NIH Challenge Grants in Health and Science Research
National Institute on Drug Abuse
NIH has received new funds for Fiscal Years 2009 and 2010 as part of the American Recovery & Reinvestment Act of 2009 (Recovery Act), Pub. L. No. 111-5. The NIH has designated at least $200 million in FYs 2009 - 2010 for a new initiative called the NIH Challenge Grants in Health and Science Research.
This new program will support research on topic areas that address specific scientific and health research challenges in biomedical and behavioral research that would benefit from significant 2-year jumpstart funds.
The NIH has identified a range of Challenge Areas that focus on specific knowledge gaps, scientific opportunities, new technologies, data generation, or research methods that would benefit from an influx of funds to quickly advance the area in significant ways. Each NIH Institute, Center, and Office has selected specific Challenge Topics within the broad Challenge Areas (pdf, 1.7 MB) related to its mission. The research in these Challenge Areas should have a high impact in biomedical or behavioral science and/or public health.
NIH anticipates funding 200 or more grants, each of up to $1 million in total costs, pending the number and quality of applications and availability of funds. In addition, Recovery Act funds allocated to NIH specifically for comparative effectiveness research (CER) may be available to support additional grants. Projects receiving these funds will need to meet this definition of CER: "a rigorous evaluation of the impact of different options that are available for treating a given medical condition for a particular set of patients. Such a study may compare similar treatments, such as competing drugs, or it may analyze very different approaches, such as surgery and drug therapy." Such research may include the development and use of clinical registries, clinical data networks, and other forms of electronic health data that can be used to generate or obtain outcomes data as they apply to CER.
The application due date is April 27, 2009.
Broad Challenge Areas and Specific Challenge Topics
Each NIH funding component (Institute/Center) has identified specific challenges within the broad Challenge Areas related to its mission. Those marked with an asterisk (*) are high priority areas
For the National Institute on Drug Abuse, these Challenge Topics are:
(01) Behavior, Behavioral Change, and Prevention
01-DA-101 New Tools for Social Neuroscience and Neurofeedback. NIDA is soliciting research to validate existing measures and techniques, and to encourage the development, improvement and/or adaptation of technologies which, by the end of the funding period, will be verified field-deployable tools that can detect and deliver feedback with maximum precision and reliability. Building on currently available technologies, these tools will be effective and practical instruments for the early identification of children and adolescents with insufficient self-regulation and for incorporation into therapeutic programs facilitating the amelioration of these individuals' dysregulation. Contact: Dr. Elizabeth M. Ginexi, 301-402-1755, LGinexi@nida.nih.gov and Steven Grant, Ph.D. 301-443-4877 email@example.com
01-DA-102 Individual-based model of social behavior. Employ animal behavioral models to understand social behaviors as antecedents to, or vulnerability for, drug abuse and addiction; effects of drugs of abuse on social interactions; and the consequences of addiction on social behaviors. Includes studies of neurobiological substrates and environmental influences on the complex interplay between social behaviors and drug abuse behavior. Also includes changes in social repertoire that emerge during the developmental course of addiction. Contact: Dr. Minda Lynch, 301-435-1322, firstname.lastname@example.org and Bethany Deeds, Ph.D., 301-402-1935, email@example.com
01-DA-103 Identifying phenotypic markers for positive behavioral change. Identify intermediate phenotypes that predict sensitivity to interventions designed to block the development of drug abuse, block or reduce compulsive drug- taking, or promote abstinence. Phenotypes can be identified using physiological, behavioral, cognitive or neurobiological assessments in animal models or human studies. Research with animal models should manipulate environmental, behavioral or neurobiological variables that alter the sensitivity to these interventions. Contact: Dr. Minda Lynch, 301-435-1322, firstname.lastname@example.org and Elizabeth Ginexi, Ph.D., 301-402-1755, LGinexi@nida.nih.gov and James Bjork, Ph.D.. 301-443-4209 email@example.com
01-DA-104 Functional Roles of Glia-Derived Factors in Mediating Drug Abuse Behavior. Emerging data suggest that the physiological functions of neuroimmune factors such as cytokines and chemokines, and of other factors derived from glia residing within the nervous system actively participate in modulating neuronal function and processes that contribute to and underlie behavioral change. This offers a new framework towards understanding the roles of glia-derived factors in the development and progression of drug abuse and addiction. Contact: Dr. Roger G Sorensen,301-443-3205, firstname.lastname@example.org and Woody Lin, Ph.D. 301 435-1318 email@example.com
01-DA-105 Capturing social network information for groups at high risk for negative health behaviors. Research in this area is needed to enhance existing methodologies and/or devise novel methods that will capture social network information among groups at heightened risk for particular negative health behaviors such as smoking, and use or abuse of illicit drugs and prescription medications. Furthermore, research on characterizing social networks (e.g., sexual networks, drug use networks) to identify protective and risk factors that affect HIV transmission among drug using populations is needed. Novel methods and strategies for doing so are encouraged. Contacts: Dr. Harold I Perl, 301-443-9982, firstname.lastname@example.org and Dr. Jacques Normand, 301-443-1470, email@example.com and Dr. Jessica Chambers, 301-443-2237, firstname.lastname@example.org and Peter Hartsock, Dr.P.H., 301-402-1964, email@example.com
01-DA-106 Development of behavioral and social interventions that reduce stigma and improve quality and accessibility of health care services in low resource settings. Residents of economically deprived neighborhoods in this country have limited access to health care. Accessing HIV/AIDS health care services, including HIV testing is further exacerbated by the stigma associated with drug abuse and HIV infection in those settings. This initiative is soliciting applications that would translate existing knowledge related to the causes and consequences of stigma into pilot interventions that can prevent or mitigate stigma and its associated negative effects on HIV/AIDS health care services among drug users. Contact: Dr. Jacques Normand, 301-443-1470, firstname.lastname@example.org and Aria Crump, Sc.D., 301-435-0881, email@example.com, Ivan Montoya, M.D., M.P.H., 301-443-8639, firstname.lastname@example.org. Cecelia Spitznas, Ph.D., email@example.com, 301-402-1488.
01-DA-107 Identifying phenotypic markers for positive behavior change. Identify reliable, robust intermediate phenotypic markers (using cognitive neuroscience and behavioral economics) that can be used to personalize approaches to support positive health behavior change related to substance abuse and HIV risky decision making behavior. Examples include behavioral disinhibition, delay discounting and other measures of impulsivity, risk perception, sensitivity to reward and punishment, and implicit cognition. Contact: Dr. Lynda Erinoff, 301-443-1470, firstname.lastname@example.org and Elizabeth Ginexi, Ph.D., 301-402-1755, LGinexi@nida.nih.gov and Woody Lin, Ph.D. 301 435-1318 email@example.com
01-DA-108 Test default options to promote healthier behaviors. Exploration by behavioral economists and clinicians to develop and test default options (e.g., placement of fresh fruit displays in stores, the location of parking spaces at the workplace) to promote healthier behaviors. Studies may include incentives and policies for healthier behavior by program staff and providers (e.g. stop smoking programs for drug abuse treatment staff). Contact: Debbie Grossman, M.S., 301-443-2249 Dg9a@nih.gov and Jacqueline Lloyd, Ph.D., M.S.W., 301-443-8892, firstname.lastname@example.org and James Bjork, Ph.D.. 301-443-4209 email@example.com
01-DA-109 Behavioral and/or pharmacotherapeutic intervention research in the area of neonatal exposure to substances of abuse. Develop and test behavioral and or pharmacotherapeutic interventions for the neonate to regulate behavior in problem areas, such as feeding problems, irritability, and vomiting problems that ensue due to substance exposure in utero. The behaviors of the neonate exposed to substances are going to constantly change with a developing nervous system and in a milieu in which the mother may have non-appropriate caregiver response. Contact: Steve Oversby, 301-435-0762 firstname.lastname@example.org and Nicolette Borek, Ph.D. 301-402-0866 email@example.com
01-DA-110 Identify and/or evaluate dietary supplements that could be used in treating substance abuse disorders. There is abundant preclinical and clinical evidence that suggest dietary therapies and behavioral interventions can promote neurogenesis, diminish susceptibility to metabolic and excitotoxic injury (e.g., diets rich in antioxidants), and/or counteract stress responses within the brain. Dietary regimens or supplements can be evaluated as individual treatments or as adjuncts to FDA-approved medications. Contact: Kris Bough, 301-443-9800, firstname.lastname@example.org and Allison Hoffman, Ph.D., 301-402-5088, email@example.com and Woody Lin, Ph.D. 301 435-1318 firstname.lastname@example.org
01-DA-111 Approaches to study the interactions among individual behaviors, social and physical environments, and genetic/epigenetic processes during critical developmental periods. NIDA is soliciting research that integrates environmental and developmental variables with genotypic information in order to permit comprehensive model-building and hypothesis testing for determining genetic, environmental, and developmental contributions to substance abuse and related phenotypes. Contact: Dr. Karen Y. Sirocco, 301-451-8661, email@example.com and Joni Rutter, Ph.D., 301-435-0298, firstname.lastname@example.org and Naimah Weinberg, M.D., 301-443-6504, email@example.com
02-DA-101 Research on Obtaining Consent for Illicit Drug Users. NIDA is soliciting research to evaluate the consent form and the procedure to obtain consent from individuals seeking to participate in drug abuse clinical trials. Research to determine their impact on the ability to recruit potential study subjects into drug abuse trials would be needed to determine what measures may be necessary to ensure research subjects are protected. Contact: Bob Walsh, (301) 443-9825, firstname.lastname@example.org and Carmen L. Rosa, M.S., 301-443-9830, email@example.com and Richard Jenkins, Ph.D., 301-443-1923, firstname.lastname@example.org
02-DA-102 Confidentiality in Electronically Shared Information of Illicit Drug Use Behaviors. NIDA is soliciting research assessing current areas of risk with web-based electronic capture of research data in drug abuse treatment clinical trials as well as suggestions for improvements to existing paradigms to ensure secure transmission of data. Identification of potential future areas of risk regarding the use of data standards and changing regulatory requirements should also be explored. Contact: Bob Walsh, (301) 443-9825, email@example.com and Carmen L. Rosa, M.S., 301-443-9830, firstname.lastname@example.org
02-DA-103 Translation of genetic knowledge to clinical practice. Address ethical issues related to access to broad sharing and use of new genetic information and technologies for addiction research to improve treatment and prevention options for addicts. Important issues include the identifiability of genetic/genomic information, return of research results and incidental findings to high risk subjects, and alternative models of informed consent for broad data sharing for research. Contact: Dr. Joni Rutter, 301-435-0298 email@example.com and Hal Gordon, Ph.D., 301-443-4877, firstname.lastname@example.org, Shoshana Y. Kahana, Ph.D., 301-443-2261, email@example.com. Elizabeth M. Ginexi, Ph.D., 301-402-1755, LGinexi@nida.nih.gov.
02-HG-101* Informed consent and data access policies. The creation of large databases that include genomic information on individual participants, coupled with the move to universal electronic medical records, makes it increasingly possible to identify individual research participants in databases, despite efforts to "de-identify" their data, and potentially to unearth an individual's private medical information. Research is urgently needed to address the implications of this for recruitment, informed consent, and data access policies in biomedical research. NIDA Contact: Dr. Marsha Lopez, 301-402-1846, firstname.lastname@example.org, Cecelia Spitznas, Ph.D., 301-402-1488, email@example.com. Carol A. Cushing, B.B.A., R.N., 301-443-9815, firstname.lastname@example.org. Jonathan D. Pollock, Ph.D., 301-435-1309, email@example.com.
02-OD(OSP)-101* Unique Ethical Issues Posed by Emerging Technologies. Advances in biotechnology and biomedical science raise novel ethical, legal, and social issues. Research in this area is needed to understand the unique ethical concerns related to emerging technologies (e.g. biotechnology, tissue engineering, nanomedicine, and synthetic biology). These include issues such as dual use research, privacy, safety, intellectual property, commercialization and conflict of interest, among others. Research is also needed to assess how these novel issues are addressed under current oversight and regulatory structures and identify where there may be gaps and/or need for revised or new oversight approaches. NIDA Contact: Dr.Kathy Etz, 301-402-1749, firstname.lastname@example.org, Jessica Chambers, Ph.D., 301-443-2237, email@example.com. Thomas Aigner, Ph.D., 301-435-1314, firstname.lastname@example.org.
02-RR-101* Recontact Issues in Genotype and Genome-Wide Association Studies. Genotype and genome-wide association studies create challenging re-contact issues if subjects are later to be asked to return for clinical research including phenotyping. Applicants would propose 2-year awards for pilot programs that would be implemented at 3 or more affiliated sites to develop and apply IRB guidelines that addressed ethical barriers (e.g., re-contacting) in genotype - phenotype studies. This idea is submitted through NCRR on account of the ethics work underway at the Clinical and Translational Science Awards (CTSAs) and, if accepted, would be developed with NHGRI's ELSI Division. NIDA Contact: Dr. Louise Wideroff, 301-443-8663, email@example.com, Hal Gordon, Ph.D., 301-443-4877, firstname.lastname@example.org. Jonathan D. Pollock, Ph.D, 301-435-1309, email@example.com.
(03) Biomarker Discovery and Validation
03-DA-101* Biomarkers for Pain. Pain research has been greatly hampered by the unreliable nature of self-report based instruments. The establishment of objective, affordable and reliable pain biomarkers and measurements would advance our understanding of pain mechanisms, provide a basis for improved clinical management of pain, help assess an individual's risk for becoming addicted to opiate analgesics, and establish much needed objective measures of treatment success or failure. Contact: Dr. Yu Lin, 301-435-1318, firstname.lastname@example.org and Richard Denisco, M.D., M.P.H., 301-594-4371, email@example.com and David Thomas, Ph.D., 301-435-1313, firstname.lastname@example.org
03-DA-102* Novel Molecular Targets From Unexpected Sources. The quiescent databases left behind by unsuccessful medication trials represent an incredibly rich resource with the potential to turn failure into success. Through the use of strategic alliances (e.g., with FDA Critical Path Initiative) and novel approaches, such as target deconvolution and network pharmacology, these databases, can be transformed into engines of discovery to dramatically increase our ability to recognize novel molecular targets that underlie robust biological responses such as liability to drug abuse. Contact: Dr. Elena Koustova, 301-496-8768, email@example.com and Nora Chiang, Ph.D., 301-443-5280 or 301-443-8099, firstname.lastname@example.org
03-DA-103* Comprehensive biomolecular mass spectrometry. Current detection methodologies provide a narrow window into just 1% of the molecular universe. As a consequence, there is a strong need to develop new mass spectrometric technologies for the faster, more sensitive, more specific, and more comprehensive identification of biomolecules (both charged and neutral proteins and lipids) in tissue samples and single cells. This initiative seeks to leverage the potential of cutting edge technologies in the areas of ion mobility and vacuum ultraviolet photofragmentation for developing molecular identification and quantitation instruments that could be deployed in the clinical as well as research environments. Contact: Dr. Christine Colvis, 301-443-6480, email@example.com
03-DA-104* Biosignatures of Drug Exposure. Chronic exposure to a pathogenic agent is one of the defining features of conditions such as infectious diseases and substance use disorders. This characteristic presents a unique opportunity to develop and harness the power of biosignatures that could reliably predict disease vulnerability, trajectory, and treatment outcome. This initiative is specifically designed to uncover and validate peripheral endogenous biomarkers in animal models exposed to chronic drug exposure, withdrawal, or relapse that may serve as surrogates for CNS changes in humans. The results are also likely to spur significant advances in a host of related disorders. Contacts: Dr. Ivan D. Montoya, 301-443-8639, Imontoya@mail.nih.gov and Jeffrey Schulden,M.D., 301-402-1526, and firstname.lastname@example.org, and Elena Koustova, 301-496-8768, email@example.com
03-DA-105 Biomarkers, stress and immune function. Stress is known risk factor for substance abuse and relapse, and stress, substance abuse and withdrawal are known to impact immune function. There is a need to identify biomarkers to assess the impact of stress, both social and biological (including substance abuse and withdrawal), on immune function. Studies addressing specific immune or inflammatory responses to HIV/SIV infection are of particular interest. Dr. Diane Lawrence, 301-443-1470, firstname.lastname@example.org and Richard Jenkins, Ph.D., 301-443-1923, email@example.com and Hal Gordon, Ph.D., 301-443-4877, firstname.lastname@example.org, and Albert Avila, Ph.D., 301-496-8804, email@example.com and Ivan D. Montoya, 301-443-8639, Imontoya@mail.nih.gov, Ivan Montoya, M.D., M.P.H., 301-443-8639, firstname.lastname@example.org. Hal Gordon, Ph.D., 301-443-4877, email@example.com. Albert Avila, Ph.D., 301-496-8804, firstname.lastname@example.org
03-DA-106 Biomarkers in mental disorders. There is a need for innovative approaches to identify biomarkers that can predict illness onset, define diagnosis, identify potential individualized therapeutic targets, and/or assess treatment responses related to HIV-associated neurological and neurocognitive impairment. Studies incorporating substance abusers or model systems that include exposure to abused substances would be appropriate. Dr. Diane Lawrence, 301-443-1470, email@example.com and Marsha Lopez, Ph.D., 301-402-1846, firstname.lastname@example.org and Woody Lin, Ph.D. 301 435-1318 email@example.com, Ivan Montoya, M.D., M.P.H., 301-443-8639, firstname.lastname@example.org. Shoshana Y. Kahana, Ph.D., 301-443-2261, email@example.com.
03-DA-107 Biomarkers of substance abuse comorbidity. This initiative will support the development of molecular/proteomic biomarkers that will help in the detection, assessment and treatment of drug abuse comorbidity consisting of infections; and provide objective testing methods, help in the understanding of molecular bases of diseases, disease processes and progression. Contact: Jag H. Khalsa, (301) 443-2159 firstname.lastname@example.org and Richard Jenkins, Ph.D., 301-443-1923, email@example.com and Woody Lin, Ph.D. 301 435-1318 firstname.lastname@example.org
(04) Clinical Research
04-DA-101 Evaluation of novel, rationalized poly-pharmacotherapeutic treatment strategies for substance abuse. Phenotypic robustness is underpinned by redundant and compensatory functional signaling routes. Network biological analysis predicts that modification of a single target by a drug is not nearly as likely to affect disease outcome as would rational combinations of drugs that target multiple, complementary mechanisms. Applications will focus on combination of medication strategies for the treatment of substance use disorders. Contact: Kris Bough, 301-443-9800, email@example.com
04-DA-102 A New Look at Longitudinal Data. NIH has funded numerous prospective longitudinal epidemiologic, developmental, prevention, and treatment studies that have resulted in extensive data sets. A real need exists for additional funding to analyze these rich data resources; much of these data remain unmined due to budget and time constraints. The Challenge Grants could provide support for new research questions from already collected data. The grants could also support research to add outcome measures that were not originally included in the longitudinal project, for example, adding substance use and other behavioral outcomes to a study of smoking and asthma. Contact: Dr. Nicolette Borek, 301-402-0866, firstname.lastname@example.org and Marsha Lopez, Ph.D., 301-402-1846, email@example.com
04-DA-103 Extending the Reach of Web-Based Drug Abuse Prevention and Treatment to Rural and Other Remote Locations. Many persons living in remote or rural locations have limited opportunities to obtain drug abuse treatment services, due to a lack of available service settings, the barrier of traveling long distances, and/or the perceived lack of private and confidential treatment options. This program seeks to develop web-based drug abuse treatment interventions that do not necessitate frequent in-person visits to a central facility. The interventions could take various forms, including: accessing interactive web-sites, video linkages with an individual counselor, video linkages with counselor-led group sessions, and asynchronous linkages with moderated chat rooms. Contacts: Dr. Harold Perl, 301-443-9982, firstname.lastname@example.org and Dr. Jacqueline Lloyd, 301.443.8892, Lloydj2@nida.nih.gov and Dr. Cecelia Spitznas, 301-402-1488, email@example.com
04-DA-104 Primary Screening for Psychiatric Problems. A standardized screening assessment for behavioral and psychiatric problems would greatly increase the identification of patients' problems in medical settings and would also promote adoption of a standardized core research assessment, facilitating substance abuse, comorbidity and other psychiatric disorder identification across multiple clinical and research settings and maximize data utilization and cross situational analyses. It would also facilitate research use of diagnostic and treatment data from the intervention field and the translation of empirical data into applied contexts. The goal is to develop a relatively brief, easily administered and scored assessment with strong abuse and addiction validity. Contact: Dr. Jeffrey Schulden, 301-402-1526, firstname.lastname@example.org
04-DA-105 HIV - Viral Hepatitis Co-Morbidity. The aims of this research topic area are to investigate the feasibility, acceptability, efficacy, and effectiveness of combined screening for HIV, Hepatitis-B and Hepatitis-C at general and specialty medical clinics, emergency departments, trauma centers, intensive care units, community treatment centers for alcohol and substance abuse, sexual transmitted disorders clinics, detention centers, educational centers, etc. Furthermore, research is needed to examine the effectiveness of linking screening for HIV and viral hepatitis to appropriate medical care for those infected. Contact: Dr. Raul N. Mandler, 301-435-0645, email@example.com and Jag H. Khalsa, Ph.D., (301) 443-2159 firstname.lastname@example.org and Richard Jenkins, Ph.D., 301-443-1923, email@example.com
04-DA-106 Integrating cost-effectiveness analysis into clinical research. This initiative calls for cost-effectiveness analysis of new and innovative HIV/AIDS interventions (i.e., prevention and treatment) as well as of existing interventions with demonstrated effectiveness. Such cost-effectiveness research should provide information that can inform and guide future policies that support the allocation of health resources for the prevention and/or treatment of HIV/AIDS. Contact: Dr. Jacques Normand, 301-443-1470, firstname.lastname@example.org and Sarah Duffy, Ph.D., 301-451-4998, email@example.com, Ivan Montoya, M.D., M.P.H., 301-443-8639, firstname.lastname@example.org
04-DA-107 Improving quality of life of patients and family following a war-related traumatic injury. Develop and test personalized behavioral or pharmacological interventions to prevent development of or treat psychiatric disorders, addictions, or other complications in persons with war-related traumatic injuries both in theatre and during the post hospitalization transition period, with the ultimate goal of improving the health and quality of life of affected individuals and families. Preventive and treatment interventions for families would be applicable during pre-deployment, deployment, and post-deployment stages. Contact: Dr. Steve Sparenborg, 301-496-4844, Sparenborgs@nida.nih.gov and Eve Reider, 301-402-1720, email@example.com and Dr. Cecelia Spitznas, 301-402-1488 firstname.lastname@example.org, Ivan Montoya, M.D., M.P.H., 301-443-8639, email@example.com
04-DA-108 Development of effective approaches to increase minority recruitment and retention into clinical trials. Minority participation in substance abuse and HIV/AIDS clinical trials has been very low and new tools are needed to improve this in order to advance knowledge in treatments that are most effective in helping minority groups. This initiative encourages researchers to develop and evaluate innovative approaches to promote subject retention and initiatives that build partnerships and utilize new and non-traditional approaches to recruitment and retention. Contacts: Dr. Lynda Erinoff, 301-443-1470, firstname.lastname@example.org and Carmen L. Rosa, M.S., 301-443-9830, email@example.com
04-DA-109 Medication development for hepatic fibrosis. HIV/HCV co-infection among drug abusers is a major cause of hepatic fibrosis, and HCV-related liver disease is the leading cause of death among those on HAART therapy. Given the morbidity/mortality associated with this disease, there is an urgent need for translation of emerging antifibrotic molecules into effective therapies. Expediting clinical trials for compounds that have successfully undergone preclinical studies has the potential to make much needed medications available and reduce the need for liver transplantation. Contact: Dr. Lynda Erinoff, 301-443-1470, firstname.lastname@example.org and Jag H. Khalsa, Ph.D., (301) 443-2159 email@example.com and Richard Jenkins, Ph.D., 301-443-1923, firstname.lastname@example.org
04-DA-110 Screening, Brief Intervention, and Referral to Treatment (SBIRT). Excessive use, abuse, and/or dependence on drugs and alcohol have a tremendous impact on individual health status, contributing to a variety of medical conditions having high levels of associated mortality and morbidity. The attention required to attend to these conditions also places increased burden on the medical system, including considerable costs that are often not recovered. Under the NIH Challenge Initiative, the aim of this research topic area is to investigate the feasibility, efficacy, effectiveness, sustainability and cost benefits of using screening, brief intervention and referral to treatment (SBIRT) strategies to decrease the medical and social burden of alcohol and/or drug abuse in the US. Contact: Dr. Raul N. Mandler, 301-435-0645, email@example.com and Dr. Cecelia Spitznas, 301-402-1488, firstname.lastname@example.org and Richard Denisco, M.D., M.P.H., 301-594-4371, email@example.com
04-DA-111 Clinical Neurobiology of Chronic Opioid Use and Misuse. There is an urgent need for research that will more thoroughly delineate the neurobiological implications of long-term opioid use. This knowledge gap is of particular concern when it comes to the developing brain - and the urgency is underscored by the fact that increasing numbers of adolescents and young adults are using opioid medications, prescribed and otherwise. Research funded in this area could be instrumental in the development of evidence-based clinical guidelines for prescribing and managing long-term opioid pharmacotherapy for chronic pain and opioid dependence, and in furthering our understanding of the treatment needs of opioid dependent patients. Contact: Dr. David Liu, 301-443-9802, firstname.lastname@example.org and Petra Jacobs, M.D., 301-451-6338, email@example.com and Woody Lin, Ph.D. 301 435-1318 firstname.lastname@example.org
04-DA-112 Enhancing the Impact of Behavioral Interventions using New and Innovative Technology. The ultimate goal of the NIH is to improve public health as measured in terms of biological well-being, which is multidimensional and is strongly shaped by behavioral variables. Neuroscience research on brain plasticity has demonstrated, unequivocally, that the brain changes as a result of behavior changes. Technological advancements have made it possible to better measure the impact of behavioral interventions on specific biological targets and processes. Innovative 2-year projects that will utilize technology to enhance efficacious behavioral interventions by targeting specific neurobehavioral and/or biological processes (e.g., risk taking, impulsivity, decision making) involved in drug abuse/addiction. Contact: Dr. Lisa Onken, 301-443-2235, Lisa_Onken@nih.gov and Elizabeth Ginexi, Ph.D., 301-402-1755, LGinexi@nida.nih.gov
04-DA-113 Development of behavioral and social interventions that reduce stigma and improve quality and accessibility of health care services in low resource settings. In the same manner that the effects of stigma magnify the personal and societal problems related to substance use disorders and HIV infection, addressing, preventing, or mitigating stigma of these disorders and their effects on recovery can profoundly improve the lives of individuals with these disorders, their families, and the larger society. The engagement of key stakeholders (such as professional treatment programs, healthcare-delivery disciplines, and informal care-giving networks) in offering viable treatments that reduce the stigma of substance use disorders and HIV infection may be critical to implementation of treatments that enhance and sustain positive health. Thus, there is a critical need in substance abuse and HIV treatment to translate existing knowledge related to the causes and consequences of stigma into scalable pilot interventions that can measure stigma and prevent or mitigate its negative effects on recovery from these disorders. Contact: Dr. Udi E. Ghitza, 301-443-9983, email@example.com and Dionne Jones, Ph.D., 301-402-1984, Djones1@nida.nih.gov
04-DA-114 New and innovative technologies to monitor patient behaviors and clinical status in clinical trials. Develop and test new affordable, technologies to enable remote, centralized monitoring of physiologic, behavioral and neurologic indices across various health and mental disorders as well as study medication compliance and overall treatment compliance, and adverse effects in clinical trials. These technologies should provide opportunities to enhance efficiency in clinical trials, as well as to collect more "real life" data. Identity verification and time stamp information will be needed in some cases. Contacts : Dr. Cecelia Spitznas, 301-402-1488, firstname.lastname@example.org and Tom Hilton, Ph.D., 301-443-6504, email@example.com and Richard Jenkins, Ph.D., 301-443-1923, firstname.lastname@example.org
04-DA-115 The effect of drug addiction treatment immunotherapies (monoclonal antibodies or vaccines) on the fetus. Preclinical assessment of changes in maternal and fetal (organ) drug distribution following maternal administration of an immunotherapy. Preclinical studies to assess teratology and pharmacokinetics of immunotherapies, alone and in combination with drugs of abuse or nicotine. Contact: Jamie Biswas, 301-443-8096, email@example.com
04-DA-116 Research to develop novel pharmacotherapy strategies for the treatment of pregnant/postpartum women with substance related disorders. Substance abuse during pregnancy often occurs in the context of complex environmental factors and poly-drug exposure, as well as medical conditions which are associated with adverse neonatal consequences. Much is known in regard to the negative effects of substances of abuse on the pregnant/post partum women and their substance exposed neonates but relatively little is known in regard to medication treatment strategies and research methodology. Contact: Steve Oversby, 301-435-0762, firstname.lastname@example.org
04-DA-117 Drug response and toxicity. Application of pharmacogenetics and pharmacogenomics to addiction research by the development or use of pre-clinical models, new technologies and approaches to complement pharmacogenomic studies to enhance signal to noise ratios and aid mechanistic studies, and consensus standards for normal and altered phenotypes in response to drugs of abuse, or treatments for drug addiction. Contact: Dr. Joni Rutter, 301-435-0298, email@example.com and Ivan Montoya, M.D., M.P.H., 301-443-8639, Imontoya@mail.nih.gov
04-DA-118 Role of the human gut microbiome in chronic diseases. Applications will be invited to understand the interactive effects of drugs of abuse and gut microbiome on the pathogenesis of chronic diseases such as HIV and HCV. Contact: Dr. Vishnu Purohit, 301-594-5754, firstname.lastname@example.org and Jag H. Khalsa, Ph.D., (301) 443-2159 email@example.com
04-DA-119 Novel methods in mucosal immunology. Gut-associated lymphoid tissue (GALT) is the largest mucosal lymphoid organ and the major site of HIV replication which is associated with severe CD4+ T cell depletion. Various drugs of abuse have also been shown to compromise immune system as well as disrupt intestinal integrity. Understanding the interactive effects of drugs of abuse and HIV infection on GALT may help prevent progression of HIV-associated pathological conditions. Contact: Dr. Vishnu Purohit, 301-594-5754, firstname.lastname@example.org
04-DA-120 Medication development for hepatic fibrosis. Liver fibrosis is a common feature of chronic liver diseases such as Hepatitis C, alcoholic liver diseases and nonalcoholic steatohepatitis, and it can progress to cirrhosis without intervention. There is an urgent need for translation of potential antifibrotic molecules into effective therapies. Activation of cannabinoid 2 (CB2) receptors and inactivation of cannabinoid 1 (CB1) receptors have been shown to attenuate liver fibrosis in animal model of fibrosis. Preclinical studies are required to test the efficacy of various CB1 antagonists and CB2 agonists in the treatment of liver fibrosis. Contact: Dr. Vishnu Purohit, 301-594-5754, email@example.com and Jag H. Khalsa, Ph.D., (301) 443-2159 firstname.lastname@example.org
(05) Comparative Effectiveness Research
05-DA-101* Behavioral and Medication Interventions To Treat Drug Abuse Disorders in Non-Specialty Care Settings. Treatment for substance use disorders has most commonly been provided in specialty care settings such as residential therapeutic communities, methadone maintenance treatment clinics, and dedicated inpatient or outpatient substance abuse treatment programs. One way to broaden access to substance abuse treatment would be to expand care in non-specialty care settings (i.e., primary care settings such as emergency departments, general medicine and public health clinics), and the criminal justice system. Research is needed on the comparative effectiveness of treatment interventions delivered in non-specialty care settings compared to those in traditional settings. Contact: Dr. Redonna Chandler, 301-443-8768, email@example.com and Dr. Will Aklin, 301-4433207, firstname.lastname@example.org and Petra Jacobs, M.D., 301-451-6338, email@example.com
05-DA-102* Treatment of Substance Abuse and Related Health Consequences Using Web-Based Technologies. Evidence-based behavioral therapies are not routinely integrated in substance abuse treatment programs because of financial constraints or inadequate provider training. Technology is increasingly being harnessed as a low-cost option for teaching behavioral skills to substance users, thereby broadening their availability. Research is needed to compare the effectiveness of already developed web-based technologies (e.g., cognitive behavioral therapy; community reinforcement; HIV risk reduction) with traditional modes of treatment delivery (e.g., counselors, physicians, etc.) in order to optimize use of the web for expanding delivery of science-based behavioral treatment, with fidelity, and in a manner that reduces cost and staff burden. Contact: Dr. Cecilia Spitznas, 301-4021488, firstname.lastname@example.org and Tom Hilton, Ph.D., 301-443-6504, email@example.com
05-DA-103* Integrated vs. Separate Treatment of Substance Abuse and Comorbid Conditions. Comorbid psychiatric disorders as well as other serious medical conditions such as infectious diseases (e.g., HIV/AIDS) and chronic pain commonly co-occur with substance use disorders. Additionally, people addicted to one substance are frequently addicted to others. Comparative effectiveness research could fill a knowledge gap regarding the benefits of treating conditions in an integrated manner versus separately, pointing treatment providers and physicians toward the most effective intervention strategies for multiple disorders, identifying optimal methods of coordinating and delivering treatment while ensuring its quality and access, reducing costs, preventing further illness and disability, and improving community functioning and integration. Contact: Bennett Fletcher, Ph.D., 301-443-6504, firstname.lastname@example.org and Shoshana Kohana, Ph.D. 301-443-2261, email@example.com and David Liu, M.D., 301443-9802, firstname.lastname@example.org
05-DA-104* Comparing Drug Treatment Effectiveness in Ethnic Minority Populations. Research suggests that treatment response can vary among different minority populations due to genetic, environmental and cultural factors. Still, it is unknown which treatments work best for which ethnicities. Comparative effectiveness studies in ethnic minorities would test pharmacotherapies and behavioral treatments for substance abuse that have already shown efficacy in some populations. Results could reveal optimal treatment types for various populations, many of which are currently under-studied or under-served in terms of treatment need, including African Americans, Native Americans, and Hispanics. Contacts: Dr. Mary Ellen Michel, 301-443-6697, email@example.com and Dr. Lula Beatty, 301-443-0441, Lb75x@nih.gov and Tom Brady, Ph.D., 304-443-6504, Bradyt22@mail.nih.gov
05-DA-105* Comparing Episodic and Continuous Care for Drug Abuse Treatment. Concerns have been raised over the mismatch between usual drug abuse treatment, which follows an acute care model, and emergent perspectives that addiction is a chronic illness. To treat drug abuse and addiction as a chronic illness implies that treatment providers should follow acute care with long-term monitoring and interventions to prevent a recurrence of drug use and to re-engage relapsed patients in treatment in order to minimize the consequences of the relapse. Research is needed on the comparative effectiveness of usual drug abuse treatment with drug treatment based on a model of continuing chronic illness care. Contacts: Shoshana Kohana, Ph.D., 301-443-2261, firstname.lastname@example.org and Bennett Fletcher, Ph.D., 301.443.2274, email@example.com and Petra Jacobs, M.D., 301-451-6338, firstname.lastname@example.org
(06) Enabling Technologies
06-AT-101* Imaging correlates of brain states. Exploration of brain imaging technologies to provide insight into higher-order states such as awareness of self, focused attention, stress, meditative states, calm and other emotional states; utilize brain imaging to develop objective measures and rigorous, quantitative evaluation of subjective states. NIDA Contact: Dr. Steven Grant, 301-443-4877, email@example.com
06-DA-101 Epigenome-Wide Association Studies (EWAS). Given current technology, it would be prohibitively expensive to perform epigenome-wide association study in which epigenome-wide analysis is performed on thousands of cases and controls. This barrier significantly impedes our ability to identify epigenotypes important in common human diseases. The development of an approach enabling low cost EWAS scans would transform epigenomic investigations into diseases such as addiction. Contact: Dr. John Satterlee, 301-435-1020, firstname.lastname@example.org
06-DA-102 Tool Development for the Neurosciences. Tools that unambiguously identify, manipulate, and report from neurons in vivo and in vitro are needed to help us understand interactions within neural circuits, to examine the functions of types of neurons that are derived from different brain regions, and to determine how selective and conditional silencing or activation of individual neurons or groups of similar neurons may alter functional outcomes, including behavior. This methodology can contribute greatly to the identification of real-time responses to drugs of abuse or to therapeutic interventions, and can play a key role in helping us understand endogenous neuroprotective mechanisms and the repair of frank brain damage or neural dysfunction as a result of drug abuse. Contact: Dr. Nancy Pilotte, 301-435-1317, email@example.com and Steven Grant, Ph.D. 301-443-4877 firstname.lastname@example.org
06-DA-103 Identification of chemical modulators of epigenetic regulators. There are a limited number of pharmacological agents available to manipulate the in vivo activity of most epigenetic modifying enzymes, effector molecules, etc. High-throughput small-molecule screening strategies targeted at specific epigenetic regulatory molecules could identify chemical reagents targeting a broad range of epigenetic regulatory molecules. These high impact reagents have the potential to transform the way epigeneticists conduct in vivo disease research. Contact: Dr. John Satterlee, 301-435-1020, email@example.com
06-DA-104 Development of new technologies to change patient and provider behaviors to improve adherence. New and innovative strategies to improve patient adherence to HIV/AIDS medical regimens and utilization of adherence-enhancing strategies in clinical practice would greatly enhance the health impact of efficacious treatments. This challenge invites the development of novel strategies to change patient and provider behaviors to enhance adherence to HIV/AIDS therapeutics among drug users. Contact: Dr. Jacques Normand, 301-443-1470, firstname.lastname@example.org and Thomas Hilton, Ph.D., 301- 435-0808, email@example.com, Ivan Montoya, M.D., M.P.H., 301-443-8639, firstname.lastname@example.org, Jessica Chambers, Ph.D., 301-443-2237, email@example.com.
06-DA-105 Improving health through ICT/mobile technologies. Enhancing patient compliance. ICT applications hold the prospect of dramatically improving patient health and treatment compliance in the US and abroad at greatly reduced cost. To realize these potentials, implementation research is required to identify behavior modification strategies at all levels (patient, provider and institutions) which will yield the most effective treatment outcomes using these technologies. Development and programming and feasibility testing of applications for computer and mobile devices will also be considered especially for evidence based therapies. Contact: Dr. Cecelia Spitznas, 301-402-1488, firstname.lastname@example.org and Liz Ginexi, Ph.D., 301-402-1755, LGinexi@nida.nih.gov
06-DA-106 Predictive models of potential drug addiction treatment agents. Develop predictive models of compound interactions with receptors and transporters known to be involved in drug addiction or targets for drug addiction treatment. Models developed can be intended to predict various pharmacological properties (i.e., affinity, function, toxicity, etc.). Contact: Dr. Richard Kline, 301-443-8293, email@example.com and Rao Rapaka, Ph.D., 301-435-1304, firstname.lastname@example.org
06-DA-107 Measuring the body burden of emerging contaminants: Biosensors and lab "on-chip" technology for measuring in vivo environmental agents. New advances in biosensors and lab-on-chip technology create novel ways to measure the sub-clinical health effects of second-hand and third-hand smoke in the environment. Development or field testing of the most promising environmental sensors that detect tobacco smoke combined with their use within existing epidemiologic studies are encouraged. Contact: Dr. Joni Rutter, 301-435-0298, email@example.com and Paul Hillery, Ph.D., 301-435-1306, firstname.lastname@example.org
06-DA-108 Infrastructure for biomedical knowledge discovery. Development of collaborative, research-community and concept based, integrated scientific knowledge environments to promote and accelerate articulation, discovery, exploration, discussion, testing, analysis, and sharing of hypotheses and the scientific evidence supporting them in basic neuroscience and behavioral addiction research. Contact: Dr. Karen Skinner, 301-435-0886, email@example.com
06-DA-109 Developing new computational approaches to Information Retrieval. Development of computational approaches which query multiple data sources and types relevant to basic neuroscience and behavioral addiction research, and which (1) employ or add to the Neurolex vocabulary (http://www.neurolex.org) of the NIH Blueprint Neuroscience Information Framework and (2) focus on enabling user-friendly complex queries based on concepts, anatomical coordinates, and other query parameters relevant to addiction research, that return source data elements directly within a format and context that makes them easily interpreted and accessible. Contact: Dr. Karen Skinner, 301-435-0886, firstname.lastname@example.org
06-MD-101* Development of Telehealth Tools to Promote Health and Connect At-Risk Youth to the Health System via Low-Cost, Mobile, and Wireless Technologies. NCMHD is interested in the development of telehealth messages utilizing various forms of technology, aimed at high-risk youth as well as innovative culturally and linguistically appropriate media strategies for connecting at-risk youth with the healthcare system. NIDA Contact: Dr. Jacqueline Lloyd, 301-443-8892, email@example.com, Jessica Chambers, Ph.D., 301-443-2237, firstname.lastname@example.org.
06-RR-101* Virtual environments for multidisciplinary and translational research. Virtual networking environments like Science Commons, Facebook, and Second Life, create platforms that can eliminate many barriers in scientific collaborations. These environments integrate fragmented information sources, enable "one-click" access to research resources, and assist in re-use of scientific workflows. Funded projects would develop and implement virtual collaborative environments to facilitate biomedical and translational research, e.g. addressing issues of privacy, technology transfers, and sharing resources. NIDA Contact: Dr. David Thomas, 301-435-1313, email@example.com, Bethany Deeds, Ph.D. 301-402-1935, firstname.lastname@example.org. Cecelia Spitznas, Ph.D., 301-402-1488, email@example.com.
(07) Enhancing Clinical Trials
07-DA-101 Enhancing medications development for drug addiction treatment by addressing the increasing complexity of designs, increasing costs, and regulatory hurdles of clinical trials. NIDA is soliciting grant applications focusing on strategies to enhance the success of clinical trials of medications for the treatment of drug addiction. Applications may focus on improving the design, implementation, data management, data analysis, and/or treatment outcomes to increase the chances of obtaining NDA approvals. Approaches and goals may involve but shall not be limited to the use of new technologies, electronic data capture, web-base data transmission, real-time data collection, biomarker electronic monitoring, adaptive clinical trial designs, early identification and management of safety concerns, and improvement of subject recruitment and retention in clinical trials. Contact: Dr. Ivan D. Montoya, 301-443-8639, Imontoya@mail.nih.gov
07-DA-102 Development of methodologies and scientific tools for improving and/or assessing the external validity of randomized clinical trial (RCT) results to known populations. Typically, participants in NIDA's RCTs are volunteer patients with substance abuse disorders who are seeking treatment. The fact that these patients are not randomly selected, and are recruited from non-randomly selected clinical or community settings limits the generalizability of results, a critical problem for comparative effectiveness research. Research is needed to develop scientific tools for improving and/or assessing the external validity of RCT results to known populations, including methods for applying probability sampling in the identification and recruitment of RCT participants, measuring biases in RCT participant pools, and accounting for such biases in the analysis of RCT results. Contact: Dr. Paul G. Wakim, 301-402-3057, firstname.lastname@example.org and Debbie Grossman, M.S., 301-443-2249, Dg79a@nih.gov and Belinda Sims, 301-402-1533, email@example.com
07-DA-103 Development of methodologies and scientific tools for improving and or assessing the external validity of randomized clinical trial (RCT) results to known populations. Develop a strategy utilizing existing data from substance abuse clinical trials to identify and compare the evaluation period and methodology utilized for measuring primary outcome success. Consideration should be given to both the achievement and duration of success and the optimal measurement strategy for treatment success. Explore long-term outcomes of study participants and patients in treatment to determine how the short term outcome correlates to long term results. Contact: Michele M. Straus, RPh, MS, 301-443-8888, firstname.lastname@example.org
07-DA-104 Development of methodologies and scientific tools for improving and/or assessing the external validity of randomized clinical trial (RCT) results to known populations. Often in substance abuse and HIV/AIDS research, potential participants are involved with the criminal justice system and minority groups are overrepresented; frequently they are either excluded from the studies or included in such a way that their data cannot be collected in a systematic manner. Research is needed for assessing the impact of exclusion/missing data and the external validity of RCT results to this important group of individuals with substance abuse problems and criminal justice involvement. Contact: Carmen L. Rosa, M.S., 301-443-9830, email@example.com and Richard Jenkins, Ph.D., 301-443-1923, firstname.lastname@example.org
07-DA-105 Enhanced Technologies to Monitor Illicit Drug Use Behaviors in Clinical Trials. To develop and validate new and innovative technologies that may improve the validity and reliability of data collected on illicit drug use behaviors in clinical trials. Applications may involve but are not limited to the use of technologies to enhance the quality of the report of illicit drugs and associated behaviors such as drug craving and withdrawal as well as adverse events and concomitant use of medications by participants in clinical trials. Contact: Dr. Ivan Montoya, 301-443-8639, Imontoya@mail.nih.gov and Richard Jenkins, Ph.D., 301-443-1923, email@example.com
07-DA-106 Impact of drug abuse treatments on quality of life. Research to determine the impact on quality-of-life of medications and other interventions employed to treat drug abuse, particularly in the stimulant abuse area. Validation of existing measures and techniques, and to encourage the development, improvement and/or adaptation of instruments that measure quality-of-life and cost-effectiveness of treatments employed in drug abuse research. Contact: Dr. Ivan Montoya, 301-443-8639, Imontoya@mail.nih.gov and Bennett Fletcher, Ph.D., 301-443-6504, firstname.lastname@example.org
08-DA-101 An Epigenomic "Neurochip". Individual genomic variation is likely to influence epigenomic variation significantly. One solution to the challenge of conducting epigenomic investigations into neuropsychiatric disorders could thus be to computationally identify genomic regions or single nucleotide polymorphisms in known or suspected regions of epigenomic variation. This composite data could be used to develop a "neurochip" for use in case and control studies to identify gene variants (and corresponding epigenotypic variants) important in neuropsychiatric disorders such as addiction Contact: Dr. John Satterlee, 301-435-1020, email@example.com
08-DA-102 Improved Bioinformatics Analysis for Deep Sequencing. The current estimate of sequencing an entire human genome is $5000 and can be accomplished in a few months. However, current bioinformatic and analytic capabilities are inadequate to analyze the volumes of data that would be generated by deep sequencing many individuals. Specifically, RC1 applications are sought to (1) optimize base calls from next-generation sequencing machines, (2) develop and improve optimal alignment/mapping methods that tackle uncertainty and multiple potential placements, (3) identify methods for SNP calling from multiple reads and multiple samples, (4) identify copy-number variation calling from next-generation sequencing data, and (5) develop automated methods for searching sequence databases that could be used to give probabilities that a variant is real. Contact: Dr. Jonathan D. Pollock, 301-435-1309, firstname.lastname@example.org
08-DA-103 Genetic and epigenetic predictors of symptom severity. Research on the genetic and epigenetic underpinnings of symptom severity in acute or chronic HIV-associated neurological and neurocognitive impairment, and identify individuals at greatest risk for these symptoms. Individuals with a history of substance abuse or current substance users, or SIV models incorporating substances of abuse, must be included in the analyses. Dr. Diane Lawrence, 301-443-1470, email@example.com and Joni Rutter, Ph.D., 301-435-0298, firstname.lastname@example.org
08-DA-104 Cross-disease research to identify commonly targeted pathways or mechanisms between low incidence, neurogenetic disorders with high incidence, population-based disease. Progress in treating drug addiction and related disorders has been hindered by the complex genetics and heterogeneous etiologies of these disorders. Analyzing related or clinically overlapping disorders (e.g., smoking and schizophrenia, substance abuse and conduct disorder, or poly-substance abuse) or studying rare genetic variants of large effect can yield unique biological insight into the mechanisms of underlying common diseases. Dissecting pathways common to complex genetic disorders of addiction and other neurobehavioral comorbidities will help identify potential therapeutic targets. Contact: Dr. Joni Rutter, 301-435-0298, email@example.com
08-DA-105 Beyond GWAS: Deep sequencing of mental disorders. Over the past few years, genotyping studies have identified several candidate risk genes for addiction and related disorders. Exploit new sequencing technologies that move beyond genotyping to identify rare and/or structural variants and novel risk genes for these disorders in existing DNA samples. Contact: Dr. Joni Rutter, 301-435-0298, firstname.lastname@example.org
08-DA-106 Technology and resources for high-throughput functional analysis of functional elements in genomic sequences. Develop robust, high-throughput methods to carry out functional assays to determine whether and how putative functional elements (e.g., genes and regulatory sequences) operate to determine cell states in development, health, the addicted states, and response to abused drugs. Such new methods should include both cellular and whole organism methods to allow systematic analysis of the effects of both genetic (normal variation and mutation) and environmental perturbations, and should include methods for both molecular (transcriptomic, proteomic) analysis and high-throughput phenotyping. Contact: Dr. Jonathan D. Pollock, 301-435-1309, email@example.com
08-NR-101* Genetic and Epigenetic Predictors of Symptom Severity. This initiative will support research on the genetic underpinnings of symptom severity. The findings from this research will identify individuals at greatest risk for symptoms from both acute and chronic conditions and design individualized interventions that will maximize symptom management. NIDA Contact: Dr.John Satterlee, 301-435-1010, firstname.lastname@example.org, Shoshana Y. Kahana, Ph.D., 301-443-2261, email@example.com. Kevin Conway, Ph.D., 301-443-6504, firstname.lastname@example.org, Ivan Montoya, M.D., M.P.H., 301-443-8639, email@example.com.
(09) Health Disparities
09-DA-101 Health disparities and access to participation in research. Assess the under-representation in biomedical and clinical research on HIV/AIDS of drug using U.S. minority populations, underserved populations, and populations who may be vulnerable to coercion or undue influence. Often these groups do not participate or are not adequately represented in research; however their inclusion is critical for addressing health disparities. Additionally, assess the impact and ethical considerations of conducting biomedical and clinical research on HIV/AIDS among drug using populations internationally in resource-limited countries. Contact: Dr. Lynda Erinoff, 301-443-1470, firstname.lastname@example.org and Aria Crump, Sc.D., 301-435-0881, email@example.com and Carmen L. Rosa, M.S., 301-443-9830, firstname.lastname@example.org
09-DA-102 Trans-disciplinary research to integrate the biological and non-biological determinants of health to address health disparities. Addressing HIV/AIDS health disparities in minority communities requires trans-disciplinary approaches incorporating epidemiology, ethnography, prevention interventions including: HIV testing, access to HIV/AIDS care and integration with STI and other infectious disease (hepatitis, TB) services and drug abuse treatment services. Collaborative efforts that make use of existing cohorts or other infrastructure are encouraged as are strategies that develop community infrastructure and networks, including non-traditional partnerships. Contact: Dr. Lynda Erinoff, 301-443-1470, email@example.com and Elizabeth Ginexi, Ph.D., 301-402-1755, LGinexi@nida.nih.gov, LeShawndra Price, Ph.D., 301-402-1850, firstname.lastname@example.org. Lula Beatty, Ph.D., 301-443-0441, email@example.com
09-DA-103 Initiating innovative interventions to prevent family violence. Focus on strategies to prevent family violence including domestic and intimate partner violence, and enhance behavioral efforts that build workforce infrastructure. Develop culturally and linguistically appropriate messages and tools, non-traditional methods, and marketing strategies. Explore the nature of the relationship between family violence and substance abuse. Develop and, or test strategies for prevention of, and interventions to reduce, family violence in substance using population. Contact: Dr. Petra Jacobs, 301-451-6338, firstname.lastname@example.org and Aleta Meyer, Ph.D., 301-402-1725, Meyer2@nida.nih.gov, Jessica Chambers, Ph.D., 301-443-2237, email@example.com. Belinda Sims, Ph.D., 301-402-1533, firstname.lastname@example.org.
09-DA-104 Evaluation and treatment of substance use disorders in aging populations. Research on the long-term effects of substance abuse, the clinical characteristics of aging drug abusers, and/or their age-specific substance abuse treatment needs. Research may include the evaluation of changes in cognitive abilities, behavior, psychosocial interactions, and emotional response in relation to the trajectory of drug use disorders and drug abuse treatment outcomes in older populations. Contact: Jamie Biswas, 301-443-8096, email@example.com and Karen Sirocco, Ph.D. 301-451-8661 firstname.lastname@example.org
09-DA-105 Strategies for enrollment of vulnerable or underserved patient populations in substance abuse treatment clinical trials. Identify the barriers (psychosocial, economic, familial, administrative) to enrollment of vulnerable patient populations (e.g., adolescents, pregnant women, minorities, prisoners, subjects with comorbidity of a psychiatric disorder and substance use disorder) with substance use disorders into medications development and/or behavioral treatment trials, with the purpose of finding improved enrollment, recruitment, and retention strategies. Contact: Jamie Biswas, 301-443-8096, email@example.com and Carmen L. Rosa, M.S., 301-443-9830, firstname.lastname@example.org
09-DA-106 Increase implementation of clinical research programs in the vulnerable population area of pregnant women and their in utero substance exposed neonates. Development of a standardized 'toolbox' for research implementation in this area. The research may focus on methodology, design, outcome measures, ethics, human subject protection, and recruitment in this vulnerable population to provide a platform of research feasibility. Contact: Steve Oversby, 301-435-0762 email@example.com
09-MD-101* Creating Transformational Approaches to Address Rural Health Disparities. Research will focus on approaches, partnerships, and technologies for improving rural health outcomes. In addition, NCMHD is interested in proposals that utilize innovative outreach strategies that involve collaboration among traditional and non-traditional groups including new categories of community health workers, non-traditional occupations and settings. NIDA Contact: Dr. Lula Beatty, 301-443-0441, firstname.lastname@example.org, Dionne Jones, Ph.D.,301-402-1984, Djones1@nida.nih.gov. Ivan Montoya, M.D., M.P.H., 301-443-8639, email@example.com. Cecelia Spitznas, Ph.D., 301-402-1488, firstname.lastname@example.org.
(10) Information Technology for Processing Health Care Data
10-DA-101 Dynamic Simulations of Drug Abuse. Dynamic Simulation Models are being used in many fields to reduce the resource burden of research, to maximize the use of collected data, and to combine and consider the interaction of findings from multiple sources. The development of drug abuse simulations may be useful in a wide variety of situations including the screening of pharmacological compounds, the development of enhanced computational algorithms to increase the predictive validity of animal models, for facilitating the adoption of interventions, to more effectively tailor interventions for special populations and newly emerging abusable drugs and drug use patterns, for the exploration of the impact of policy changes, cultural and public health developments, and to improve the anticipation of epidemiological trends. Contact: Dr. Tom Hilton, 301-435-0808, email@example.com and Steven Grant, Ph.D. 301-443-4877 firstname.lastname@example.org
10-DA-102 Development of innovative information and communication technology (ICT) to enhance capabilities of U.S. institutions in global health research and research training. Drug use is a global problem and driving the HIV epidemic in many developing and transitional countries. Widespread implementation of effective drug treatments and HIV risk reduction interventions targeting drug users is an urgent priority. This initiative encourages the development of innovative strategies for rapid refinement, dissemination, and expansion of drug treatment and HIV risk reduction interventions using ICT targeting the specific local circumstances and cultures of drug users in developing and transitional countries. Contact: Dr. Jacques Normand, 301-443-1470, email@example.com and Richard Jenkins, Ph.D., 301-443-1923, firstname.lastname@example.org
10-DA-103 Data warehouse of drug abuse pharmacotherapy clinical trials. Creation of a database system for entry of efficacy as well as safety data from drug abuse clinical trials that will facilitate the analysis of data across multiple clinical trials that have evaluated multiple medications. Contact: Dr. Ivan Montoya, 301-4435-8631 Imontoya@mail.nih.gov
10-OD-101* Adapt existing genetic and clinical databases to make them interoperable for pharmacogenomics studies. In order for personalized approaches to drug therapy to be developed, genetic data and clinical data need to be superimposed. Analysis of the superimposed data will generate hypotheses concerning genetic control of drug efficacy. Contact: Dr. Joni Rutter (NIDA), 301-435-0298, email@example.com
(13) Smart Biomaterials - Theranostics
13-DA-101 Theranostics: Combined delivery of diagnostic and therapeutic agents for drug abuse/HIV research/treatment. Development of novel, nanotechnologically-based multimodal imaging approaches (e.g. optical, MR) to deliver combined diagnostic and therapeutic agents to (appropriate) targeted sites with high specificity and in adequate concentrations to realize the promise of combined diagnosis and treatment of drug abuse and HIV/AIDS in a single sitting ("theranostics"). Contact: Dr. Thomas Aigner, 301-435-1314, firstname.lastname@example.org
13-DA-102 Methods to evaluate the health and safety of nanomaterials. Develop novel tools and approaches to determine the impact on biological systems and health outcomes of an array of engineered nanomaterials used to study drug abuse and HIV/AIDS. Conduct biological, physical and chemical characterization of selected nanomaterials to aid in setting standards for health and safety, and developing computational models for the prediction of long-term secondary effects. Contact: Dr. Thomas Aigner, 301-435-1314, email@example.com
(14) Stem Cells
14-DA-101 Generating human neurons with iPS to screen and develop bioactive agents for the treatment of nicotine addiction. Studies are encouraged that use iPS cells for the induction of dopaminergic neurons and other cortical neurons, for the screening and development of bioactive agents for the treatment of nicotine addiction. iPS cells will be generated from addicts and individuals who have been exposed to drugs of abuse but have not become addicted, for biological responses that are genome and genetic specific. In addition, other tissues such as liver, heart, kidney and lung will also be generated to screen for drug toxicity. Contact: Dr. Jonathan D. Pollock, 301-435-1309, firstname.lastname@example.org
14-DA-102 Generating germline-competent ES cells for rodent strains. The generation of germline-competent ES cells ES cells from many rat and mouse inbred strains has been problematic. This has made the generation of targeted mutations in different genetic background difficult and has prevented the creation of better animal model of disease. Furthermore, ES cell panels, with their broad differentiation potential, are powerful tools for performing complex genetic experiments in vitro. Thus, the development of germline-competent ES cells using iPS or other technologies for different rodent strains is requested. Contact: Dr. Jonathan D. Pollock, 301-435-1309, email@example.com
14-DA-103 Developing iPS cells for addiction and co-morbid mental disorders. NIDA seeks applications that characterize the physiological response of neurons and glia derived from induced pluripotent stem cells from individuals with addiction and co-morbid mental disorders (autism, schizophrenia, mood disorders). Contacts: Dr. Jonathan D. Pollock, 301-435-1309, firstname.lastname@example.org and Dr. Geraline C. Lin, (301) 435-1305 email@example.com
14-DA-104 Exploratory studies of induced pluripotent stem (iPS) cells from healthy individuals and patients with mental/nervous system disorders. NIDA seeks to support studies that generate and characterize neurons and glia derived from iPSCs from individuals addicted to drugs and controls. Research topics can include maximizing derivation efficiency, maintenance, or reproducibility, studies of cellular differentiation, screening bioactive agents, or profiling the molecular signature as well as the functional properties of cells from controls vs patients. There will be an emphasis on appropriate validation of iPS cells and their derivatives, evaluating the hetero/homogeneity of any cell populations to be screened and use of cellular assays relevant to normal development, organ function and disease. Contacts: Dr. Jonathan D. Pollock, 301-435-1309, firstname.lastname@example.org and Dr. Geraline C. Lin, (301) 435-1305, email@example.com
14-DA-105 Induced pluripotent stem cells: Cellular and humanized mouse models of disease. Studies are encouraged that use iPS cells for the induction of dopaminergic neurons and other cortical neurons, for the screening and development of bioactive agents for the treatment of nicotine addiction. iPS cells will be generated from addicts and individuals who have been exposed to drugs of abuse but have not become addicted, for biological responses that are genome and genetic specific. In addition, other tissues such as liver, heart, kidney and lung will also be generated for functional genomics and for drug toxicity screens. Contacts: Dr. Jonathan D. Pollock, 301-435-1309, firstname.lastname@example.org and Dr. Geraline C. Lin, (301) 435-1305, email@example.com
14-DA-106 Induced-Pluripotent Stem Cells (iPS) and Cellular Reprogramming Technology in Drug Abuse and Addiction. Induced pluripotent stem (iPS) cells and cellular reprogramming technology will be used to define the pathophysiology of drug abuse and addiction, including drug-induced neurotoxicity. The knowledge gained will be utilized to repair/restore functions, develop treatment drugs, screen drug toxicity, replace defected cells (where damages are beyond repair/restoration), and make disease diagnosis. Contact: Dr. Geraline C. Lin, (301) 435-1305, firstname.lastname@example.org
(15) Translational Science
15-DA-101* Novel Approaches to Improve Immunogenicity of Vaccines Against Small Molecules. Innovative approaches to enhance the immunogenicity of small molecules (e.g., toxins, carcinogens, influenza epitopes, drugs of abuse) could lead to revolutionary advances in our ability to preempt, minimize the impact, or help reverse the course of preventable diseases. These approaches may leverage a variety of research strategies, including nanoparticle technology, hapten-tagging of virus-like particles, synthetic adjuvant systems, and novel immunomodulators and delivery systems. Contact: Dr.Nora Chang, 301-443-5280 or 301-443-8099, email@example.com
15-DA-102 NIH partners in research program: Pathways for translational research. Develop strategies for dissemination of interventions with demonstrated effectiveness for translation into clinical practice by teams of academic and community research partners. The National Drug Abuse Treatment Clinical Trials Network (CTN) fosters collaborative relationships between academic investigators and front-line community-based substance abuse treatment providers. This well-established network provides a fertile platform for quick-turnaround projects that can advance knowledge on rapidly moving scientific findings into communities to improve health. Contact: Dr. Harold I Perl, 301-443-9982, firstname.lastname@example.org and Belinda Sims, Ph.D., 301-402-1533, email@example.com, Elizabeth M. Ginexi, Ph.D., 301-402-1755, LGinexi@nida.nih.gov. Ivan Montoya, M.D., M.P.H., 301-443-8639, firstname.lastname@example.org. Debbie Grossman, M.S., 301-443-2249, Dg9a@nih.gov.
15-DA-103 Development and Testing of Clinical Practice Algorithms to Improve Quality and Outcomes of Substance Abuse Treatment. In recent years, many efficacious substance abuse treatment interventions, both pharmacotherapeutic and behavioral, have been developed and validated, and subsequently adopted into clinical practice. However, treatment providers still face a lack of evidence to guide decisions on choosing treatment approaches for individual patients, combining or sequencing interventions, particularly for patients with co-occurring substance use and other mental health disorders, and identifying optimal "rescue" treatments when an initial intervention fails. Research on these questions is needed to facilitate the development of clinical practice algorithms that can guide providers' decision-making and ultimately improve the quality and outcomes of substance abuse treatment. Contact: Dr. Petra Jacobs, 301-451-6338, email@example.com and Thomas Hilton, Ph.D., 301- 435-0808, firstname.lastname@example.org
15-DA-104 Intervention Providers, Settings, and Pragmatic Constraints. Successful implementation of empirically supported preventive programs and treatments is dependent on multiple factors, but some of which are related to the characteristics of the intervention work force, the nature of the intervention settings, and the practical limitations working against optimal intervention utilization. Well documented national information is not available nor are more local characterizations. This program would determine the characteristics of the treatment work force and prevention providers, characterize the settings and organizations providing interventions, and identify major impediments to program adoption and implementation. Examples of implementation barriers might include competing demands in school settings, inadequate specialized treatment facilities in some areas, etc. Approaches to overcoming the successful adoption of effective evidence based interventions would be determined as part of the expected scope of this program. Contact: Dr. Lori J. Ducharme, 301-443-2279, Lori.Ducharme@nih.gov, Ivan Montoya, M.D., M.P.H., 301-443-8639, email@example.com.
15-DA-105 Manipulating the blood-brain barrier to deliver CNS therapies for mental/nervous system disorders. Substance abuse has been shown to impact the neurological, behavioral, and neurocognitive consequences of HIV infection. A variety of strategies, including use of antiretroviral, anti-inflammatory, and/or neuroprotective therapeutics, have been proposed as potential treatments for neuroAIDS, but delivery of potentially effective agents across the blood-brain barrier remains a hurdle. This initiative is aimed at developing potentially useful CNS drug targeting and delivery systems that will be effective in the context of substance abuse. Contact: Dr. Diane Lawrence, 301-443-1470, firstname.lastname@example.org and Rao Rapaka, Ph.D., 301-435-1304, email@example.com
15-DA-106 Exploring the earliest events in HIV infection and use this information to develop new interventions for preventing and treating HIV infection. Substance abuse is a major cofactor in HIV/AIDS. Early events in HIV infection are important for establishing the rate of progression to AIDS and possibly the development of neurologic and neurocognitive impairment. There is a need to understand how substance abuse affects the earliest stages of HIV infection and pathogenesis in order to identify new targets for interventions. Dr. Diane Lawrence, 301-443-1470, firstname.lastname@example.org and Raul N. Mandler, M.D., 301-435-0645, email@example.com and Richard Jenkins, Ph.D., 301-443-1923, firstname.lastname@example.org and Woody Lin, Ph.D. 301 435-1318 email@example.com
15-DA-107 The identification, validation, and exploitation of new molecular targets for the treatment of drug addiction disorders. Projects may utilize techniques ranging from gene knockout technologies, behavioral evaluations, assay development, and targeted library synthesis and screening that could lead to the development of medications for drug addiction treatment. The focus may be on the identification of new molecular targets, and/or the discovery of small molecule selective ligands for previously identified targets, such as muscarinic M5 antagonists, neuropeptide Y antagonists, and neurotensin agonists. Contact: Jane B. Acri, 301-443-8489, firstname.lastname@example.org
15-DA-108 Developing approaches for presenting relevant genomic information in an understandable way, in the context of a patient's electronic health record. As data becomes available on drug abuse and addiction genetics, these data must eventually be integrated into electronic health records in ways that help clinicians and patients to understand the significance of the data. There is a need to provide an avenue for alerting clinicians and patients when new knowledge from basic and clinical research arises to the level of potential clinical impact; and enable linking to effective decision support and treatment implementation. Contact: Dr. Joni Rutter, 301-435-0298, email@example.com
15-DA-109 Effects of environmental exposures on phenotypic outcomes using non-human models. Environmental effects mediated thru the central nervous system (especially via the HPA axis) can affect drug abuse behavior and the development of addiction. These exposures may include prenatal drug effects, physical and social stressors, and epigenetic or neurobiological consequences of early adverse experiences. How these exposures change nervous system structure and function to influence drug abuse behavior and the development of addiction is of interest. Contact: Dr. Minda Lynch, 301-435-1322, firstname.lastname@example.org
15-DA-110 Determining if and how adolescent behaviors affect connections in the developing brain. Research is needed to understand how drug abuse during adolescence affects stem cell and progenitor cell induction, myelination, programmed cell death, guidance of glial and neuronal migration, and regulation of dendritic and axonal outgrowth, navigation, target selection, and synapse formation in the nervous system. Contact: Dr. Da-Yu Wu, 301-435-4649, email@example.com, Lula Beatty, Ph.D., 301-443-0441, firstname.lastname@example.org. Ivan Montoya, M.D., M.P.H., 301-443-8639, email@example.com. Karen Y. Sirocco, Ph.D., 301-451-8661, Sirocco@nida.nih.gov. James Bjork, Ph.D., 301-443-3209, firstname.lastname@example.org.
15-DA-111 Manipulating the blood-brain barrier to deliver CNS therapies for mental/nervous system disorders. Methods to deliver peptide/peptidomimetic drugs to CNS, develop drugs that pass blood brain barrier but do not pass through the placental barrier, use of nanotechnology based methodologies for CNS delivery, methods to deliver drugs only through placental barrier but do not cross the BBB, innovative in-vitro models to predict BBB and placental barrier. Contact: Dr. Rao S. Rapaka, 301-435-1304, Rr82u@nih.gov
15-DA-112 New models and measures in pre-clinical chronic pain research. Existing animal models of pain conditions inadequately reflect the pathology or the phenotypes of the human state. New animal models to study the transition from acute to chronic pain are needed. These could include new functional and behavioral assays of acute and chronic pain. Further, it is important to characterize the impact of analgesics of various classes in these pain models. Of special interest is identifying when drugs without abuse potential (e.g. NSAIDS) are of comparable or better efficacy in attenuating or stopping the transition to chronic pain. Contact: Dr. David Thomas, 301-435-1313, email@example.com, Ivan Montoya, M.D., M.P.H., 301-443-8639, firstname.lastname@example.org.
15-RR-101* Applied translational technology development. This program will support two-year applied translational projects to move advanced technologies from the prototype stage into the clinic. Novel, cost-effective tools for clinical care or clinical research will be modified, hardened, and tested. Interdisciplinary teams of technology developers, basic researchers and clinicians will address scientific and engineering problems associated with clinical applications of new technologies. NIDA Contact: Dr. Kris Bough, 301-443-9800, email@example.com, Ivan Montoya, M.D., M.P.H., 301-443-8639, firstname.lastname@example.org
For general information on the National Institute on Drug Abuse implementation of NIH Challenge Grants, contact:
Christine Colvis, Ph.D.
NIDA Challenge Grant Program Coordinator
National Institute on Drug Abuse
National Institutes of Health
For Financial or Grants Management questions, contact:
Pamela G. Fleming
Chief Grants Management Officer
National Institute on Drug Abuse
National Institutes of Health
Phone: (301) 253-8729