Long Acting, Sustainable Therapies for Opiate Addiction (R01) | Apply Online

Frequently Asked Questions (FAQs)

What is the Long Acting, Sustainable Therapies for Opiate Addiction (R01) opportunity?

This is a National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH) funding announcement focused on improving treatments for opiate addiction in ways that also reduce HIV acquisition and transmission risk. The program emphasizes longer-lasting, more sustainable interventions that can stabilize patients, reduce relapse, and reduce HIV-related risk behaviors.

What is the Funding Opportunity Number (FON) for this announcement?

The Funding Opportunity Number is PAS-08-061.

What funding mechanism is used?

Funding is provided through the NIH Research Project Grant (R01) mechanism, which typically supports discrete, hypothesis-driven research projects. Under this announcement, projects may range from preclinical development to clinical testing, depending on what is scientifically appropriate for the proposed aims.

Which NIH institute is sponsoring this opportunity?

The opportunity is sponsored by the National Institute on Drug Abuse (NIDA), which is part of the National Institutes of Health (NIH).

What is the main purpose of this FOA beyond treating opioid use disorder?

A central expectation is that projects connect addiction treatment outcomes to public health outcomes, specifically reductions in HIV risk. Applications are expected to address HIV risk reduction as an integral part of the research rather than focusing on addiction endpoints alone.

How does the FOA link opioid treatment to HIV prevention?

The FOA is based on the idea that better, longer-lasting treatments can reduce relapse and stabilize patients, which may lower behaviors associated with HIV risk, such as injection drug use, needle-sharing, and unsafe sexual practices. Proposed studies are expected to measure HIV risk behaviors as outcomes.

What are the three main research directions highlighted in the FOA?

The announcement highlights: (1) development of heroin/morphine protein conjugates (heroin/morphine conjugate vaccines), (2) research on clinical systems for applying already-available long-acting opioid pharmacotherapies (sustained-release formulations lasting 30 days or longer), and (3) development and testing of effective clinical treatment modalities, including behavioral interventions used alongside pharmacotherapies, to improve treatment effectiveness and reduce HIV-related risk behaviors.

What are heroin/morphine conjugate vaccines (HCVs) in the context of this FOA?

HCVs are immunotherapy-style approaches designed to generate antibodies that bind heroin, morphine, or related metabolites in the bloodstream. The intended effect is to prevent or blunt psychoactive effects, potentially reducing reinforcement and relapse.

Does the FOA support research on long-acting opioid medications?

Yes. It encourages research on clinical systems for applying already-available long-acting opioid pharmacotherapies, defined as sustained-release dosage forms lasting 30 days or longer. The focus is not only on the medication, but also on practical, clinic-ready systems to deploy these formulations effectively and improve adherence and real-world impact.

What does the FOA mean by “clinical systems” for long-acting pharmacotherapies?

The emphasis is on developing and studying practical systems that help clinics implement long-acting treatments effectively (for example, systems that improve adherence, support consistent delivery of monthly-or-longer coverage, and optimize outcomes). The FOA frames this as an implementation challenge as much as a pharmacotherapy question.

Are behavioral interventions within scope?

Yes. The FOA calls for development and testing of effective clinical treatment modalities, including behavioral interventions used alongside pharmacotherapies, to improve overall treatment effectiveness and reduce HIV-related risk behaviors.

For clinical studies, are HIV risk behaviors required outcomes?

Yes. The FOA makes clear that HIV risk behaviors should be measured as outcomes in clinical studies. Applicants are expected to build HIV risk assessment into their study design rather than treating it as secondary or incidental.

What kinds of HIV risk outcomes does the FOA suggest measuring?

Examples mentioned or implied include measurable changes in injection frequency, needle-sharing, engagement in harm-reduction services, sexual risk behaviors, and other validated indicators that can be linked to HIV acquisition and transmission risk.

How should applicants demonstrate the connection between the intervention and HIV risk reduction?

Applications are expected to present a credible pathway showing how sustained or durable addiction treatment (for example, monthly or longer medication coverage or vaccine-based blockade approaches) could lead to measurable reductions in HIV risk behaviors and related circumstances.

What is the CFDA number for this opportunity?

The opportunity is tied to CFDA 93.279, Drug Abuse and Addiction Research Programs.

What activity areas does this discretionary grant fall under?

The opportunity is described as a discretionary grant within the Health and Education activity areas.

How much funding did NIDA intend to commit, and how many awards were anticipated?

NIDA indicated an initial intent to commit approximately $4,000,000 in fiscal year 2008 to support about 6 to 8 meritorious awards.

Was continued funding in future years guaranteed?

No. Continued funding was not set aside in advance and would depend on the availability of appropriations and the quality and volume of applications received.

When was the FOA posted, and what were the close and archive dates?

The posting date was December 21, 2007. The closing date was January 7, 2011. The archive date was February 7, 2011.

Is this FOA still open for applications?

No. The announcement is archived, with a closing date of January 7, 2011 and an archive date of February 7, 2011.

Why might the archived FOA still be useful?

Even though it is archived, the summary can serve as a reference for the types of opioid treatment and HIV risk reduction research NIH has sought to stimulate, particularly around long-acting formulations, implementation systems, and combined pharmacotherapy-plus-behavioral models.

Who is eligible to apply?

Eligibility is broad and includes state and local governments; public and private institutions of higher education; nonprofit organizations (with or without 501(c)(3) status); for-profit organizations (including small businesses and other for-profit entities); independent school districts; public housing authorities (including Indian housing authorities); special district governments; tribal organizations and governments (including federally recognized tribal governments); foreign institutions; eligible federal government agencies; and faith-based and community-based organizations.

Are foreign institutions eligible under this FOA?

Yes. The FOA explicitly notes that foreign institutions may apply.

Are for-profit organizations eligible?

Yes. For-profit organizations are eligible, including small businesses and other for-profit entities.

Are faith-based and community-based organizations eligible?

Yes. The FOA states that faith-based and community-based organizations are eligible.

Are tribal governments and tribal organizations eligible?

Yes. Tribal organizations and governments, including federally recognized tribal governments, are included in the eligible applicant types.

Is cost sharing or matching required?

No. The FOA indicates that no cost sharing or matching is required.

What would a competitive application be expected to demonstrate?

Based on the FOA description, a competitive application would be expected to go beyond showing reduced opioid use. It would also need to demonstrate a credible, measurable pathway to reducing HIV risk, supported by endpoints that assess HIV-related risk behaviors and connect those changes to the sustained nature of the proposed intervention.

What is the overarching goal of the FOA?

The overarching goal is to produce durable, scalable treatment strategies that both treat opiate addiction and reduce the behaviors and circumstances that drive HIV transmission.