Key Dates

Related Announcements

PAR-22-202 - Grand Opportunity in Medications Development for Substance-Use Disorders (U01 Clinical Trial Optional)

Issued by

National Institute on Drug Abuse (NIDA)

Purpose

Background

The NIH HEAL initiative aims to speed the development and implementation of scientific solutions to the national opioid public health crisis by bolstering research across NIH to (1) improve treatment for opioid and co-occurring stimulant misuse and addiction and (2) enhance pain management. More information and periodic updates about the HEAL Initiative are available at: https://heal.nih.gov/.

The PAR-22-202 - Grand Opportunity in Medications Development for Substance-Use Disorders (U01 Clinical Trial Optional) seeks to accelerate the development of medication for the treatment of opioid and/or stimulant use disorders or overdose by encouraging research applications to support a diverse array of preclinical and/or clinical research projects. The goal is to fund medication studies that will have high impact and quickly yield the necessary results to advance medications closer to FDA approval.

Research Objectives

The purpose of this Notice of Special Interest (NOSI) is to seek research applications that focus on the scientific scope of the Helping to End Addition Long-term (HEAL) initiative (https://heal.nih.gov/) to be submitted under the PAR-22-202 titled "Grand Opportunity in Medications Development for Substance-Use Disorders (U01 - Clinical Trial Optional)". Grant applications responsive to this NOSI can only evaluate medications to prevent or treat opioid and/or stimulant (cocaine or methamphetamine) use disorders or overdose. Applications focusing on other SUDs are not eligible.

Grant applications may seek support for an array of preclinical and/or clinical research projects. They can include the evaluation of new chemical entities (NCEs), already-marketed medications, biologics (i.e., vaccines, antibodies, enzymes, gene therapies, etc.), combinations of medications, and/or new medication delivery devices/technologies.

The medications investigated for SUDs may target one or more of the neuropathological mechanisms, the various clinical stages, and/or the medical/psychiatric complications of opioid/stimulant use disorders and overdose.

Research is encouraged, but not limited, to studies in the following areas:

• Chemistry and Pharmaceutics: lead compound optimization, creation/expansion of small molecular libraries, high-throughput screening, medicinal chemistry, formulation or drug-delivery technology, prodrug, proteinaceous (e.g., vaccines and antibodies), and/or bioassay development of potential medications for SUDs
• Preclinical Development: drug interaction studies between medications and drugs of abuse and evaluation of safety and/or efficacy in established animal models, as well as pharmacokinetic and pharmacodynamic studies of potential pharmacotherapies for opioid/stimulant use disorders and overdose.
• Clinical Development: Phase I - Evaluation of the pharmacokinetics, safety, tolerability, dose-ranging, and/or initial efficacy in human subjects. Phase II - Proof-of-concept, pilot studies, safety and efficacy testing in a larger sample of human subjects. Phase III - Safety and efficacy of medications tested in a large sample of patients

Applications should provide the entry and exit points of the proposed research in the FDA approval pathway.

Applications are expected to involve individuals seeking treatment including behavioral therapy; however, the scope of this FOA does not include the evaluation of the safety and/or efficacy of psychosocial interventions.

Awardees are also expected to make their individual datasets and aggregated datasets available for data sharing to other investigators when appropriate.

NIDA Program Officials will be substantially involved in the scientific direction of the award in a partnership role. The NIDA Program Scientists will collaborate on developing common measures, procedures and data management protocols, monitor study progress, ensure disclosure of conflicts of interest and adherence to HEAL, NIDA and NIH policies, and participate in data analysis and manuscript preparation as appropriate.

It is expected that these U01s will be short-term (funded for up to 3 years) and large (up to $5 million per year) cooperative agreements with close monitoring and significant scientific involvement of NIDA staff.

Special Considerations:

In addition to scientific diversity, applicants should strive to incorporate diversity in their team development plan. Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust. In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups that are underrepresented in the biomedical, clinical, behavioral, and social sciences. Please refer to Notice of NIH's Interest in Diversity NOT-OD-20-031 for more details.

The NIH HEAL Initiative will require a high level of coordination and sharing between investigators. It is expected that NIH HEAL Initiative awardees will cooperate and coordinate their activities after awards are made by participating in Program Director/Principal Investigator (PD/PI) meetings, including an annual HEAL Investigators Meeting, as well as other activities.

NIH intends to maximize the impact of HEAL Initiative-supported projects through broad and rapid data sharing.Consistent with the HEAL Initiative Public Access and Data Sharing Policy (https://heal.nih.gov/about/public-access-data), all applications, regardless of the amount of direct costs requested for any one year, are required to include a Data Management and Sharing Plan outlining how scientific data and any accompanying metadata will be managed and shared. The plan should describe data types, file formats, submission timelines, and standards used in collecting or processing the data. Data generated by HEAL Initiative-funded projects must be submitted to study-appropriate domain-specific or generalist repositories in consultation with the HEAL Data Stewardship Group to ensure the data is accessible via the HEAL Initiative Data Ecosystem. Guidelines for complying with the HEAL Public Access and Data Sharing Policy can be found at https://heal.nih.gov/data/complying-heal-data-sharing-policy. Resources and tools to assist with data related activities can be found at https://www.healdatafair.org/.

To maximize discoverability and value of HEAL datasets and studies, and facilitate data integration and collaboration, applications submitted in response to this FOA are strongly encouraged to incorporate standards and resources where applicable:

• Applicants are encouraged to ensure that data collected by the study conform to Findable, Accessible, Interoperable, and Reusable (FAIR) principles.
• Applicants are specifically encouraged to incorporate into their planning, an alignment with the guidelines, principles and recommendations developed by the HEAL Data Ecosystem, including but not limited to preparing data to store in selected specified repositories, applying minimal metadata standards, use of core HEAL Clinical Data Elements (CDEs, https://heal.nih.gov/data/common-data-elements), and other necessary requirements to prepare data to connect to the HEAL Data Ecosystem.

• To the extent possible, HEAL awardees are expected to integrate broad data sharing consent language into their informed consent forms and align study consent language with data access and re-use requirements as defined by repository HEAL investigators select to store their HEAL data long-term.

The NIH notices referenced below provide additional NIH guidance that should be considered in developing a strong data management and sharing plan. The list is instructive but not comprehensive.

• Elements of an NIH Data Management and Sharing Plan (NOT-OD-21-014)
• NIH has provided guidance around selecting a repository for data generated by NIH-supported research and has developed desirable characteristics for all data repositories (NOT-OD-21-016).
• NIH encourages the use of data standards including the PhenX Toolkit (www.phenxtoolkit.org) (for example, see NOT-DA-12-008, NOT-MH-15-009)
• Data should be organized according to a standard model that is widely accepted within the field. An example for the clinical research studies would be the OMOP Common Data Model, which has also been successfully adapted for use with observational (including survey) studies more generally. In addition, the HL7 FHIR® (Fast Healthcare Interoperability Resources) standard (NOT-OD-19-122) may facilitate the flow of data with EHR-based datasets, tools, and applications.
• NIH encourages clinical research programs and researchers to adopt and use the standardized set of data classes, data elements, and associated vocabulary standards specified in the United States Core Data for Interoperability (USCDI) standards, as they are applicable (NOT-OD-20-146). Use of the USCDI can complement the FHIR® standard and enable researchers to leverage structured EHR data for research and enable discovery. In addition to USCDI, OMOP, and FHIR standards for enhanced interoperability, investigators and data centers should align their data collection and management practices with recommended guidance emerging from the HEAL CDE and Data Ecosystem programs.

Awardees conducting research that includes collection of genomic data should incorporate requirements under the NIH Genomic Data Sharing Policy (NOT-OD-14-124, NOT-OD-15-086).

The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities

Application and Submission Information

This notice applies to due dates on or after Octember 27, 2022 2022 and subsequent receipt dates through September 2, 2025.

Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcement through the expiration date of this notice.

• PAR-22-202 -Grand Opportunity in Medications Development for Substance-Use Disorders (U01 Clinical Trial Optional)

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

• For funding consideration, applicants must include “NOT-DA-23-009” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.

Inquiries

Ivan Montoya, M.D., M.P.H.
Natinal Institute on Drug Abuse (NIDA)
Telephone: 301-827-5936
Email: imontoya@mail.nih.gov