Notice of Availability of Administrative Supplements for the Study of Remote Physiological Monitoring of Cocaine Use


Notice Number: NOT-DA-11-011

Key Dates

Release Date:  February 25, 2011
Receipt Date:  May 13, 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 supported research projects for research for the Study of Remote Physiological Monitoring of Cocaine Use.

Introduction

Cocaine use can be clinically manifested with signs and symptoms that vary depending on the purity of the used drug, route of administration, amount and frequency of use as well as individual differences such as plasma cholinesterase levels and tolerance level, and the concomitant use of other drugs. The signs and symptoms of cocaine use develop soon after its ingestion and are characterized by intense cardiovascular excitation (e.g, tachycardia, hypertension, and arrhythmias), vasoconstriction, increased psychomotor activity, hyperreflexia, fasciculations (particularly in the face and extremities), mydriasis, diaphoresis, hyperthermia, and tachypnea.

A critical limitation in the development of treatments for cocaine use disorders is the lack of real-time and objective measures of cocaine use. Technological advances are allowing the real-time evaluation of physiological changes, often sparing the patient from visiting a doctor’s office or a clinical laboratory to perform a test and obtain the result. Remote physiological monitoring (RPM) is a form of telemedicine that is rapidly developing. It uses technology to track patients’ health status without face-to-face contact. Health parameters, such as heart rate, heart rhythm, blood pressure, oxygen saturation, skin temperature, and glucose levels, among others, can be measured using devices that can store and or transmit the results in real-time. Given the multiple and measurable clinical manifestations of cocaine use, an RPM device to evaluate the clinical manifestations of cocaine use is not only feasible but also can offer multiple clinical and research applications.

Purpose

The purpose of this supplement is to provide funds to qualified investigators to evaluate existing remote monitoring tools to measure in real-time the physiological and clinical manifestations of cocaine use. The goal of this supplement request is to identify and test RPM tool(s) that can potentially provide valid and reliable data about the amount and frequency of cocaine use among cocaine users in their natural settings. It is expected that such device could be used to monitor cocaine use in clinical trials of therapeutic interventions for cocaine dependence and eventually be used by clinicians to monitor cocaine use in patients receiving treatment.

Budget and Funding Information

Supplement requests may not exceed $95,000 (direct costs).

Eligibility

The supplement request is for one year of funding. Applicants must hold an active grant funded by NIDA, under the following mechanisms: R01, U01, U10, U19, P01, P20, P50 and P60; with a current project period end date of October 1st, 2012 or later.  The duration of the award may not exceed the end date of the active parent grant and the proposed research must be within the scope of the parent grant. Any no cost extension should be in place before submission.   Before submitting a supplement application, potential applicants are highly encouraged to contact the program official of the parent grant to discuss the supplement plan and determine the responsiveness and pertinence of the potential application.

To be eligible, the parent grant must be active, 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.

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:

Budget for the supplement with a justification that details the items requested, including Facilities and Administrative costs. Should be in the same budget format as the Parent Grant.

Supplement applications can be submitted at any time, but not later than 5 PM EST of May 13, 2011.

Selection

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

Review Considerations

Applications will be reviewed administratively. The review criteria include the feasibility of using the RPM tool, its clinical pertinence, expertise of the key personnel involved, availability of resources to conduct the study, quality of the research methods, the relevance of the supplement to the aims of the parent grant, and the quality of the progress of the parent grant.

Inquiries

Inquiries and discussion of plans for responding to this Notice are strongly encouraged.

Ivan D. Montoya, M.D., M.P.H.
National Institute on Drug Abuse
6001 Executive Blvd. Room 4131
Bethesda, MD 20892
Telephone:  301-443-8639
Email:  imontoya@nida.nih.gov


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