Behavioral and Integrative Treatment Development Program (R01 Clinical Trial Optional) | PA 18 055

Opportunity Information: Apply for PA 18 055

The Behavioral and Integrative Treatment Development Program (R01 Clinical Trial Optional), Funding Opportunity Number PA 18 055, is a National Institutes of Health (NIH) discretionary grant opportunity that supports research aimed at developing and rigorously testing behavioral and integrative interventions for drug abuse treatment and related health challenges. Using the R01 research project grant mechanism, the program is designed for investigators who are ready to move beyond early concept development and into more definitive studies that can demonstrate whether an intervention works, how it works, and under what conditions it works best. While clinical trials are permitted under this announcement, they are not required, giving applicants flexibility to propose either trial-based efficacy research or other intervention-development work that still advances treatment science.

The core goal of the FOA is to strengthen the evidence base for behavioral interventions and for approaches that combine behavioral and pharmacological strategies. It explicitly encourages research that tests efficacy, runs clinical trials where appropriate, and examines mechanisms of behavior change, meaning applicants are expected to look not only at outcomes but also at the processes that drive those outcomes. The FOA also highlights interest in dose-response questions (for example, how much of an intervention is enough to produce meaningful benefit), in optimizing combinations of components (such as pairing contingency management with medication-assisted treatment), and in determining the best sequencing of interventions (such as whether behavioral engagement strategies should precede medication initiation, or vice versa). This emphasis reflects a practical, implementation-aware mindset: the program is not just looking for interventions that are theoretically promising, but for interventions that can be structured, tuned, and delivered in real-world care settings.

The research scope is broad but clearly anchored in drug abuse treatment and adherence. First, the FOA supports behavioral, combined, sequential, or integrated behavioral plus pharmacological drug abuse treatment interventions, including interventions tailored for patients with comorbidities and designed for use across diverse settings. Second, it seeks drug abuse treatment and adherence interventions specifically suited to primary care, recognizing that substance use disorders are often identified and managed outside specialty addiction programs. Third, it encourages technology-enabled interventions that can boost effectiveness and make delivery more feasible and scalable, which can include digital tools, telehealth components, mobile supports, or other technology-based enhancements aimed at improving uptake and fidelity. Fourth, it includes interventions intended to prevent acquisition or transmission of HIV among individuals in drug abuse treatment, reflecting the intersection of substance use, risk behavior, and infectious disease. Fifth, it supports interventions that promote adherence not only to drug abuse treatment itself, but also to HIV medications and addiction medications, acknowledging that adherence is a major determinant of outcomes across these conditions. Sixth, it includes interventions to treat chronic pain, a domain closely tied to substance use risk and opioid-related harms, and one where behavioral and integrative models are often central to effective care.

In terms of study maturity, the FOA specifically notes interest in Stage II and Stage III efficacy research. In practice, that typically means projects that are ready for more rigorous testing than initial feasibility or pilot work, including controlled evaluations of efficacy, refinement of intervention components, testing mediators and moderators (the how and for whom questions), and efforts that move an intervention closer to readiness for broader dissemination. Applicants proposing clinical trials would generally be expected to justify design choices, articulate meaningful and measurable outcomes, and explain how the study will inform next-step decisions about intervention optimization, deployment, or integration with standard care.

Eligibility is intentionally expansive to encourage participation from a wide range of institutions and communities. Eligible applicants include many standard domestic categories such as state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofit organizations with or without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses. The FOA also calls out additional eligible applicant types, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-U.S. entities (foreign organizations). This breadth signals an interest in interventions that are culturally and contextually appropriate and that can be studied in the settings and systems where they will actually be used.

Administratively, the opportunity is listed under CFDA numbers 93.273 and 93.279, is categorized under Education and Health, and is administered by the NIH. The source information provided lists an original closing date of January 7, 2019, and a creation date of November 2, 2017; those dates indicate when the opportunity was originally posted and when applications were due in that cycle. Overall, this FOA is best understood as a vehicle for advancing well-developed behavioral and integrative treatment strategies for substance use disorders and closely linked conditions, with a strong emphasis on efficacy testing, understanding mechanisms, improving adherence, leveraging technology for impact and scalability, and addressing HIV risk and chronic pain within drug abuse treatment populations.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Behavioral and Integrative Treatment Development Program (R01 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.273, 93.279.
• This funding opportunity was created on 2017-11-02.
• Applicants must submit their applications by 2019-01-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for PA 18 055

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: