Target Assessment, Engagement and Data Replicability to Improve Substance Use Disorders Treatment Outcomes (R21/R33 Clinical Trial Optional)

Organization
NIH
Type
NIH
Number
PAR-18-086
Comments
LOI due 30 days prior to the application due date
Brief Description

This Funding Opportunity Announcement (FOA) is part of an NIH initiative known as Collaborative Research on Addiction at NIH (CRAN). Areas supported by this FOA include research to generate and conduct preliminary tests of targeted addiction treatment to address multiple substances, which may include alcohol, tobacco and other drug use (ATOD).

This FOA encourages applications that focus on early-stage, treatment generation and pilot clinical trials that are consistent with an experimental therapeutic approach. This approach requires the identification of a theory-derived target based on putative mechanisms of alcohol, tobacco and other drug use, and clear hypotheses about how a treatment directed at changing the target can lead to clinical benefits. 

Studies of novel treatments include, but are not limited to behavioral, pharmacological, physiological, learning- and device-based treatment approaches. This FOA provides support for up to two years (Phase I; R21) for protocol development, target identification and studies to confirm target engagement (i.e., link targets with tangible outcomes); followed by up to 3 years of support (Phase II; R33) for replication studies of addiction treatment across 2 or more settings. Specifically, this latter phase will focus on clinical trials that apply the target in a treatment setting (development, refinement, and/or adaptation) to evaluate the feasibility of conducting a larger trial.