Skip Navigation

Link to  the National Institutes of Health  
The Science of Drug Abuse and Addiction from the National Institute on Drug Abuse Archives of the National Institute on Drug Abuse web site
Go to the Home page
   
NIDA Home > Recovery > Supplements > Limited Competition for Revision Applications

American Recovery and Reinvestment Act of 2009 (Recovery Act)

NIH Announces Recovery Act - Limited Competition for Revision Applications
(NOT-OD-09-058)
National Institute on Drug Abuse

The National Institutes of Health (NIH) announces the opportunity for investigators and United States institutions/organizations with active NIH-supported research project grants to submit revision applications (formerly termed competitive supplements) to support a significant expansion of a project's scope or research protocol of approved and funded projects. Support for these revision applications will come from funds available through the American Recovery and Reinvestment Act of 2009 ("Recovery Act"), Public Law 111-5. The deadline for receipt of these revision applications is April 21, 2009.

This initiative is one of several being offered by NIDA to help fulfill the goals of the American Recovery and Reinvestment Act (ARRA) to help stimulate the economy through support of biomedical and behavioral research. Additional information the Recovery Act and related NIH opportunities is available through the Office of Extramural Research http://grants.nih.gov/recovery/

Areas of Scientific Priority:

NIDA considers the following scientific areas high-priority although revision applications in other areas will also be considered:

General Information


Medications and Immunotherapies

The development of safe and effective medications to treat substance related disorders (SRDs) is a top priority of NIDA. Through this FOA, NIDA is soliciting revision applications for existing preclinical and clinical grants focused on medications development, to enhance and accelerate the discovery and development of new medications for the treatment of SRDs.

The purpose of this FOA is to fund new studies to existing grants. While all revisions proposing new medications development projects could be considered responsive to this FOA, revisions to grants proposing the development of small molecules and enzyme-based therapies as new pharmacotherapies, and to grants proposing the development of immunotherapies, such as vaccines or monoclonal antibodies, are of particular interest, as are pilot studies.

Topics of interest include, but are not limited to, the following:

  • Novel approaches for the design and synthesis of new medications, including small molecules, enzyme-based therapies, highly immunogenic vaccines, and monoclonal antibodies.
  • Scale-up production of experimental vaccines or monoclonal antibodies
  • Characterization of the immunogenicity of vaccines and monoclonal antibodies.
  • Development of drug delivery systems for new medications.
  • Mechanistic studies of the pharmacokinetics and pharmacodynamics of new pharmacotherapies, including effects of immunotherapies and enzyme-based therapies on the pharmacokinetics of drugs of abuse.
  • Development and selection of hapten-carrier adducts or adjuvants that improve the immunogenicity of immunotherapies.
  • Preclinical evaluations of vaccines or monoclonal antibodies in different species and under different paradigms of substance-use or -induced disorders.
  • Preclinical evaluation of the toxicity and teratogenesis of new medications..
  • Relevant animal models to evaluate the efficacy of the new medications in attenuating the behavioral and/or physiological effects induced by drugs of abuse.
  • Studies required for the IND-targeted preclinical development (GMP synthesis, formulation, toxicology, and pharmacokinetics) of proposed candidate new medications.
  • Human laboratory (Phase I) studies of the safety and preliminary efficacy of new medications.
  • Development and testing of human laboratory models to evaluate the effects of immunotherapies or novel pharmacotherapies on discrimination, self-administration, reward, craving, withdrawal, and physiological dependence.
  • Interaction studies in humans focused on the effects of immunotherapies or pharmacotherapies and the concurrent use of targeted drugs of abuse, including pharmacokinetic and/or pharmacodynamic studies.
  • Randomized clinical trials, defined by FDA as Phase II, to evaluate the safety and/or efficacy of immunotherapies or pharmacotherapies for the treatment of substance use or induced disorders or any of their specific symptoms. For example, studies may focus on the treatment of drug dependence in general or specifically on drug withdrawal.
  • FDA-defined Phase III clinical trials of immunotherapies or pharmacotherapies which have shown efficacy in Phase II clinical trials.
  • Testing the safety of immunotherapies or pharmacotherapies in individuals with other concurrent medical conditions such as but not limited to allergies or immunosupression.
  • Testing the safety or efficacy of immunotherapies or pharmacotherapies in individuals who represent underserved patient populations with SRDs (e.g., pregnant women and their neonates, adolescents, minorities, patients with a comorbidity of SRDs and psychiatric disorders, subjects in the criminal justice system).

When considering the appropriateness of a revision application in response to this FOA, it is important to take into account that completion of the work proposed must be feasible within a period of two years.

In general, you should contact the PO of the parent grant. If you do not know who your PO is, you may contact: Jamie Biswas jb168r@nih.gov 301-443-8096


Biomarkers of Chronic Drug Use

Revision applications for ongoing animal or human research may be requested to search for "peripheral" biomarkers (not the drug itself or its metabolites) to determine if exposure to drugs of abuse, acutely or chronically, occurred in the recent past (empirically determined), in the absence of the drug itself or its metabolites at the time of sample collection. A secondary aim is to determine whether these "peripheral" biomarkers could serve as surrogates for changes that are taking place in the brain resulting from drug exposure, withdrawal or relapse. The biomaterials selected must be clinically accessible (e.g., blood, lymphocytes, bladder epithelial cells, stem cells). Research should be directed at identifying the best class or classes of molecules (proteins, peptides, RNA, miRNA, etc.) suitable for assay development. Projects exploring the feasibility using in silco predictions will also be considered. The overall goal in this priority area is to address technical issues such as sensitivity and signal-to-noise ratio, in addition to predictive validity of the putative biomarkers selected and studied.

In general, you should contact the PO of the parent grant. If you do not know who your PO is, you may contact: Elena Koustova 301-496-8768 koustovae@nida.nih.gov or Rao Rapaka 301-435-1304 rrapaka@mail.nih.gov


Genetics and Epigenetics

Areas of interest in genetics and epigenetics include but are not limited to:

  • Epigenetic Modifications of DNA and Chromatin produced by environmental stimuli.
  • Analysis of non-coding RNAs.
  • Meta-analysis of GWAS and family data for smoking associated phenotypes.
  • Competitive supplements for genotyping human phenotypes associated with drug abuse and addiction phenotypes.
  • Bioinformatic and statistical analysis of genetic data including gene expression and gene mapping studies.
  • The creation and generation of knockouts, knockins, and conditional knockouts in mice. Priority will be given to requests using the NIH knockout project resource (www.komp.org) if the requested knockout alleles are available in the resource.
  • Generation and characterization of induced mutation in rats.
  • Develop tissue specific drivers of gene expression for driving tissue specific expression of recombinases and other transgenes.
  • Map genetic loci for addiction relevant phenotypes in model genetic organisms.
  • Screening existing rodent strains for addiction relevant phenotypes.
  • Genotyping and/or deep sequencing drug abuse and addiction phenotypes.
  • Accelerate the recruitment of subjects for human genetic studies on addiction.

In general, you should contact the PO of the parent grant. If you do not know who the PO is, you may contact: Joni Rutter 301-435-0298 jrutter@nida.nih.gov or Jonathan Pollock 301-534-1309 jpollock@mail.nih.gov


Comorbidity

Drug-use disorders frequently co-occur with other substance-use disorders, with other psychiatric disorders, and with many medical disorders. This comorbidity has implications for basic, clinical, and population-based research on the etiology, course, and consequences of drug use disorders, prevention, treatment and service delivery. Approaches to enhance our understanding of the impact of comorbidity include the addition of subjects, measures, data analyses and pilot interventions to ongoing studies on human subjects and animal models. Revision applications are welcomed for gap areas that include, but are not limited to, the following:

Addition of subjects:

  • add subjects with polysubstance use to studies of single drug use disorders
  • add comorbid subjects to already existing clinical trials to examine the efficacy of the treatment for comorbid populations
  • in animal studies of drug abuse, add strains or genetically altered animals with characterized phenotypes that correlate with dimensions of other mental disorders

Additions to data collection:

  • add measures of personality disorders and internalizing disorders (such as generalized anxiety or post-traumatic stress disorder) to epidemiologic studies
  • add measures of use of and dependence on legal substances, particularly caffeine and prescription drugs, to epidemiologic or etiologic studies
  • add the collection of genetic material to epidemiologic studies to enhance understanding of gene-environment interplay in drug abuse etiology
  • add measures of service use, cost, cost effectiveness, organizational characteristics or psychosocial parameters (e.g. criminal activity, employment, stable housing, structural environment) to ongoing preventive intervention or treatment studies of comorbid drug use and psychiatric disorders
  • add assessments of psychiatric disorders, suicide, trauma or psychosocial risk factors to HIV and substance abuse prevention studies
  • add measures of emerging drugs within ongoing epidemiologic and prevention studies
  • in human or animal studies of individual differences in drug abuse vulnerability, resistance to extinction, or reinstatement, add behavioral or neurobiological measures that capture dimensions of other mental disorders
  • gather data to identify why individuals with comorbid psychiatric or medical conditions may fail (e.g., drop out/relapse) during evidence based treatments (via measures, focus groups, ecologically valid momentary assessment)
  • investigate the effects of comorbid medical conditions (e.g. infection) in animal models of drug abuse
  • in cellular or molecular studies of drug abuse, add measures known or thought to correlate with other mental disorders
  • gather genetic data in order to identify specific genetic variants that may moderate response to various behavioral or pharmacological treatments for comorbid populations

Additional analyses

  • analyze previously collected dimensional data in the etiology of drug abuse
  • examine long-term effects, crossover effects, and mediators of effective prevention programs to address co-morbidities (e.g., HIV-related behaviors, psychiatric co-morbidity, other drugs, and medical conditions, including obesity)
  • analyze data to identify specific mechanisms of action for behavioral and/or integrative treatments for comorbid conditions
  • cost-effectiveness analyses for treatments that target comorbid conditions
  • analyze the effects of co-morbid symptoms on adherence to behavioral or integrative treatments
  • analyze associations and temporal relationships between medical/health conditions and drug use

Addition of a pilot intervention within the scope of the parent grant

  • add a booster component for youth at high risk for HIV exposure
  • add a sibling intervention component to HIV/substance abuse prevention studies for at risk youth
  • pilot test Stage 1 interventions for comorbid conditions
  • develop Stage III translational work with community treatment providers to examine feasibility of adding evidence based treatment for the comorbid condition

In general, you should contact the PO of the parent grant. If you do not know who your PO is, you may contact: Susan Volman svolman@nida.nih.gov 301-435-1315 or Naimah Weinberg nweinber@nida.nih.gov 301-443-6504


Sex/Gender Differences

Many NIDA-funded studies report outcomes separately for males and females; however, this is not the norm. Yet, among studies in which such analysis is provided, there are often reports of outcomes that are limited to either males or females and outcomes that are opposite in males and females. These cases raise questions about outcomes in other studies in which analysis of data by sex/gender is not performed. To address this issue and to foster the conduct of sex/gender analyses in NIDA-supported research, under this solicitation for revision applications, NIDA grantees are invited to submit revision applications for any of the following three types of investigations.

  • Animal Models. Most of NIDA-supported animal research is conducted only with male subjects. Yet, there is a growing animal model literature indicating that when drug abuse researchers compare male and female subjects, sex differences frequently are observed. Additionally, research has begun to examine the hormonal, pharmacokinetic, neurobiological, organizational, and genetic bases of these differences. This approach is necessary in order to determine whether current models of the biological and behavioral mechanisms of drug abuse, based on males, applies to females. Under this solicitation, grantees may request funds to conduct studies in females that are parallel to those proposed for males in order to assess whether there are comparable outcomes in males and females. Finding differences could then serve as the basis to further explore those outcomes in subsequent grant applications.
  • Under-powered Human Subjects Studies. For many NIDA-funded studies, testing for sex/gender differences is precluded because the proposed study sample is too small to test for statistical differences. A revision application, therefore, can be requested for the purpose of recruiting and testing additional subjects so as obtain sufficient statistical power to permit a gender analysis of outcomes.
  • Secondary Data Analyses. Investigators who have data sets, either completed or in progress, for which there is statistical power for a sex/gender analyses, but for which such analyses were not proposed in the parent grant, may request funds to test for sex/gender differences. Such requests are appropriate only when there is clear justification for why the resources of the parent grant are insufficient to fund the proposed work.

The primary aim of this Notice is to advance knowledge on sex/gender differences in drug abuse by increasing the number of NIDA grants in which a sex/gender analysis of data is conducted.

The following additional requirements must be met and will be considered in the review of the request: (a) Provide a brief review of sex/gender differences literature that is relevant to drug abuse and why it suggests the need to conduct a sex/gender data analyses in the parent grant. (b) Set forth specific hypotheses regarding sex/gender differences and provide rationale for the hypotheses. (c) Describe how taking a sex/gender-based approach will further the aims and significance of the parent grant. (d) In the case of secondary data analysis, provide justification for why the resources of the parent grant are insufficient to fund the required work.

In general, you should contact the PO of the parent grant. If you do not know who the PO is, you may contact: Cora Lee Wetherington cwetheri@mail.nih.gov 301-435-1319


Health Disparities

Eliminating disparities in health continues to be a national priority as efforts to reduce disparities have met with mixed results (e.g., see Healthy People 2010: Midcourse Review Executive Summary). The purpose of this solicitation for revision applications is to give NIDA-funded researchers the opportunity (1) to recruit additional study participants, or (2) to expand analyses of existing samples, measures or procedures which already have sufficient representation from various racial/ethnic minority populations. This will allow investigators to assess patterns of drug use, effects and potential adverse behavioral, social and health consequences; ascertain prevention and service strategies and interventions most efficacious or effective for specific groups within health disparity population groups; and determine differential treatment outcomes within and across racial/ethnic minority populations.

Research areas and analyses of strong interest to NIDA include the following:

  • HIV/AIDS: Racial/ethnic disparities in HIV testing and access and utilization of treatment and services; prevention interventions among drug users involved in the criminal justice system; intervention strategies to coordinate and improve treatment and services for HIV, drug abuse, and co-occurring conditions (e.g., HCV); and research on structural interventions to prevent HIV/AIDS transmission and/or to enhance access/utilization of treatment and services.
  • Specific population groups: Groups chronically underrepresented in current drug abuse research include American Indians, Alaska Natives, Native Hawaiians, Pacific Islanders and Asian Americans. Other groups of interest include MSM, rural dwellers, and immigrant/migrant/border populations.
  • Conducting analyses within racial/ethnic population groups to determine factors (e.g., gender, age, socioeconomic status, country of origin, geographical location) contributing to differential experiences and outcomes related to drug use and prevention, intervention and treatment approaches.
  • Conducting research on the influence of cultural factors on recruitment, participation, retention, community involvement, measures, and prevention, services and treatment approaches and outcomes.
  • Impact and outcome of discrimination on treatment delivery and patient care

NIDA strongly encourages the employment and participation of underrepresented scholars in the supplemental work proposed.

In general, you should contact the PO of the parent grant. If you do not know who the PO is, you may contact: Lula Beatty lbeatty@nida.nih.gov 301-443-0441


Detection of CNS Impairment

Despite the broad success of current HAART therapy, neurocognitive impairment and other central nervous system (CNS) manifestations of HIV disease remain prevalent. A large proportion of HIV-infected individuals have a history of licit or illicit drug use, and little is known about how drug use affects HIV-associated CNS impairment. Moreover, early events in HIV infection that are important for establishing viral set point and rate of progression to AIDS may also impact development of CNS impairments. CNS impairment is important because it affects quality of life and may lead individuals to engage in behaviors associated with HIV transmission (e.g., poor HAART adherence, risky decision making).

This initiative solicits revision applications to detect/assess CNS effects of substance abuse and HIV/SIV infection. Proposals should include well-characterized populations (i.e., information on drug use, HCV coinfection, and other comorbidities) or established non-human primate models. Examples of proposed areas of study include but are not limited to:

  • Studies to detect or predict CNS impairments based on acute events in HIV/SIV infection.
  • Studies to develop behavioral indices and/or biomarkers of CNS impairment to streamline diagnosis and monitor HIV-associated CNS impairment.
  • Studies that would support investigators with HIV+ subjects to add measures of decision making or enable investigators studying decision making to add HIV+ subjects.

To examine developmental effects (e.g., are CNS impairments similar for adults and adolescents with early HIV infection?)

In general, you should contact the PO of the parent grant. If you do not know who the PO is, you may contact: Steven Grant, sgrant@nida.nih.gov 301-443-4877 or Yu "Woody" Lin ylin1@mail.nih.gov 301-435-1318


Additional Guidance

All applications must address ARRA justifications, including how the revision is expected to stimulate the economy by:

  1. enabling hiring of additional staff;
  2. enabling increased hours of current part-time staff;
  3. procuring additional needed equipment (costing under $100,000); and/or
  4. contracting for additional needed skills.

Include a timeline demonstrating that the proposed research can be completed within the requested period of support not to exceed two years.

Include with the revision application, a current Human Subjects/IRB or Vertebrate Animals/IACUC approval letter as appropriate

Funding Priorities:

Applicants interested in applying for Revision support under a program (activity code) that has already transitioned to electronic submission must submit the application through Grants.gov, using the Funding Opportunity Announcement (FOA) that was used for the parent grant. Or, if this FOA is no longer active, use the Parent FOA that matches the program (activity code) of the award.

Applicants interested in applying for Revision support under a program (activity code) that has already transitioned to electronic submission must submit the application through Grants.gov, using the Funding Opportunity Announcement (FOA) that was used for the parent grant. Or, if this FOA is no longer active, use the Parent FOA that matches the program (activity code) of the award.

  • The activity code (e.g., R01, R37 (use R01 FOA)) of the prior submission (referenced by the Federal Identifier on the SF 424 RR Cover page) must match the activity code of the FOA used for the revision. Revision applications for conference grants (R13) are not permitted.
  • For revisions to Program Project Grants, cooperative agreements and center grants(e.g., P01, U01, U10, U19, P30, P50, P60) submitted in paper, an FOA is not required. This Notice (NIH-OD-09-058) should be mentioned in the cover letter.
  • For all other eligible activity codes that have transitioned to electronic submission, use the following chart to identify the appropriate Parent FOA under which to submit through Grants.gov if the original FOA has expired:
Activity CodeProgramFOA
R01Research Project Grant (Parent R01)PA-07-070

Note: Paper applications will not be accepted for activity codes that have transitioned to electronic submission.

The following types of grants (activity codes) will not be accepted by NIDA:

  • U24, R24, R25, R41, R42, R43, R44, T32, F30, F31, F32, all K's except for K99

Application Receipt Dates for Revision Applications:

Date (s) in FY 2009: April 21, 2009

Contact Information:

In general, if you have questions, you should contact the PO of the parent grant.

Grants Management Contact: Carol Alderson, 301-594-5614 ca10h@nih.gov

Additional Resources



Archive Home | Accessibility | Privacy | FOIA (NIH) | Current NIDA Home Page
National Institutes of Health logo_Department of Health and Human Services Logo The National Institute on Drug Abuse (NIDA) is part of the National Institutes of Health (NIH) , a component of the U.S. Department of Health and Human Services. Questions? See our Contact Information. . The U.S. government's official web portal