Developing Digital Therapeutics for Substance Use Disorders (UG3/UH3 Clinical Trial optional)

Active
Yes
Status
Posted
Published Date
February 27th, 2024
Close Date
November 19th, 2026
Opportunity No.
PAR-24-064

Agency

National Institutes of Health (HHS-NIH11)

Eligible Applicants

Others

Funding Category

Health

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Summary

The National Institutes of Health is offering a federal grant opportunity titled "Developing Digital Therapeutics for Substance Use Disorders (UG3/UH3 Clinical Trial optional)". This grant aims to accelerate the development of Digital Therapeutics (DTx) to treat Substance Use Disorders (SUDs). DTx refers to clinical-grade mobile, web, or other software-based platforms designed to deliver safe and effective treatments for SUDs. The goal is to generate new, FDA authorized, disseminated treatments for SUDs by moving DTx to their next step in the development process. This opportunity allows for the focus on pre-clinical and/or clinical development and testing of new DTx or existing DTx developed for other indications. Eligible applicants include various institutions and organizations. The deadline for application submission is November 19, 2026. For more information and to apply, visit the following link: Developing Digital Therapeutics for Substance Use Disorders Grant. For any inquiries, contact NIH Grants Information at grantsinfo@nih.gov.

Description

The purpose of this Funding Opportunity Announcement (FOA) is to accelerate the development of Digital Therapeutics (DTx) to treat Substance Use Disorders (SUDs). Advances in technology offer unprecedented opportunities to develop clinical-grade mobile, web, or other software-based platforms designed to deliver treatments that are safe and effective for SUD. FDA authorization of DTx can play an important role in increasing the availability of treatments to patients with SUD, although there are other pathways for dissemination of this class of intervention. The primary objective of this FOA is to move DTx to their next step in the development process, with the ultimate goal of generating new, FDA authorized, disseminated treatments for SUDs. Applications may focus on the pre-clinical and/or clinical development and testing of new DTx or existing DTx developed for other indications.

Contact Information

Attachments
0 KB

Opportunity Lifecycle

Title
Type
Grant

Similar Opportunities

Device Based Treatments for Substance Use Disorders (UG3/UH3 Clinical Trial Optional)
National Institutes of Health
The National Institutes of Health is offering a federal grant for the development of device-based treatments for Substance Use Disorders (SUDs). This funding opportunity aims to accelerate the advancement of neuromodulatory or neurophysiological devices that can provide safe and effective treatments for SUDs. The objective is to move these devices to the next step in the FDA approval process, ultimately generating new FDA-approved device-based treatments for SUDs. The grant does not require cost sharing or matching. The opportunity falls under the category of Health and is a discretionary grant. The eligible applicants include various institutions and organizations such as Alaska Native and Native Hawaiian Serving Institutions, Faith-based or Community-based Organizations, and U.S. Territories or Possessions. The closing date for applications is August 13, 2026. For more information and to apply, visit the following link: [Device Based Treatments for Substance Use Disorders Grant](http://grants.nih.gov/grants/guide/pa-files/PAR-23-253.html). For any inquiries, contact NIH Grants Information at grantsinfo@nih.gov.
Grand Opportunity in Medications Development for Substance-Use Disorders (U01 Clinical Trial Optional)
National Institutes of Health
The National Institutes of Health (NIH) has posted a grant opportunity titled "Grand Opportunity in Medications Development for Substance-Use Disorders (U01 Clinical Trial Optional)". This funding opportunity aims to accelerate the development of medication for the treatment of Substance Use Disorders (SUDs) by supporting a diverse array of preclinical and/or clinical research projects. The goal is to fund medication studies that will have a high impact and quickly yield the necessary results to advance medications closer to FDA approval. The funding will be in the form of short-term (up to 3 years) and large (up to $5 million per year) cooperative agreements with close monitoring and significant scientific involvement of NIDA staff. This opportunity will enable critical medications development studies that would not be feasible using the traditional R01 activity code. Eligible applicants include 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), and U.S. Territory or Possession. The grant has a closing date of September 1, 2025, and an award ceiling of $5,000,000. For more information and to apply, visit the following link: [Grant Opportunity Details](https://grants.nih.gov/grants/guide/pa-files/PAR-22-202.html). For any inquiries, contact NIH Grants Information at grantsinfo@nih.gov.
Establishing a Center for the Advancement of Substance Use Disorder (SUD) Pharmacotherapeutics (U54 Clinical Trials Not Allowed)
National Institutes of Health
The National Institutes of Health (NIH) has posted a grant opportunity titled "Establishing a Center for the Advancement of Substance Use Disorder (SUD) Pharmacotherapeutics (U54 Clinical Trials Not Allowed)". This grant aims to address the lack of early translational funding and technical support for new product developers in the field of substance use disorder (SUD) pharmacotherapeutics. The grant seeks to establish a technical development center (or centers) that will provide researchers with the necessary support to move their ideas beyond the conceptual stage and into product development. This support includes assistance in target product profile development, clinical need assessment, project plan development, prototype development, proof-of-concept study design, preliminary safety assessments, and guidance on current and future regulatory requirements. The funding instrument for this grant is a Cooperative Agreement, and there is no cost sharing or matching requirement. The grant falls under the category of Health and is open to various eligible applicants, including 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, non-domestic entities (foreign organizations), regional organizations, Tribally Controlled Colleges and Universities (TCCUs), and U.S. Territories or Possessions. The closing date for this grant opportunity is November 13, 2024. The maximum award ceiling is $1,900,000. For more information and to apply, interested parties can visit the following website: [http://grants.nih.gov/grants/guide/rfa-files/RFA-DA-25-056.html](http://grants.nih.gov/grants/guide/rfa-files/RFA-DA-25-056.html). For any inquiries, the contact email is grantsinfo@nih.gov.
Development of Medications to Prevent and Treat Opioid and/or Stimulant Use Disorders and Overdose (UG3/UH3 - Clinical Trial Optional)
National Institutes of Health
The National Institutes of Health is offering a federal grant opportunity titled "Development of Medications to Prevent and Treat Opioid and/or Stimulant Use Disorders and Overdose (UG3/UH3 - Clinical Trial Optional)". This grant aims to support the discovery and development of medications to prevent and treat opioid and/or psychostimulant use disorders and overdose. The funding instrument type for this opportunity is a Cooperative Agreement. The grant falls under the category of funding activity related to health. The grant does not require cost sharing or matching. The eligible applicants for this grant include various institutions and organizations such as 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), and U.S. Territory or Possession. The purpose of this grant is to support the discovery and development of medications that can prevent and treat opioid and/or psychostimulant use disorders and overdose. The grant involves two phases, UG3 and UH3. The UG3 phase provides support for a project with specific milestones to be accomplished within a 2-year period. The UH3 phase provides funding for 3 years to a project that successfully completes the milestones set in the UG3 phase. Projects that meet their milestones in the UG3 phase will be considered for transition to the UH3 phase. The grant encourages applications that include preclinical or clinical research studies with high impact and quick results to advance medications closer to FDA approval for the prevention and treatment of opioid use disorders and overdose. The compounds to be evaluated can be small molecules or biologics, and they can be tested in pre-clinical models or for the clinical manifestations of opioid use disorders such as withdrawal, craving, relapse, or overdose. The grant also supports the development of new chemical entities, new formulations of marketed medications available for other indications, or combinations of medications that hold promise for the treatment of opioid use disorders and overdose. The goal of this grant is to fast-track the discovery and development of medications to prevent and treat opioid use disorders or opioid overdose and advance them in the FDA's drug development approval pipeline. For more information and to apply for this grant opportunity, please visit the following link: [Development of Medications to Prevent and Treat Opioid and/or Stimulant Use Disorders and Overdose (UG3/UH3 - Clinical Trial Optional)](http://grants.nih.gov/grants/guide/pa-files/PAR-22-200.html). If you have any inquiries, you can contact NIH Grants Information at grantsinfo@nih.gov.