Adolescent Overdose Prevention and SUD Treatment Initiative (R21 - Clinical Trial Not Allowed) | RFA DA 25 030

Frequently Asked Questions (FAQs)

What is the Adolescent Overdose Prevention and SUD Treatment Initiative (R21 - Clinical Trial Not Allowed)?

It is an NIH discretionary grant opportunity (Funding Opportunity Number RFA-DA-25-030) that supports early-stage, exploratory, and developmental research focused on adolescent illicit fentanyl use and overdose. The intent, consistent with the R21 mechanism, is to fund projects that build foundational evidence, test promising ideas, or establish feasibility rather than conduct large, definitive studies.

What is the main goal of this funding opportunity?

The main goal is to create a clearer and more actionable picture of how and why overdoses are occurring among adolescents at elevated risk, and to use that understanding to identify practical targets for overdose prevention as well as substance use disorder (SUD) treatment and recovery strategies.

Which agency is sponsoring this opportunity?

The sponsoring agency is the National Institutes of Health (NIH).

What is the funding instrument and activity category?

The instrument is a grant. The activity category is listed under education and health.

What does the R21 mechanism imply for the type of project being funded?

The R21 mechanism generally supports exploratory or developmental work. For this opportunity, that means projects are expected to generate near-term evidence, pilot or feasibility findings, methods advances, or early insights that can inform later research and more mature prevention or treatment strategies.

Are clinical trials allowed under this FOA?

No. This opportunity is designated "Clinical Trial Not Allowed," meaning applicants should not propose studies that meet NIH definitions of a clinical trial, such as prospectively assigning participants to an intervention to evaluate health-related outcomes.

If clinical trials are not allowed, what kinds of study designs fit this opportunity?

The announcement emphasizes non-trial designs such as observational research, analyses of existing datasets (medical, public health, education, or other surveillance-type data), survey-based research, social network analysis, methods development to improve measurement or detection of fentanyl exposure and overdose risk, and feasibility or pilot research that supports later larger studies.

Is the initiative focused only on intentional fentanyl use?

No. The initiative is interested in understanding patterns of fentanyl involvement in adolescent drug use and overdose, including both intentional fentanyl use and unintentional exposure through fentanyl-laced drugs.

What specific topics or research questions are encouraged?

The FOA encourages research that clarifies patterns of fentanyl involvement in adolescent drug use and overdose, identifies how and why overdoses occur among higher-risk youth, and pinpoints practical leverage points for overdose prevention and for SUD treatment and recovery strategies.

What data sources or methods does NIH encourage applicants to use?

The FOA explicitly encourages a range of approaches, including secondary analyses of existing data sources (such as medical, public health, education, or surveillance datasets), surveys to capture attitudes and behaviors, social network analysis to map peer influences and risk transmission, methods development to improve measurement or detection of fentanyl exposure and overdose risk, and feasibility/pilot work.

What outcomes or constructs does the FOA highlight as important to measure or explain?

The FOA highlights outcomes and constructs that inform prevention and treatment, including: prevalence of overdose and patterns of overdose among adolescents; changes or reductions in substance use (especially fentanyl use and drugs frequently contaminated with fentanyl); differences by risk group; stigma and its effects on disclosure, help-seeking, and access to care; family and environmental risk and protective factors; and treatment engagement factors such as barriers to initiation, retention, and recovery supports.

Does the FOA care about differences among subgroups of adolescents?

Yes. It calls attention to differences by risk group, which may include demographic, behavioral, or contextual categories that help identify which adolescents are most vulnerable and why.

How does stigma fit into the scope of this opportunity?

The FOA explicitly values research on stigma and how it affects disclosure, help-seeking, and access to care, recognizing that stigma can directly shape whether adolescents seek support and whether they can effectively engage with services.

Are family and environmental factors within scope?

Yes. The announcement highlights interest in family and environmental risk and protective factors that can increase overdose danger or buffer against it.

What aspects of treatment and recovery are included?

The FOA highlights treatment engagement, including barriers to starting care, factors influencing retention, and recovery supports. The emphasis is on research that can improve understanding of how adolescents enter, remain in, and are supported through SUD treatment and recovery pathways.

What is "optimistic bias" and why is it mentioned?

"Optimistic bias" refers to the tendency for individuals to underestimate their personal risk compared to others. The FOA notes interest in youth perceptions of substance use and optimistic bias because these perceptions can shape risk-taking behavior and the effectiveness of prevention messaging.

Who is eligible to apply for this grant?

Eligibility is broad. Eligible applicants include various government entities (state, county, city, township, special district), independent school districts, public and private institutions of higher education, federally recognized Native American tribal governments, public housing authorities and Indian housing authorities, Native American tribal organizations (other than federally recognized tribal governments), nonprofits with or without 501(c)(3) status (with exclusions noted for institutions of higher education in those nonprofit categories), for-profit organizations other than small businesses, small businesses, and other entities.

Are specific institution types (like HBCUs or Hispanic-serving institutions) mentioned as eligible?

Yes. The FOA highlights additional eligible categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), and other similar institution types.

Can faith-based or community-based organizations apply?

Yes. Faith-based and community-based organizations are listed among eligible applicant categories.

Are U.S. territories or possessions eligible?

Yes. U.S. territories or possessions are included among eligible applicant categories.

Are foreign (non-U.S.) organizations eligible to apply?

Yes. Non-U.S. entities (foreign organizations) are included as eligible applicants, which may support comparative research, methods development, or multinational collaborations where appropriate and allowable under NIH policy.

What are the CFDA numbers associated with this opportunity?

The CFDA numbers listed are 93.273 and 93.279.

What are the key dates provided in the listing?

The opportunity was created on 2023-11-17, and the original closing date shown is 2024-03-13.

Does the listing specify an award ceiling or expected number of awards?

No. The posted information does not specify an award ceiling or expected number of awards in the fields provided. Applicants would typically need to consult the full FOA and NIH policy references for budget expectations, typical R21 project period norms, and any announcement-specific constraints.

What does this FOA prioritize overall?

It prioritizes generating high-value, near-term evidence that can sharpen overdose prevention and SUD treatment efforts for adolescents in the context of fentanyl risk. It emphasizes clarifying who is most at risk, how social and environmental factors shape risk, how youth perceive and misjudge fentanyl-related danger, and what practical leverage points could improve prevention, engagement with care, and recovery pathways, without proposing a clinical trial.