Substance Abuse: Minimally-Invasive Bioassays for Clinical Trials

R01 (also available: R21)

Clinical Development of Minimally-Invasive Bioassays to Support Outpatient Clinical Trials of Therapeutics for Substance Use Disorders

This Funding Opportunity Announcement (FOA) encourages Research Project Grant (R01) applications from institutions/organizations that propose to develop non-invasive methods to support outpatient clinical trials of pharmacotherapies for Substance Use Disorders (SUDs).

Clinical trials evaluating the efficacy of medications to treat SUDs are limited by two major issues:  a) uncertainty in assessing the level of a subject’s adherence to the trial medication regimen and b) an inability to accurately and quantitatively monitor the frequency and level of a subject’s illicit drug exposure. This FOA encourages the development of systems that address at least one of these issues. Applications submitted to this opportunity should focus around an outpatient clinical trial, with or without preclinical system development studies.  Applications not seeking to test a minimally invasive bioassay system in a clinical trial are not appropriate for this opportunity.


• Pre-Application Submission Deadline: N/A
• Application Submission Deadline: 5:00 PM local time of applicant organization, Feb. 5, 2017; Jun. 5, 2017; Oct. 5, 2017; Feb. 5, 2018; Jun. 5, 2018

Companion funding opportunity:


Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.