) with labeled drug administration information in the assessed populations to identify factors that raise issues for safety and effectiveness with generic substitution; and 3) analyze the impact of product-level, patient-level, and provider-level factors on generic drug substitution. The outcome of this study will help identify research needs, support FDA's regulatory science efforts to monitor and ensure successful generic substitution, and provide evidence to assure the public on generic drug safety and effectiveness.

The FDA Center for Drug Evaluation and Research seeks to support efforts to research, identify key issues, and convene appropriate subject matter experts to help advance regulatory science to promote the increased availability of safe and effective drugs to the public. This effort will inform regulatory science by advancing the scientific discussion of key research topics of interest to both FDA and external stakeholders such as the pharmaceutical industry, healthcare professionals, patients, and academic researchers. FDA seeks support to address research needs identified in the 2018 reauthorization of the Prescription Drug User Fee Act (PDUFA VI) and requirements under the 21st Century Cures Act. The research areas identified in PDUFA and the 21st Century Cures Act represent key scientific priorities identified by FDA, Congress, and stakeholders that, if advanced, will help expedite the development of drugs and improve efforts to assess their safety and effectiveness, thereby increasing the availability of safe and effective drugs to the public.

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 funding opportunity announcement (FOA) is to encourage behavioral intervention development research to test efficacy, conduct clinical trials, examine mechanisms of behavior change, determine dose-response, treatment optimization, and/or ascertain best sequencing of behavioral, combined, sequential, or integrated behavioral and pharmacological (1) drug abuse treatment interventions, including interventions for patients with comorbidities; (2) drug abuse treatment and adherence interventions; (3) drug abuse treatment and adherence interventions that utilize technologies to boost effects and increase implementability and sustainability; (4) interventions to prevent the acquisition or transmission of HIV infection among individuals in drug abuse treatment; (5) interventions to promote adherence to drug abuse treatment, HIV and addiction medications; and (6) interventions to treat substance misuse and chronic pain. Research of interest includes but is not limited to Stage I research.

The purpose of this funding opportunity announcement (FOA) is to encourage behavioral intervention development research to test efficacy, conduct clinical trials, examine mechanisms of behavior change, determine dose-response, treatment optimization, and/or ascertain best sequencing of behavioral, combined, sequential, or integrated behavioral and pharmacological (1) drug abuse treatment interventions, including interventions for patients with comorbidities; (2) drug abuse treatment and adherence interventions; (3) drug abuse treatment and adherence interventions that utilize technologies to boost effects and increase implementability and sustainability; (4) interventions to prevent the acquisition or transmission of HIV infection among individuals in drug abuse treatment; (5) interventions to promote adherence to drug abuse treatment, HIV and addiction medications; and (6) interventions to treat substance misuse and chronic pain. Research of interest includes but is not limited to Stage II and Stage III efficacy research.

The purpose of this FOA is to encourage behavioral intervention development research to test efficacy, conduct clinical trials, examine mechanisms of behavior change, determine dose-response, optimize combinations, and/or ascertain best sequencing of behavioral, combined, sequential, or integrated behavioral and pharmacological (1) drug abuse treatment interventions, including interventions for patients with comorbidities, in diverse settings; (2) drug abuse treatment and adherence interventions for use in primary care; (3) drug abuse treatment and adherence interventions that utilize technologies to boost effects and increase implementability; (4) interventions to prevent the acquisition or transmission of HIV infection among individuals in drug abuse treatment; (5) interventions to promote adherence to drug abuse treatment, HIV and addiction medications; and (6) interventions to treat chronic pain. Research of interest includes but is not limited to Stage II and Stage III efficacy research.

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.

NineSigma, representing Sumitomo Dainippon Pharma Co., Ltd. (https://www.ds-pharma.com/) ("Client"), seeks a drug modality for novel anti-cancer drugs that target immunosuppressive cells and interfere with immune functions, or an evaluation system for creating a drug modality. In recent years, the emergence of immune checkpoint inhibitors has been gradually revealing that the local immunosuppressive environment in tumor affects cancer treatment. This attracts interest in the development of novel antitumor drugs for improving the immune state of the tumor microenvironment. In particular, we look for compounds that target host cells contributing to the formation of the immunosuppressive environment and interfering with these functions.

This Funding Opportunity Announcement (FOA) for R34 applications seeks to support: (a) pilot and/or feasibility testing of innovative new, revised, or adapted prevention intervention approaches to prevent or delay the initiation and onset of drug and alcohol use, the progression to misuse or problem use or alcohol and other substance use disorder, reduce drinking and driving and deaths related to impaired driving, and the drug- or alcohol-related acquisition or transmission of HIV infection and viral hepatitis among diverse populations and settings; and, (b) pre-trial feasibility and acceptability testing for prevention services and systems research. It is expected that research conducted via this R34 mechanism will consist of studies that are a pre-requisite for preparing and submitting subsequent applications for larger scale drug or alcohol abuse prevention and/or drug- or alcohol-related HIV prevention intervention studies. This R34 FOA does not support applications for which the sole focus is development of intervention protocols, manuals, or the standardization of protocols. Any intervention development work must be imbedded within a pilot/feasibility study. Of particular interest is prevention research that addresses current public health priorities and priority settings and systems.

This Funding Opportunity Announcement (FOA) for R34 applications seeks to support: (a) pilot and/or feasibility testing of innovative new, revised, or adapted prevention intervention approaches to prevent or delay the initiation and onset of drug and alcohol use, the progression to misuse or problem use or alcohol and other substance use disorder, reduce drinking and driving and deaths related to impaired driving, prevent suicide attempts (nonfatal and fatal), and the drug- or alcohol-related acquisition or transmission of HIV infection and viral hepatitis among diverse populations and settings; and, (b) pre-trial feasibility and acceptability testing for prevention services and systems research. It is expected that research conducted via this mechanism will consist of studies that are a pre-requisite for preparing and submitting subsequent applications for larger scale drug or alcohol abuse prevention and/or drug- or alcohol-related HIV prevention intervention studies. This FOA does not support applications for which the sole focus is development of intervention protocols, manuals, or the standardization of protocols. Any intervention development work must be imbedded within a pilot/feasibility study. Of particular interest is prevention research that addresses current public health priorities and priority settings and systems.

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.

The PCC has supported world-class research since 2009, spending more than $8.0 M to support novel science. Research and grant-making are the foundation of the PCC and are the focus of everyday business activity. PCC-supported research contributes to a movement in addressing doping's root causes and ultimately decreasing the use of performance-enhancing drugs by all participants in all sports at all levels of play. With an emphasis on original work that focuses on improving existing analytical methods for detecting particular drugs, developing new analytical methods to test for substances not currently detectable, and discovering cost-effective approaches for testing widely abused substances across all levels of sport, the following areas of investigation reflect the PCC's current research priorities: - Developing methods of cost-effective testing to detect and deter the use of banned and illegal substances. - Developing testing protocols to detect designer substances used for doping purposes. - Improving existing analytical methods to detect particular drugs, ex. GH, IGF-1, EPO, hCG. - Developing analytical methods to detect performance enhancing drugs not currently detectable. - Longitudinal urinary excretion patterns, metabolism and dose-concentration. - Critical reviews to support interpretation of laboratory data. - Alternative specimens, (ex. oral fluid, dried blood/plasma spots) for testing.