Simpler Grants.gov #RFA-MH-27-150

NIH RAPIDs-CTN network for real-world trials of rapid-acting psychotropic interventions

The National Institutes of Health is seeking applicants to build a clinical-trials network that evaluates rapid-acting psychotropic treatments in real-world care. - Government buyer: Department of Health and Human Services, National Institutes of Health (NIH); participating institutes are the National Institute of Mental Health (NIMH) and the National Institute on Drug Abuse (NIDA). - Requested work: Establish and operate the Rapid-Acting Psychotropic Interventional Drugs Clinical Trials Network (RAPIDs-CTN), including a Data Coordinating Center and federated clinical sites, and conduct pragmatic, multi-site trials. - Treatments in scope: Ketamine, esketamine, and emerging agents such as psilocybin and MDMA. No commercial OEMs or vendors are named, and no specific drug products or quantities are being purchased. - Key requirements: Develop unified protocols and generate evidence on effectiveness, safety, implementation, sustainability, workforce and care-delivery models, costs, monitoring, and retreatment. Use NIMH Common Data Elements, standardized and harmonized clinical data, and data-curation workflows that support deposition in the NIMH Data Archive. - Program structure and funding: A milestone-driven cooperative agreement with network establishment and pilot studies in Years 1–2, followed by full-scale pragmatic trials in Years 3–5. The opportunity anticipates three awards and identifies up to $12 million in program funding.

Description

This notice of funding opportunity seeks applications to establish a Rapid-Acting Psychotropic Interventional Drugs–Clinical Trials Network (RAPIDs-CTN). The network will generate real-world evidence to guide safe and effective implementation of RAPIDs in routine clinical practice through pragmatic clinical trials. The milestone-driven UM1 cooperative agreement has two stages: network establishment and pilot studies in Years 1–2, followed by full-scale trial execution in Years 3–5. The opportunity anticipates three awards and lists total program funding of $12,000,000.

View original listing