Notice of Availability of Administrative Supplements for Research on the Relationship between Treatment-Induced Reductions in Cocaine Use and Meaningful Clinical Outcomes


Notice Number:  NOT-DA-11-012

Key Dates

Release Date:  March 7, 2011
Receipt Date:   April 29, 2011
Earliest Anticipated Start Date:  July 1, 2011

Issued by

National Institute on Drug Abuse (NIDA)

Purpose

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.

Budget and Funding Information

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.

Eligibility

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: http://grants.nih.gov/grants/guide/pa-files/PAR-10-018.html.

Submitting an Administrative Supplement Request

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: NIDAGMBemail@mail.nih.gov. 

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:

PHS 398 Form Page 1 (Face page)

PHS 398 Form Page 2

A brief proposal describing the project, including:

Selection

Administrative supplement requests will be reviewed administratively by NIH Staff. Selection factors will include the following:

Inquiries

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
duffys@nida.nih.gov


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