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

Organization
NIH
Type
NIH
Number
PAR-18-085
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).

The purpose of this FOA is to provide support for applications that focus on data replication and the scalability of novel, targeted addiction treatments. Consistent with an experimental therapeutics approach, studies that would fall under the R33 (Phase II) would include studies with theory-derived targets (based on putative mechanisms of ATOD) and clearly defined hypotheses about how the proposed treatment directed at changing the target relates to clinical outcomes. In addition, studies that include preliminary efficacy with respect to target engagement and validation (i.e., data to establish the relation between target and symptom reduction and functional outcomes) are essential to the Phase II arm (R33). Studies of novel treatments include, but are not limited to behavioral, pharmacological, biologics-based, cognitive, device-based, interpersonal, physiological, or combined approaches. This FOA provides support for replication studies of addiction treatment across 2 or more settings. Specifically, this phase will focus on clinical trials that apply the target in a treatment setting (testing, refinement, and/or adaptation) to evaluate the efficacy and replicability of larger trials. Ultimately, the goal of this FOA is to replicate findings of mechanisms and processes underlying treatments or replication of strategies into novel intervention approaches that can be efficiently tested and replicated for their promise to address substance use disorder outcomes. Furthermore, these studies build on data that have been demonstrated with sufficient signal of target engagement from an analogous R21-like study to justify the proposed R33 trials.