Release
Date: March 7, 2011
Receipt Date: April 29, 2011
Earliest Anticipated
Start Date: July 1, 2011
National Institute on Drug Abuse (NIDA)
The National Institute on Drug Abuse announces an administrative supplement program to provide funds to support research on whether reductions in cocaine use due to cocaine addiction treatment lead to improvements in meaningful clinical outcomes.
Many view abstinence as the ultimate objective of drug addiction treatment. However, the current conception of cocaine addiction as a chronic brain disease that may remit and relapse over time and that can affect many areas of psychosocial functioning calls into question whether sustained cocaine abstinence is the only beneficial goal of treatment. In particular, if a treatment-induced reduction in cocaine use is also beneficial in clinically meaningful ways, then failure to consider that as an important treatment outcome in intervention trials may unnecessarily restrict the availability of approaches that may improve public health. Although intuitively appealing, the scientific evidence relating treatment-induced reductions in cocaine use to beneficial outcomes, particularly in the long term, is scant.
A variety of study designs and data sources may be considered responsive to this notice. For example, studies encompassing rigorous, secondary analyses of existing longitudinal data sets containing repeated measures of cocaine use quantities and frequencies as well as long-term treatment outcomes, and that employ advanced statistical methods to control for confounders and support causal inferences, may be appropriate. Similar studies using shorter duration clinical trials data or examining in-treatment samples may also be appropriate. In addition, studies examining the magnitude of the reduction in use necessary to effect clinically meaningful benefits, as well as studies that seek to develop improved methods for informing this question, may also be appropriate.
NIDA anticipates committing a total of $500,000 for all
projects selected through this announcement in Fiscal Year 2011.
Supplement requests must be for less than $100,000 in total costs.
This announcement is for supplements to NIDA-Funded P01, R01, R21, R34 U01, and
U10 research projects.
To be
eligible, the parent grant must be active through at least October 1, 2012, and
the research proposed in the supplement must be accomplished within the
competitive segment. The proposed supplement must be within the general scope
of the peer-reviewed activities and aims approved within the parent grant.
IMPORTANT: The research proposed by the NIH grantee in the supplement
application must be within the original scope of the NIH-supported grant
project. The funding mechanism being used to support this program,
administrative supplements, can be used to cover cost increases that are
associated with achieving certain new research objectives as long as they are
within the original scope of the project. Any cost increases need to result
from making modifications to the project in order to take advantage of
opportunities that would increase the value of the project consistent with its
originally approved objectives and purposes.
Investigators
who are interested in pursuing this line of research using existing data
sources but who are not eligible under this announcement may wish to consider
applying for a research project grant under PAR-10-018, Accelerating the Pace
of Drug Abuse Research Using Existing Epidemiology, Prevention, and Treatment
Research Data (R01) which can be found here: https://grants.nih.gov/grants/guide/pa-files/PAR-10-018.html.
To be considered for an administrative supplement, the request must be signed by the Authorized Organizational Representative/Signing Official (AOR/SO), and must describe the need for additional funding and the categorical costs.
Administrative supplement requests should be sent as attachments in an email to: [email protected].
Applicants who prefer to submit hard copy (paper) requests should send them to:
NIDA Grants Management Branch
6001 Executive Boulevard
Room 4218, MSC 9560
Bethesda, MD 20892-9560, or for express delivery please use
Rockville, MD 20852
Requests should be submitted on the PHS398
Application Guide forms (font size and other formatting rules apply as
designated in the instructions), as indicated below. Include only the following
elements:
Cover Letter which cites this Notice, and the following information:
- Project Director/Principal Investigator (PD/PI) name
- Parent grant number and title
- Amount of the requested supplement
- Name and title of the institutional official, and
- Phone, email, and address information for both the PD/PI and institutional official.
- The cover letter must be signed by the authorized organizational representative/institutional official.
PHS 398 Form Page 1 (Face page)
- The title of the project should be the title of the parent award.
- This Notice should be cited in Box 2, and the yes box should be checked.
- The Principal Investigator (PI) must be the same as the PI on the parent award. For Multiple PI parent awards, the Contact PI must be the PI listed on the supplement request, and the supplement cannot change the Multiple PI team.
- The remaining items on the face page should be filled out in accordance with the PHS 398 application instructions.
PHS 398 Form Page 2
- Note: The project summary is that of the administrative supplement, not the parent grant.
A brief proposal describing the project, including:
-
Scope of the overall project and the anticipated contribution of
the requested supplement (not to exceed five pages).
- Provide a brief description of the scope of the overall project on which the supplemental request is based.
- This section should include a description of the supplement's specific aims, including research design and methods and data analysis. Describe the relationship of the supplement request to the parent grant.
- Budget for the supplement with a justification that details the items requested, including Facilities and Administrative costs. . The budget format should be the same as that of the Parent Grant. Any no cost extension should be in place before submitting an administrative supplement.
- Biographical Sketch for all new key personnel (those who are additions on the supplemental project
- Human Subjects/ Vertebrate Animal documentation (if applicable).
- Include a current Human Subjects/IRB or Vertebrate Animals/IACUC approval letter, if available. Otherwise, this will be required at the time of funding. All appropriate IRB and IACUC approvals must be in place prior to a supplement award being made.
- Any differences in the involvement or use of human subjects or specimens, or use of vertebrate animals, between the administrative supplement activity and the parent grant should be noted.
- When appropriate, details should be provided on the protection of human subjects and inclusion of women, children, and minorities. Additional guidance on Human Subjects Research and Vertebrate Animals is provided under Part II of the PHS 398 instructions.
- PHS 398 Checklist Form
Administrative supplement requests will be reviewed administratively by NIH Staff. Selection factors will include the following:
- Relevance of the proposed activities to the parent grant
- Adequate progress of the parent grant appropriate to the current stage of the project
- Appropriate and well-described plan to accomplish the goals within the timeframe proposed
- Expertise of the research team proposed to conduct and achieve the goals the supplemental study.
Inquiries and discussion of plans for responding to this Notice are strongly encouraged.
Sarah Q. Duffy, Ph.D., Associate Director for Economics Research
Division of Epidemiology, Services, and Prevention Research
National Institute on Drug Abuse
6001 Executive Boulevard Rm. 5195
Bethesda, MD, 20892
(301)451-4998
[email protected]
and Human Services (HHS)
