Prescription Drug Abuse (R01 Clinical Trial Optional) | PA 18 058

Opportunity Information: Apply for PA 18 058

The National Institutes of Health (NIH) funding opportunity titled "Prescription Drug Abuse (R01 Clinical Trial Optional)" (Funding Opportunity Number: PA-18-058) supports investigator-initiated research projects that advance understanding of prescription drug abuse and improve prevention, service delivery, and treatment responses. It uses the R01 grant mechanism, meaning it is intended for substantial, hypothesis-driven research programs that can be carried out over multiple years with clearly defined aims. The "clinical trial optional" label signals that applicants may propose studies that include clinical trials, but a clinical trial is not required; non-trial studies are equally appropriate if they address the FOA's goals.

The core purpose of the announcement is to stimulate innovative, rigorous research that explains why prescription drug abuse occurs, who is most affected, what harms result, and what interventions work best to prevent misuse and treat related disorders. NIH is looking for applications that dig into contributing factors at several levels, including individual and patient characteristics, prescriber behavior and decision-making, and broader health system influences such as access to care, prescribing policies, monitoring programs, and clinical workflows. The FOA also encourages research that clarifies the adverse consequences of prescription drug abuse, including medical outcomes (overdose, drug interactions, injury, progression to illicit opioid use), mental health outcomes (worsening depression or anxiety, development of substance use disorders, suicidality), and social consequences (family disruption, employment impacts, criminal justice involvement, educational disruption).

A notable emphasis is on covering the full landscape of prescription medications with high abuse potential, not only opioids. Applicants are encouraged to study analgesics (including opioid pain relievers), stimulants (often prescribed for ADHD and related conditions), sedative/hypnotics (frequently used for sleep), and anxiolytics (such as benzodiazepines for anxiety). The FOA is also interested in patterns involving multiple substances, including combinations of prescription drugs with each other or with other drug types, because polydrug use can dramatically increase risk and complicate prevention and treatment strategies.

Methodologically, the announcement is intentionally broad. It welcomes basic science approaches that illuminate mechanisms of misuse, dependence, and risk; clinical research that examines patient trajectories and intervention effects; epidemiological studies that measure prevalence, incidence, and changing trends; and health services research that evaluates how care is organized and delivered in real-world settings. Applicants are encouraged to define the scope of prescription drug abuse in ways that are specific and actionable, such as identifying which drug classes are driving harms, how patterns differ across geographic areas or health systems, and how the problem varies across populations.

The FOA places clear value on understanding variation across demographic and clinical groups. Applications are encouraged to analyze differences by age group, race and ethnicity, gender, and psychiatric symptomatology. This includes identifying populations at elevated risk, characterizing unique pathways into misuse (for example, initiation via legitimate prescribing versus diversion), and tailoring prevention and treatment approaches to the needs and contexts of those groups. In practice, NIH is signaling that strong proposals should not treat prescription drug abuse as a one-size-fits-all phenomenon, but rather as a set of related problems shaped by clinical indication, social environment, and individual vulnerability.

Another central theme is the relationship between the medication, the clinical reason it was prescribed, and the environmental and personal factors that influence whether use escalates into misuse or disorder. The FOA specifically points to indications such as pain, sleep disorders, anxiety disorders, and obesity, encouraging studies that connect prescribing for these conditions to downstream misuse risk. This can include research on how clinical management of symptoms interacts with mental health, stress, trauma exposure, peer and family influences, availability of diverted medications, and broader socioeconomic conditions.

In terms of interventions, NIH is interested in both prevention and treatment, spanning behavioral approaches (such as brief interventions, cognitive-behavioral strategies, contingency management, family-based approaches, and provider-focused training) and pharmacological treatments (including medications for substance use disorders and strategies to reduce misuse risk). Service delivery research is explicitly invited, which can include testing or evaluating care models that improve screening, referral, retention, and continuity of treatment, as well as models that integrate substance use care into primary care, pain clinics, emergency departments, and behavioral health settings.

Eligibility is expansive, reflecting NIH's intent to draw ideas from many sectors and institution types. Eligible applicants include state, county, city, and special district governments; independent school districts; public and private institutions of higher education; Native American tribal governments (federally recognized) and tribal organizations (including those not federally recognized); public housing authorities/Indian housing authorities; nonprofits (both with and without 501(c)(3) status); for-profit organizations (other than small businesses); and small businesses. The FOA also highlights additional eligible applicants such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), faith-based and community-based organizations, U.S. territories or possessions, regional organizations, and non-U.S. entities (foreign organizations). This broad eligibility aligns with the topic area, where community partnerships, health system participation, and diverse study settings are often essential.

Administratively, this is a discretionary grant opportunity under the NIH, tied to CFDA number 93.279, and categorized under education and health in the funding activity taxonomy. The original closing date listed in the source data is May 7, 2019, and the posting date information indicates the opportunity was created on November 2, 2017. The summary data provided does not specify an award ceiling or the expected number of awards, which typically means applicants need to consult NIH program and budget guidance for the R01 mechanism and align requested budgets with the scope and justification of the proposed work.

Taken together, PA-18-058 is designed to fund robust, multidisciplinary research that improves the evidence base on prescription drug abuse and translates that knowledge into better prevention, clinical practice, and treatment systems. Strong applications under this FOA would generally be expected to clearly define the prescription drug problem being targeted, specify the population and setting, use rigorous methods suited to the research questions, and show how the findings will inform practical responses to reduce misuse, harms, and disparities.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Prescription Drug Abuse (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): 93.279.
• This funding opportunity was created on 2017-11-02.
• Applicants must submit their applications by 2019-05-07. (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.

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