Behavioral and Integrative Treatment Development Program (R01 Clinical Trial Optional)

The NIH’s National Institute on Drug Abuse (NIDA) invites applications for the “Behavioral & Integrative Treatment Development Program” (R01 Clinical Trial Optional) to support the development and testing of behavioral and integrative treatments for drug and alcohol misuse, dependence, and associated risk behaviors. This opportunity emphasizes the refinement and testing of behavioral interventions (psychotherapy, cognitive therapy, relapse prevention, skills training, etc.) at various stages of development: from early creation and adaptation to efficacy trials in research and community settings. Integrative approaches that combine behavioral treatments with pharmacotherapies or complementary therapies are encouraged, as are approaches targeting specific mechanisms of behavior change. The program will support research in Stages I-III as defined by the NIH Stage Model, from pilot testing to real-world efficacy trials. The focus of this program is on developing behavioral interventions that improve treatment efficacy, adherence, and retention in individuals with substance use disorders (SUDs). Projects are expected to address specific intervention components, mechanisms of change, or ways to boost treatment effects for diverse populations, including underserved or vulnerable groups. Examples of relevant interventions include motivational enhancement therapy, adherence interventions, HIV prevention interventions, and treatments to enhance medication efficacy for SUDs (e.g., methadone, buprenorphine). Research incorporating new technologies, like digital therapeutics, mobile applications, biofeedback, or imaging, is also encouraged, particularly to optimize behavioral interventions or understand their underlying mechanisms. Key dates include an open submission date starting on January 5, 2025, and the first application deadline on February 5, 2025. Letters of intent are requested 30 days before submission to help estimate the review workload. Applicants are strongly advised to follow the updated NIH application guidelines and forms (FORMS-I), available at least 30 days prior to the application deadline. Applications are accepted for new, renewal, resubmission, or revision of projects, with budgets determined by project needs. The maximum project period is five years. Eligible applicants include U.S. and foreign institutions of higher education, nonprofits, for-profit organizations, government entities, and certain tribal and community organizations. Foreign entities are also eligible to apply, either directly or as a component of a U.S. organization’s application. Registration with SAM, Grants.gov, eRA Commons, and other necessary platforms is mandatory for applicants. All investigators, including Program Directors/Principal Investigators (PD/PIs), must have active eRA Commons accounts. Applications requesting $500,000 or more in direct costs in any year must contact NIDA staff at least six weeks before submission to discuss funding policies. Evaluation of applications will consider three main criteria: the significance of the research, rigor and feasibility, and investigator expertise and resources. The proposed projects should demonstrate innovation, scientific rigor, and feasibility of conducting studies within proposed timeframes. The rigor of experimental design, sufficient sample size, and appropriate methods for analysis and interpretation will be scrutinized. Inclusion of diverse populations and plans for addressing variables such as age, sex, or race/ethnicity in study design are also critical. Awards will be granted based on scientific merit, alignment with program priorities, and fund availability. Awardees must comply with NIH policies on data management, safety monitoring for clinical trials, and any specific NIDA guidelines. Reports on progress, data sharing, and closeout are required annually and at project completion. For clinical trials, compliance with ClinicalTrials.gov registration and reporting is expected. This funding program is an essential part of NIDA’s commitment to enhancing behavioral treatments for substance misuse and related risk behaviors through evidence-based, innovative interventions.