Behavioral Therapies Development Program

Limited Competition: Growing Great Ideas: Research Education Course in Entrepreneurship and Product Development for Researchers Studying Drug Use, Drug Misuse, and Drug Addiction (UE5 Clinical Trial Not Allowed) is sponsored by National Institute on Drug Abuse (NIDA). This program aims to support the development of educational courses that provide researchers with the skills necessary to translate their research on drug use and addiction into practical applications.

This Notice of Funding Opportunity (NOFO) invites applications from clinical centers to participate in a consortium to test anti-obesity medication (AOM) treatment strategies for youth with obesity that maximize benefits and minimize risks of AOM use. Such intervention strategies should support the promotion of healthy growth and development; adequate nutritional status/intake, healthy eating and physical activity behaviors; mental health and well-being (e.g., body image, self-esteem, mood, etc.), and quality of life and be feasible to implement in clinical care settings. Priority areas include testing strategies to determine optimal developmental stage for AOM initiation, rate and amount of weight loss, AOM class, dose, frequency, and duration, and content and intensity of adjunct lifestyle therapies that may be imperative to ensure normal psychological and physical development and to potentially avoid lifelong dependence on AOMs. Investigators should also evaluate potential predictors of response/ nonresponse to various treatment strategies under evaluation. The clinical centers may conduct independent or multicenter trials but will collaborate on the development of protocols, use of common measures and data elements, use of a central laboratory and standardized procedures to collect data and biospecimens, and data analyses and manuscripts. This NOFO uses a cooperative agreement mechanism (U01) and runs in parallel with a companion NOFO (RFA-DK-27-136). Funding Opportunity Number: RFA-DK-27-121. Assistance Listing: 93.847. Funding Instrument: CA. Category: HL. Award Amount: Up to $1M per award.

This Notice of Funding Opportunity (NOFO) invites applications for a Research Coordinating Center (RCC) to participate in a consortium of clinical centers that will test anti-obesity medication (AOM) treatment strategies for youth with obesity that maximize benefits and minimize risks of AOM use. Such intervention strategies should support the promotion of healthy growth and development; adequate nutritional status/intake, healthy eating and physical activity behaviors; mental health and well-being (e.g., body image, self-esteem, mood, etc.), and quality of life and be feasible to implement in clinical care settings. Priority areas include testing strategies to determine optimal developmental stage for AOM initiation, rate and amount of weight loss, AOM class, dose, frequency, and duration, and content and intensity of adjunct lifestyle therapies that may be imperative to ensure normal psychological and physical development and to potentially avoid lifelong dependence on AOMs. Investigators should also evaluate potential predictors of response/ nonresponse to various treatment strategies under evaluation. The clinical centers may conduct independent or multicenter trials but will collaborate on the development of protocols, use of common measures and data elements, use of a central laboratory and standardized procedures to collect data and biospecimens, and data analyses and manuscriptsThe RCC will lead, manage, and harmonize efforts for the Consortium including 1) providing management and administrative support; 2) providing leadership and expertise on statistical design and analysis, 3) providing research coordination with a central laboratory, 4) harmonizing data collection methods and use of common data elements, 5) developing the database; 6) conducting data management and data analyses for Consortium studies; and 7) fostering research collaborations. This NOFO uses a cooperative agreement mechanism (U24) and runs in parallel with a companion NOFO (RFA-DK-27-121). Funding Opportunity Number: RFA-DK-27-136. Assistance Listing: 93.847. Funding Instrument: CA. Category: HL. Award Amount: $1M total program funding.

Summary: The fiscal year 2026 (FY26) Traumatic Brain Injury and Psychological Health Research Program (TBIPHRP) Clinical Trial Award (CTA) intends to support clinical trials with the potential to have a significant impact on psychological health conditions and/or traumatic brain injury (TBI) through clinical applications, including health care products, technologies and/or practice guidelines. Distinctive Features: Funding from this award mechanism must support a clinical trial.· Clinical trials may be designed to evaluate a wide range of interventions, including new drugs, biologics, medical devices, diagnostics, therapies and behavioral health strategies.· Preliminary data are required.· The inclusion of community-based participatory research (CBPR) approaches is required.· The CTA offers funding for two Research Levels. The applicant is responsible for selecting the Research Level based on the scope of the research.○ Research Level 1: Supports proof-of-principle pilot studies, as well as phase 1 and phase 2 clinical trials.○ Research Level 2: Supports larger-scale and advanced clinical trials that evaluate effectiveness in relevant patient populations.· Early-Career Investigator Partnering Option (available for both Research Levels): This option accommodates two Principal Investigators (PIs), one of which is an Early-Career Investigator. If recommended for funding, each PI will receive a separate award. Funding Opportunity Number: HT942526TBIPHRPCTA. Assistance Listing: 12.420. Funding Instrument: G. Category: ST. Award Amount: $18.6M total program funding.