The National Institutes of Health (NIH) has announced the K01 Mentored Research Scientist Development Award under the HEAL Initiative, focusing on Implementation Science for Substance Use Prevention and Treatment. The award is open to early-career researchers with foundational training in substance use prevention, treatment, or co-occurring mental illness and aims to support their advancement in implementation science through intensive, mentored career development. The HEAL (Helping to End Addiction Long-term) Initiative is designed to mitigate the opioid crisis by advancing research and scalable solutions in prevention, evidence-based treatment, harm reduction, and recovery support. This funding opportunity requires applicants to lead independent NIH-defined clinical trials or related studies, designed to advance evidence-based interventions and translate research findings into practice within clinical and community settings.

This K01 award provides up to 5 years of support, with NIH contributing a maximum of $90,000 annually toward the awardee’s salary and $50,000 annually for research-related expenses, including tuition, equipment, participant incentives, and travel. The budget may also be used to cover statistical and technical support. The awardee is expected to devote at least 75% of their full-time professional effort to the research and career development activities stipulated by the K01 award. Importantly, these awardees are also expected to attend the annual HEAL Investigators Meeting to facilitate networking, mentorship, and collaboration across projects within the initiative.

Eligible applicants include U.S.-based higher education institutions, certain nonprofits, small businesses, and various government entities. Candidates must have a full-time faculty appointment or equivalent at the time of the award, a doctoral degree in a relevant health-professional field, and demonstrate experience in substance use research. Foreign institutions and non-domestic components of U.S. organizations are not eligible to apply. Moreover, applicants must adhere to several registrations, including SAM, eRA Commons, and Grants.gov, and obtain a Unique Entity Identifier (UEI) to ensure eligibility for award processing. Eligible candidates are encouraged to consult with NIH program staff early in the application process to clarify requirements and alignment with HEAL Initiative goals.

The research focus for this FOA includes the integration of implementation science methods across prevention, treatment, harm reduction, and recovery domains. Projects may focus on testing strategies to increase the uptake and sustainability of evidence-based practices, de-implementation of ineffective practices, adaptation of interventions in diverse settings, and reducing health disparities among populations disproportionately affected by opioid use disorder. NIH particularly encourages proposals that address patient and stakeholder engagement, scalability, sustainability, and equity in service access and outcomes.

Applications are accepted on a rolling basis with deadlines every four months, including upcoming dates in February, June, and October each year through 2025. NIH’s dual-stage review process will assess applications based on the candidate’s potential, research significance, mentor expertise, and institutional support. Application evaluations will consider how effectively the research plan supports the applicant’s development into an independent investigator and the project’s alignment with HEAL Initiative objectives. Applications must include a Data Management and Sharing Plan to outline strategies for making data accessible and interoperable within the HEAL Data Ecosystem.

Mentors must be experienced in both substance use research and implementation science, with a proven track record in guiding mentees toward independent research careers. Institutional commitment to the candidate's development is also required, including assurances of access to resources, protected time, and an environment conducive to the applicant’s progression to research independence. Comprehensive mentor letters and institutional support statements are necessary, as are letters from collaborators where applicable. Additionally, applications must conform to all guidelines in the SF424 (R&R) Application Guide, including data sharing and human subjects research requirements, with strict adherence to NIH guidelines on Responsible Conduct of Research (RCR).

In summary, this K01 award supports research focused on applying implementation science to address the opioid crisis through structured career development. It offers extensive resources to promising researchers aiming to lead impactful clinical trials that bridge the gap between evidence-based research and practical implementation, with a focus on sustainability, scalability, and health equity in substance use prevention and treatment services.