Key Dates

Related Announcements

• November 8, 2023 - Phased Research to Support Substance Use Epidemiology, Prevention, and Services Studies (R61/R33 Clinical Trials Optional). See NOFO PAR-24-062

Issued by

National Institute on Drug Abuse (NIDA)

Purpose

The purpose of this Notice is to inform potential applicants of the updates for PAR-24-062, "Phased Research to Support Substance Use Epidemiology, Prevention, and Services Studies (R61/R33 Clinical Trials Optional)".

The following sections of PAR-24-062 have been updated to reflect the new dates and content:

Part 1. Overview Information

Key Dates
 

Currently reads:

All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

     Expiration Date

     November 14, 2026

Modified to Read: (changes in bold Italic)

All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

     Expiration Date

     December 15, 2026

Part 1. Overview Information

Funding Opportunity Purpose

Currently reads:

The purpose of this notice of this funding opportunity (NOFO) is to support translational research across epidemiology, addiction services, and prevention to, ultimately, reduce the burden of substance use on public health. This NOFO encourages research that facilitates rapid translation from one discipline to another (e.g., epidemiology to prevention); supports community/stakeholder engagement in substance use treatment and prevention clinical trials; or reduces the research to practice gap through the rapid transition from pilot study to clinical trial, or effectiveness to implementation study.  The goal is to support translational research improving our ability to  1) identify and characterize malleable individual, familial, behavioral, developmental, and socio-cultural/environmental factors (within the population or precise subgroups) with the potential for multi-directional transfer of knowledge;  2) prevent initiation of substance use or progression to misuse or use disorder; and 3) maximize the efficient delivery of high-quality, personalized addiction treatment and related services to ultimately inform and facilitate real world responses designed to reduce the burden of substance use, misuse and/or addiction on the health of the population. This NOFO invites projects for which preliminary feasibility or pilot data are not available.

Modified to read: (changes in bold Italic)

The purpose of this notice of this funding opportunity (NOFO) is to support translational research across epidemiology, addiction services, and prevention to, ultimately, reduce the burden of substance use on public health. This NOFO encourages research that facilitates rapid translation from one discipline to another (e.g., epidemiology to prevention); supports community/stakeholder engagement in substance use treatment and prevention clinical trials; or reduces the research to practice gap through the rapid transition from pilot study to clinical trial, or effectiveness to implementation study.  The goal is to support translational research improving our ability to 1) identify and characterize malleable individual, familial, behavioral, developmental, and socio-cultural/environmental factors (within the population or precise subgroups) with the potential for multi-directional transfer of knowledge; 2) prevent initiation of substance use or progression to misuse or use disorder; 3) maximize the efficient delivery of high-quality, personalized addiction treatment and related services to ultimately inform and facilitate real world responses designed to reduce the burden of substance use, misuse and/or addiction on the health of the population; and 4) advance understanding of the intersection of HIV and substance use in order to prevent substance-related acquisition or transmission of HIV infection and viral hepatitis. This NOFO invites projects for which preliminary feasibility or pilot data are not available.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Currently reads:

Purpose

The National Institutes of Health (NIH) advances science on alcohol and substance use to improve health through effective intervention, epidemiological, translational, and services research. The National Institute on Drug Abuse (NIDA) and National Institute on Alcohol Abuse and Alcoholism (NIAAA) support science across a continuum of research portfolios related to epidemiology/etiology, prevention, treatment, recovery, and harm reduction.

This NOFO aims to: 1) advance substance use research priorities related to rapid translation from one discipline to another (e.g., epidemiology to prevention); 2) facilitate community/stakeholder engagement in substance use treatment and prevention clinical trials; and 3) reduce the research to practice gap through the rapid transition from pilot study to clinical trial or effectiveness to implementation study. Applications in response to this NOFO will require a phased approach, with 1-2 years of preparatory work during the R61 phase prior to transitioning to the R33 phase to conduct a larger study. Projects must meet relevant milestones outlined in the R61 phase of the project in order to transition to the R33 phase.  Phased awards do not require pilot or feasibility data at the time of submission, and transition to Phase 2 is not guaranteed.

Research Objectives

Below are examples of broad types of research that may be appropriate under this NOFO. Investigators are also encouraged to review existing NOFOs, NOSIs and the  NIDA and  NIAAA websites for additional details on high priority research areas of interest.

Types of studies include, but are not limited to:

• A pilot test of a promising intervention in a new population/setting that transitions to a larger implementation/effectiveness trial.
• Epidemiologic research that supports the development and/or testing of a novel or adapted intervention to prevent substance use initiation, misuse, or use disorder.
• Epidemiologic research that supports the testing of an adapted intervention to treat substance use disorder, support recovery, or provide harm reduction services.
• A community-driven study that includes engagement of community experts and co-creation of research methods in the planning phase, then transitions to a study of the impact of a policy or program to address substance use.
• A multi-site implementation study requiring a planning phase to prepare multiple sites for implementation, then transition to a large trial with the intervention administered across diverse settings/organizations.

Applications should propose rigorous methods that are appropriate to the area of science (epidemiology, services, prevention). Applications that are innovative and do not focus on replicating previous findings will be prioritized. Key elements that applicants should consider include:

• Diverse and/or multi-disciplinary teams, including meaningful engagement of relevant practitioners and community stakeholders in study conceptualization, design, execution, and interpretation.
• Potential scalability and sustainability of the proposed intervention, if included, including perspectives of prospective funders/payers, workforce/practitioners, organizational or policy leaders, and patients/community members should the proposed intervention prove to be successful.
• The role of health disparities and inequities and their relevance to the phenomena, populations, settings, interventions, or services being studied.

To maximize the acceptability, feasibility, scalability, and sustainability of prevention or treatment services being studied, applicants are encouraged to engage relevant end users in study conceptualization, design, execution, and interpretation. For the purpose of this NOFO, end user is broadly defined and may include policymakers, state and local level decision makers, practitioners, intervention implementers, families, youth, and community members, among others. For instance, applicants may partner with communities and localities who use existing funds (e.g., insurance; entitlement programs; federal block grants; settlement funds) to support evidence-based interventions and leverage those resources as the foundation for building infrastructure. Additionally, applicants may consider partnering with settings or organizations that receive SAMHSA program grants, in an effort to study programs leveraging existing federal funds and determine the impact of current federal investment.

National Institute on Drug Abuse (NIDA) Priorities

The NIDA 2022-2026 Strategic Plan outlines the Institute’s mission to advance science on substance use and addiction and improve health through effective intervention, epidemiological, translational, and services research that can be disseminated and implemented on a broad scale. The Strategic Plan identifies the need to: 1) Test interventions across the continuum; 2) Improve our understanding of substance use, behavior, and social determinants to better understand targets of intervention; and 3) Support research to ensure evidence-based decisions, strategies, and approaches are implemented by systems as broadly and rapidly as possible to improve health.

NIDA’s Division of Epidemiology, Services and Prevention Research (DESPR) advances the NIDA mission by supporting research across the continuum of epidemiology, prevention, services, recovery, and harm reduction to reduce the impact of substance use and improve public health. Each of DESPR’s three branches – the Epidemiology Research Branch, the Services Research Branch, and the Prevention Research Branch – identify and update priority areas of science on the NIDA website.

Modified to read: (changes in bold Italic)

Purpose

The National Institutes of Health (NIH) advances science on alcohol and substance use to improve health through effective intervention, epidemiological, translational, and services research. The National Institute on Drug Abuse (NIDA) and National Institute on Alcohol Abuse and Alcoholism (NIAAA) support science across a continuum of research portfolios related to epidemiology/etiology, prevention, treatment, recovery, and harm reduction.

This NOFO aims to: 1) advance substance use research priorities related to rapid translation from one discipline to another (e.g., epidemiology to prevention); 2) facilitate community/stakeholder engagement in substance use treatment and prevention clinical trials; 3) reduce the research to practice gap through the rapid transition from pilot study to clinical trial or effectiveness to implementation study; and 4) advance understanding of the intersection of HIV and substance use in order to prevent substance-related acquisition or transmission of HIV infection and viral hepatitis.  Applications in response to this NOFO will require a phased approach, with 1-2 years of preparatory work during the R61 phase prior to transitioning to the R33 phase to conduct a larger study. Projects must meet relevant milestones outlined in the R61 phase of the project in order to transition to the R33 phase.  Phased awards do not require pilot or feasibility data at the time of submission, and transition to Phase 2 is not guaranteed.

Research Objectives

Below are examples of broad types of research that may be appropriate under this NOFO. Investigators are also encouraged to review existing NOFOs, NOSIs and the  NIDA and  NIAAA websites for additional details on high priority research areas of interest.

Types of studies include, but are not limited to:

• A pilot test of a promising intervention in a new population/setting that transitions to a larger implementation/effectiveness trial.
• Epidemiologic research that supports the development and/or testing of a novel or adapted intervention to prevent substance use initiation, misuse, or use disorder and associated HIV infections.
• Epidemiologic research that supports the testing of an adapted intervention to treat substance use disorder, support recovery, or provide harm reduction services.
• A community-driven study that includes engagement of community experts and co-creation of research methods in the planning phase, then transitions to a study of the impact of a policy or program to address substance use, HIV, and viral hepatitis infection.
• A multi-site implementation study requiring a planning phase to prepare multiple sites for implementation, then transition to a large trial with the intervention administered across diverse settings/organizations.

Applications should propose rigorous methods that are appropriate to the area of science (epidemiology, services, prevention). Applications that are innovative and do not focus on replicating previous findings will be prioritized. Key elements that applicants should consider include:

• Diverse and/or multi-disciplinary teams, including meaningful engagement of relevant practitioners and community stakeholders in study conceptualization, design, execution, and interpretation.
• Potential scalability and sustainability of the proposed intervention, if included, including perspectives of prospective funders/payers, workforce/practitioners, organizational or policy leaders, and patients/community members should the proposed intervention prove to be successful.
• The role of health disparities and inequities and their relevance to the phenomena, populations, settings, interventions, or services being studied.

To maximize the acceptability, feasibility, scalability, and sustainability of prevention or treatment services being studied, applicants are encouraged to engage relevant end users in study conceptualization, design, execution, and interpretation. For the purpose of this NOFO, end user is broadly defined and may include policymakers, state and local level decision makers, practitioners, intervention implementers, families, youth, and community members, among others. For instance, applicants may partner with communities and localities who use existing funds (e.g., insurance; entitlement programs; federal block grants; settlement funds) to support evidence-based interventions and leverage those resources as the foundation for building infrastructure. Additionally, applicants may consider partnering with settings or organizations that receive SAMHSA program grants, in an effort to study programs leveraging existing federal funds and determine the impact of current federal investment.

National Institute on Drug Abuse (NIDA) Priorities

The NIDA 2022-2026 Strategic Plan outlines the Institute’s mission to advance science on substance use and addiction and improve health through effective intervention, epidemiological, translational, and services research that can be disseminated and implemented on a broad scale. The Strategic Plan identifies the need to: 1) Test interventions across the continuum; 2) Improve our understanding of substance use, behavior, and social determinants to better understand targets of intervention; and 3) Support research to ensure evidence-based decisions, strategies, and approaches are implemented by systems as broadly and rapidly as possible to improve health.

NIDA’s Division of Epidemiology, Services and Prevention Research (DESPR) advances the NIDA mission by supporting research across the continuum of epidemiology, prevention, services, recovery, and harm reduction to reduce the impact of substance use and improve public health. Each of DESPR’s three branches – the Epidemiology Research Branch, the Services Research Branch, and the Prevention Research Branch – identify and update priority areas of science on the NIDA website. NIDA’s HIV Research Program provides HIV-related priorities on its website.

All other aspects of this NOFO remain the same.

Inquiries

Please direct all inquiries to:

Amy B. Goldstein, PhD
National Institute on Drug Abuse (NIDA)
Phone: 301-827-4124
Email: amy.goldstein@nih.gov