Grant Details

General Overview

Grant Information

Grant name: Grand Opportunity in Medications Development for Substance-Use Disorders (U01 Clinical Trial Optional)

Funding organization: National Institutes of Health (NIH)

Total funding amount: Up to $5 million per year

Duration: Maximum of 3 years

Primary objective: Support research to advance the development of safe and effective medications for the treatment of Substance Use Disorders (SUD).

Key stakeholders: National Institute on Drug Abuse (NIDA), researchers, and organizations involved in SUD treatment.

Funding source: Federal government.

Funding type: Cooperative agreements.

Significance: Addresses urgent public health needs for effective SUD treatments.

Grant frequency: Recurring.

Organizational Aspects

Eligible Organization Types

Higher Education Institutions

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Small Businesses

Local Governments

State Governments

County Governments

City or Township Governments

Indian/Native American Tribal Governments (Federally Recognized)

Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Government Agencies

U.S. Territories or Possessions

Other: Independent School Districts, Public Housing Authorities, Faith-based Organizations, Regional Organizations, Foreign Organizations.

Specific Qualifications

Organizations must complete registrations with System for Award Management (SAM), eRA Commons, and Grants.gov.

All Program Directors/Principal Investigators (PDs/PIs) must have an eRA Commons account.

Scope and Focus

Research Objectives

Focus on developing compounds for treating SUDs including opioids, methamphetamine, cocaine, nicotine, and cannabis.

Applications must provide entry and exit points in the FDA approval pathway.

Expected Outcomes

Advancement of medications closer to FDA approval.

High-impact studies yielding necessary results.

Technical Details

Technical Expertise Requirements

Research in chemistry, pharmaceutics, preclinical and clinical development.

Use of AI/ML tools for medication development.

Financial Structure

Budget and Funding

Application budgets are limited to $5 million per year.

No cost-sharing required.

Timeline and Implementation

Key Dates

Application due date: August 11, 2025.

Earliest start date: April 10, 2025.

Compliance and Requirements

Regulatory Compliance

Compliance with NIH Grants Policy Statement.

Adherence to ethical standards and regulations.

Application Process

Submission Requirements

Applications must be submitted electronically via Grants.gov.

Follow the instructions in the How to Apply - Application Guide.

Special Considerations

Non-responsive Applications

Applications evaluating psychosocial interventions will not be reviewed.

Applications addressing alcohol as the only substance of use will not be reviewed.

Grant Details

substance use disorders medications development clinical trials healthcare research funding public health drug addiction pharmaceuticals biologics AI in healthcare
Grand Opportunity in Medications Development for Substance-Use Disorders (U01 Clinical Trial Optional)
PAR-25-328
NIH Grants
EDU NGO ENTERPRISE PUBLIC RESEARCH OTHER
US
HEALTHCARE OTHER
DEVELOPMENT OTHER
OTHER
SDG3
FUNDING RESEARCH_DEVELOPMENT
None
5000000.00
None
5000000.00
USD
None
Aug. 11, 2025, 5 p.m.
July 2025 - October 2025