Key Dates

Related Announcements

• September 1, 2022 - Grand Opportunity in Medications Development for Substance-Use Disorders (U01 Clinical Trial Optional). See NOFO PAR-22-202.
• September 1, 2022 - Development of Medications to Prevent and Treat Opioid and/or Stimulant Use Disorders and Overdose (UG3/UH3 - Clinical Trial Optional). See NOFO PAR-22-200.
• November 29, 2021 - Drug Discovery For Nervous System Disorders (R01 Clinical Trials Not Allowed). See NOFO PAR-22-031.
• May 7, 2020 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Basic Experimental Studies with Humans Required). See NOFO PA-20-196
• May 7, 2020 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed). See NOFO PA-20-195.
• May 7, 2020 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required). See NOFO PA-20-194.
• May 5, 2020 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed). See NOFO PA-20-185.
• May 5, 2020 - Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required). See NOFO PA-20-184.
• May 5, 2020 - Research Project Grant (Parent R01 Clinical Trial Required). See NOFO PA-20-183.

Issued by

National Institute on Drug Abuse (NIDA)

National Center for Complementary and Integrative Health (NCCIH)

Purpose

, Natural products (NPs) and NP-like compounds represent a highly diverse and promising chemical space for discovering and developing medications to treat diseases, including central nervous system (CNS) disorders. Despite considerable promise, the search for therapeutic candidates, particularly for addressing substance use disorders (SUDs), has thus far been limited. In addition to addictive behaviors, SUDs may include symptoms that impact the whole person, such as cognitive, affective, sensory, motor, internal organ, and circadian dysregulations, as well as many associated behavioral changes. The National Institute on Drug Abuse (NIDA), in partnership with the National Center for Complementary and Integrative Health (NCCIH), is issuing this Notice of Special Interest (NOSI) to highlight interest in receiving grant applications for innovative NP-focused research involving lead discovery and drug development to address the challenges of SUDs.

Areas of interest suitable for this notice include, but are not limited to:

• Discovery of novel bioactive NPs and chemically complex herbal formulations through use of pre-fractionation and fractionation, NP-like and NP-inspired library generation, cell-free and cell-based screening, and computational tools for rapid compound de-replication and the ability to isolate, identify, and re-supply active compounds rapidly.
• The use of automatic processing of extracts, artificial intelligence and machine learning algorithms, molecular descriptors, likeness scores, chemical space, prediction of biological functions, and de-orphanization and generation of de novo NP-inspired compounds.
• Studying potential NP candidates (including herbal formulations, probiotics, and prebiotics) in preclinical studies and clinical trials to understand the mechanism(s) of action, safety, and efficacy in treating SUDs. For example, non-FDA-regulated psychoactive herbal remedies that are used to relieve pain and mood disorders or as a substitute for substance use, such as cannabis, psychedelics, and kratom, are of interest.
• Research projects on natural products with rigorous evidence of harm reduction.

Application and Submission Information

This notice applies to due dates on or after February 5, 2025 and subsequent receipt dates through January 8, 2029.  Applications for this initiative must be submitted using one of the following notice of funding opportunity (NOFO) or reissues of these announcements through the expiration date of this notice.

• September 1, 2022 - Grand Opportunity in Medications Development for Substance-Use Disorders (U01 Clinical Trial Optional). See NOFO PAR-22-202.
• September 1, 2022 - Development of Medications to Prevent and Treat Opioid and/or Stimulant Use Disorders and Overdose (UG3/UH3 - Clinical Trial Optional). See NOFO PAR-22-200.
• November 29, 2021 - Drug Discovery For Nervous System Disorders (R01 Clinical Trials Not Allowed). See NOFO PAR-22-031.
• May 7, 2020 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Basic Experimental Studies with Humans Required). See NOFO PA-20-196
• May 7, 2020 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed). See NOFO PA-20-195.
• May 7, 2020 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required). See NOFO PA-20-194.
• May 5, 2020 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed). See NOFO PA-20-185.
• May 5, 2020 - Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required). See NOFO PA-20-184.
• May 5, 2020 - Research Project Grant (Parent R01 Clinical Trial Required). See NOFO PA-20-183.

All instructions in the How to Apply - Application Guide and the NOFO used for submission must be followed, with the following additions:

• For funding consideration, applicants must include “NOT-DA-25-032” (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.

The following types of study are nonresponsive to the terms of this NOSI and will be withdrawn from consideration for this initiative:

• Applications that do not address substance use or SUD
• Applications that focus on alcohol use disorder.

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

Inquiries

Please direct all inquiries to the Scientific/Research, Peer Review, and Financial/Grants Management contacts in Section VII of the listed notice of funding opportunity.

Scientific/Research Contact(s)

Jia Bei Wang, MD, Ph.D. 
National Institute on Drug Abuse (NIDA)
Phone: 240-974-4703 
Email: [email protected]

Hoang Le, Ph.D.
National Institute on Drug Abuse (NIDA)
Phone: 301-451-8849
Email: [email protected] 

Patrick C. Still, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-682-1895
Email: [email protected]