HEAL Initiative: HEALthy Brain and Child Development (HBCD) Study (Collaborative U01- Clinical Trial Not Allowed)

The National Institute on Drug Abuse (NIDA), a component of the National Institutes of Health (NIH), is forecasting a Notice of Funding Opportunity (NOFO) under the NIH HEAL (Helping to End Addiction Long-term) Initiative for the continuation of the HEALthy Brain and Child Development (HBCD) Study. This NOFO will be released to support a large-scale collaborative research project utilizing the U01 cooperative agreement mechanism. The aim is to enable ongoing participant recruitment, retention, behavioral and biospecimen data collection, and neuroimaging for the HBCD study. The forecast is intended to provide applicants with time to prepare competitive and responsive applications, but applications are not yet being accepted. The HBCD study is designed as a longitudinal cohort study involving approximately 7,200 dyads of pregnant women and their children, beginning from the second trimester of pregnancy and continuing through childhood. A major focus of this research is to investigate the effects of pre- and perinatal exposure to substances such as prescription and illicit opioids, marijuana, stimulants, alcohol, and nicotine on child brain and behavioral development. The project seeks to produce a comprehensive understanding of both short-term and long-term developmental trajectories influenced by such exposures. Funding will support institutions in implementing essential research activities including recruitment, participant retention, behavioral assessments, biospecimen collection, and neuroimaging. The outcomes of this work are anticipated to inform strategies and interventions that promote health and resilience in children, particularly those exposed to adverse conditions before or shortly after birth. Eligible applicants for this opportunity include a wide array of institutional types such as state and county governments, both public and private institutions of higher education, Federally recognized Native American tribal governments, and nonprofit organizations with 501(c)(3) IRS status. Specific application guidelines and instructions will be made available when the official NOFO is released, but this early notice is intended to foster collaboration and advanced project planning. The forecasted dates include an estimated NOFO release on July 18, 2025, with applications due by October 17, 2025. Awards are expected to be made by July 1, 2026, which is also the expected start date for funded projects. The initiative anticipates issuing up to 27 awards but does not specify a total funding amount or range for individual awards at this stage. For further information, potential applicants are encouraged to contact Dr. Janani Prabhakar via email at janani.prabhakar@nih.gov or by phone at 301-827-4729.