Grand Opportunity in Medications Development for Substance-Use Disorders (U01 – Clinical Trial Optional)
NIH - National Institutes of Health (PAR-19-327)
- Amount: Up to $5M per year
- Duration: Up to 3 years
The purpose of this FOA is to accelerate the development of medications for the treatment of Substance Use Disorders (SUDs) by encouraging research applications to support a diverse array of preclinical and/or clinical research projects. The goal is to fund medication studies that will have high impact and yield the necessary results to advance medications closer to FDA approval. It is expected that these U01s will be short-term (funded for up to 3 years) and large (up to $5 million per year) grants, with close monitoring and significant scientific involvement of NIDA staff. These U01s will enable studies that would not be feasible using the traditional R01 activity code.
Applications should focus on the development of compounds for the treatment of SUDs including opioids, methamphetamine, cocaine, nicotine, cannabis or any other illicit substance. It can include the evaluation of:
- new chemical entities (NCEs),
- already-marketed medications,
- biologics (i.e., vaccines, antibodies, enzymes, gene therapies, etc.),
- combinations of medications, and/or
- new delivery devices/technologies
The medications investigated for SUDs may target one or more of the neuropathological mechanisms, the various clinical stages, and/or the medical/psychiatric complications of one or multiple SUDs.
It is expected that all applications involving individuals seeking treatment will provide a behavioral therapy. However, the scope of this FOA does not include the evaluation of the safety and/or efficacy of psychosocial interventions.
Ivan D. Montoya, M.D., M.P.H.
National Institute on Drug Abuse (NIDA)