Opportunity Information: Apply for PAR 14 225
Apply for PAR 14 225
- The National Institutes of Health in the education health sector is offering a public funding opportunity titled "Clinical Evaluation of Adjuncts to Opioid Therapies for the Treatment of Chronic Pain (R01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.213 Research and Training in Complementary and Integrative Health 93.279 Drug Abuse and Addiction Research Programs.
- This funding opportunity was created on May 15, 2014 and posted on May 15, 2014.
- Applicants must submit their applications by Sep 7, 2017. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: State governments County governments Independent school districts Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Public and State controlled institutions of higher education Private institutions of higher education Small businesses City or township governments For profit organizations other than small businesses Native American tribal organizations (other than Federally recognized tribal governments) Others (see text field entitled Additional Information on Eligibility for clarification) Public housing authorities/Indian housing authorities Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
The Clinical Evaluation of Adjuncts to Opioid Therapies for the Treatment of Chronic Pain (R01) funding opportunity (PAR-14-225) is a National Institutes of Health (NIH) research grant announcement focused on improving chronic pain management for patients who are already being treated with opioid analgesics. The central aim is to support clinical research that tests whether adding an adjunctive therapy alongside an opioid meaningfully improves pain relief outcomes in real-world chronic pain populations. The adjuncts of interest must be therapeutics that are either already approved by the U.S. Food and Drug Administration (FDA) or have enough prior clinical groundwork to have been studied under an Investigational New Drug (IND) application, which signals that the adjunct has an established evidence base and regulatory footing suitable for rigorous clinical evaluation. A key emphasis is that proposed studies should be oriented toward enhancing analgesia (improving pain control), rather than primarily trying to counteract or lessen opioid side effects.
A secondary purpose of the opportunity is practical and implementation-oriented: it seeks to increase awareness among opioid prescribers about the potential role and value of adjunctive therapies, using focused dissemination of study findings. In other words, the announcement is not only about generating clinical evidence, but also about making sure the resulting evidence is communicated in a way that can influence prescribing and pain management practice. This implies an interest in studies whose outcomes can be translated into clearer clinical decision-making, such as identifying which adjuncts add measurable benefit, in which patient subgroups, and under what treatment conditions.
Mechanistically, this is an R01 grant, meaning it is intended for substantial, hypothesis-driven, investigator-initiated research projects that can support robust clinical study designs. The activity area is health and education, and it aligns with NIH program areas associated with complementary and integrative health research and drug abuse/addiction research programs, as reflected by CFDA numbers 93.213 (Research and Training in Complementary and Integrative Health) and 93.279 (Drug Abuse and Addiction Research Programs). There is no cost sharing or matching requirement stated, which typically lowers barriers for applicants by not requiring institutional or third-party financial contribution as a condition of award.
The eligibility landscape is broad and includes many types of U.S.-based organizations and governments, such as state and local governments (including counties, cities or townships, and special district governments), public housing authorities/Indian housing authorities, independent school districts, and federally recognized tribal governments. It also includes nonprofits (both 501(c)(3) and non-501(c)(3), with the specified exceptions), public and state-controlled institutions of higher education, private institutions of higher education, small businesses, and for-profit organizations other than small businesses. The announcement further clarifies additional eligible applicants, including a wide range of minority-serving institutions and community-anchored organizations such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based and community-based organizations and eligible federal agencies.
Notably, the opportunity allows participation beyond U.S. borders. Non-U.S. entities (foreign organizations) and non-U.S. institutions are eligible to apply, and non-U.S. components of U.S. organizations are also eligible. Foreign components, as defined by the NIH Grants Policy Statement, are allowed as well. This opens the door for international clinical research teams or multinational collaborations to propose studies, as long as they fit NIH policy requirements and the scientific goals of evaluating adjuncts to opioid therapy for chronic pain.
From an administrative standpoint, the opportunity was posted and created on May 15, 2014, with an original and current closing date of September 7, 2017, and an archive date of October 8, 2017. The sponsoring agency is NIH, and the full announcement was available via the NIH grants guide at the listed link (http://grants.nih.gov/grants/guide/pa-files/PAR-14-225.html). For access issues or technical problems connecting to the funding announcement, the contact point provided is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
In practical terms, the program can be understood as targeting a clinically important question in pain medicine: when opioids are used for chronic pain, can carefully chosen, clinically grounded adjunct therapies improve pain relief enough to justify their addition, and can the evidence be packaged and communicated in a way that helps prescribers make better-informed choices. The announcement explicitly narrows the scope toward adjuncts intended to boost analgesic benefit, distinguishing it from efforts that primarily focus on managing opioid adverse effects, and it situates the research within a broader public health context where both pain treatment effectiveness and opioid-related risks are important considerations.
FAQs: Clinical Evaluation of Adjuncts to Opioid Therapies for the Treatment of Chronic Pain (R01) (PAR-14-225)
What is PAR-14-225 focused on?
PAR-14-225 is an NIH research grant announcement supporting clinical research on chronic pain patients who are already being treated with opioid analgesics. The goal is to test whether adding an adjunctive therapy alongside an opioid meaningfully improves pain relief outcomes in real-world chronic pain populations.
What is the main purpose of this funding opportunity?
The central aim is to generate clinical evidence on whether adjunctive therapies can improve analgesia (pain control) when used in addition to opioids for chronic pain, and to do so in a way that is relevant to real-world patients and prescribing decisions.
What is considered an "adjunct" therapy under this opportunity?
An adjunct is an additional therapeutic added to an opioid regimen to improve pain relief outcomes. The announcement emphasizes adjuncts that are therapeutics with regulatory and clinical grounding: either FDA-approved or supported by enough prior clinical work to have been studied under an Investigational New Drug (IND) application.
Do the adjunct therapies need to be FDA-approved?
Not necessarily. Adjuncts of interest must be either already approved by the U.S. Food and Drug Administration (FDA) or have sufficient prior clinical groundwork to have been studied under an IND application.
Why does the opportunity mention IND (Investigational New Drug) status?
IND mention signals that the adjunct has an established evidence base and regulatory footing suitable for rigorous clinical evaluation. In other words, the adjunct should not be purely exploratory without prior clinical or regulatory context.
Is the opportunity primarily about reducing opioid side effects?
No. A key emphasis is that proposed studies should be oriented toward enhancing analgesia (improving pain control), rather than primarily trying to counteract or lessen opioid side effects.
Is there an implementation or dissemination expectation?
Yes. A secondary purpose is to increase awareness among opioid prescribers about the potential role and value of adjunctive therapies by using focused dissemination of study findings. The announcement indicates interest in communicating results in ways that can influence practice.
What kinds of outcomes does NIH appear to want from these studies?
Based on the description, the opportunity is interested in outcomes that translate into clearer clinical decision-making, such as identifying which adjuncts add measurable benefit, in which patient subgroups, and under what treatment conditions, while keeping the emphasis on improved analgesia.
What grant mechanism is being used?
This is an R01 funding opportunity. An R01 is intended for substantial, hypothesis-driven, investigator-initiated research projects and can support robust clinical study designs.
What agency is sponsoring this funding opportunity?
The sponsoring agency is the National Institutes of Health (NIH).
What CFDA program areas are associated with this opportunity?
The announcement aligns with CFDA 93.213 (Research and Training in Complementary and Integrative Health) and CFDA 93.279 (Drug Abuse and Addiction Research Programs).
Is cost sharing or matching required?
No cost sharing or matching requirement is stated for this opportunity.
Who is eligible to apply?
Eligibility is broad and includes many types of U.S.-based organizations and governments, including state governments, local governments (counties, cities or townships), special district governments, public housing authorities/Indian housing authorities, independent school districts, federally recognized tribal governments, nonprofits (501(c)(3) and non-501(c)(3), with specified exceptions), public and state-controlled institutions of higher education, private institutions of higher education, small businesses, and for-profit organizations other than small businesses.
Are minority-serving and community-anchored institutions eligible?
Yes. The opportunity explicitly includes eligibility for a wide range of minority-serving institutions and community-anchored organizations, including HBCUs, Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, as well as faith-based and community-based organizations.
Are federal agencies eligible to apply?
Yes. The announcement indicates that eligible federal agencies may apply.
Are non-U.S. (foreign) organizations allowed to apply?
Yes. Non-U.S. entities (foreign organizations) and non-U.S. institutions are eligible to apply. Non-U.S. components of U.S. organizations are also eligible, and foreign components (as defined by the NIH Grants Policy Statement) are allowed.
Does this opportunity support multinational collaborations?
The eligibility language allows foreign organizations and foreign components, which makes multinational collaborations possible as long as they align with NIH policies and the scientific goals described (clinical evaluation of adjuncts to opioid therapy for chronic pain with an emphasis on improved analgesia).
When was the opportunity posted and when did it close?
The opportunity was posted/created on May 15, 2014. The original and current closing date was September 7, 2017. The archive date was October 8, 2017.
Where can applicants find the full announcement?
The full announcement was available in the NIH Grants Guide at: http://grants.nih.gov/grants/guide/pa-files/PAR-14-225.html
Who should be contacted for technical issues accessing the announcement?
For access issues or technical problems connecting to the funding announcement, the contact provided is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
What is the practical research question this program is trying to answer?
In practical terms, the program targets a clinical question in pain medicine: for chronic pain patients already treated with opioids, can carefully chosen adjunct therapies (with FDA approval or IND-level groundwork) improve pain relief enough to justify their addition, and can those findings be disseminated to inform prescriber decisions.
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