Notice of Availability of Funds for Competitive Revision Applications for Research to Determine if Reduction in Illicit Drug Use is Associated with Improvement in Clinical Outcome(s)

Notice Number:

NOT-DA-14-049

Key Dates

Release Date:   October 16, 2014

Related Announcements

None

Issued by

National Institute on Drug Abuse (NIDA)

Purpose

The National Institute on Drug Abuse (NIDA) announces the opportunity for investigators and United States institutions/organizations with relevant active NIH-supported research project grants (R01, R03, R15, R21, R21/33, and R37), research centers (P- grants) and cooperative agreements (U- grants) to submit competitive revision applications aimed at determining patterns of drug use that are valid surrogates for clinical benefit. The goal is to show that reductions in frequency/level of illicit drug use is associated with improved functional (e.g., health, social, economic), psychosocial and/or other health-related outcomes (e.g., morbidity, mortality), or any other additional outcome(s) of clinical importance by interrogating data already collected from cohorts. The cohort data should include drug use and clinical outcome information collected at least on a weekly basis and for at least 2 months. 

This Notice will support analysis of existing data sets to determine if some level of reduction in illicit drug use is associated with detectable candidate outcome(s) improvements. In scope data sets should include those where data is collected by self-report of illicit drug use with or without confirmatory qualitative or quantitative analysis of body fluids (e.g., urine, hair, blood). Candidate outcomes may include morbidity and mortality and any other survival-related indices, health services utilization, social (e.g., involvement in the criminal justice system), psychosocial, and/or economic (e.g., employment) indicators as well as a broad range of health status and quality of life determinants.

Revision applications can support a significant expansion of the scope or research protocol approved and funded for the “parent” award on which the revision application is based. Prospective investigators are encouraged to consult the Program Officials listed on this announcement to ensure that the projects will considerably contribute to achieving the goal of this Notice.

Revision applications must be sent in response to an FOA with the same activity as the parent grant (i.e., if a grantee seeks a competitive supplement to an R01, the revision application must be sent in response to an FOA for R01s) and that allows revision applications. The FOA does not need to be the one to which the parent grant was submitted.

Revision applications must be seeking supplemental funding for a grant that will have at least as much time remaining on it as the amount of time being sought by the supplement.

The ultimate goal of this Notice is to provide evidence that will enable regulatory authorities to accept reductions in illicit drug use as a valid outcome measure in clinical trials of pharmacotherapies for the treatment of substance use disorders.

Inquiries

Please direct all inquiries to:

Ivan Montoya, MD
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-8639
Email: imontoya@mail.nih.gov