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

Notice Number: NOT-DA-11-011

Release Date: February 25, 2011
Receipt Date: May 13, 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 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.

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

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.

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:

• 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. 
• A 3-page proposal describing in detail the RPM device, the physiological parameters that can measure, and the scientific methods to evaluate its value to accurately assess cocaine use in real-time. It should also describe the ability of the research team and availability of resources to conduct the study, as well as the relevance of the supplemental plan to the specific aims of the parent grant.

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.

• 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

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

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.

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 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