• Approved

• NIDA

• Cooperative Agreement

• Small Businesses
• Corporations
• Institutes of Higher Education (IHE) / Colleges & Universities
• Federal Agencies
• Non-profit, non-academic organizations

• SAM
• GRANTS

Funding Opportunity Goal(s)
To support basic, clinical, translational, and implementation research in the field of substance use. To develop new knowledge and approaches for the prevention, diagnosis, and treatment of drug use, misuse, and addiction, drug overdose, and related health outcomes, including HIV/AIDS.

Background

Over 40 million people in the United States have a substance use disorder (SUD). Drug overdose is the leading cause of accidental death, with an estimated 105,000 deaths in 2023. Deaths involving synthetic opioids other than methadone (primarily fentanyl), amphetamine-type psychostimulants (primarily methamphetamine), and cocaine were estimated to be 71%, 33%, and 27%, respectively. Furthermore, 48% of the 2022 overdose deaths were attributed to a synthetic opioid and another non-opioid substance (i.e., polysubstance overdose). Thus, there is an urgent need to develop safe and effective interventions to prevent and treat SUDs and overdose. These needed interventions include medications, digital therapeutics (DTx), device-based treatments, and behavioral interventions.

Research Focus

The National Institute on Drug Abuse (NIDA) seeks preclinical and clinical research studies that will have high impact and quickly yield the necessary results to advance candidate interventions to prevent or treat SUDs and overdose closer to the Food and Drug Administration (FDA) approval/authorization/clearance and/or implementation into clinical practice and community care.

There is particular interest in the development of therapeutic interventions for:

Prevention of initiation of SUDs
Prevention of progression of the severity of SUDs
Reduction of the dose of opioids analgesics
Improvement of SUD treatment adherence
Facilitation of substance use discontinuation
Treatment of drug withdrawal signs and symptoms
Treatment of neonatal drug withdrawal
Treatment of co-morbid SUDs
Reduction of lethality of overdose
Reduction of overdose relapse
Reduction of the risk of substance-induced respiratory depression
Any other behavioral and medical manifestations or consequences of SUDs or overdose
Single or multiple comorbid SUDs
Populations at high risk for SUDs
Because the development of SUD interventions is likely to be high risk, UG3/UH3 grant applications must provide clear milestones to be accomplished at the end of the UG3 phase. Objective milestones of success and go/no-go rules for medications development progression are required, and both must have quantitative criteria associated with them.

Using these methods (More details in NOFO)
Pharmacotherapies
Device-Based Treatments
Digital Therapeutics (DTx)
Behavioral Interventions

Applications Not Responsive to this NOFO

The following types of studies are not responsive to this NOFO and will not be reviewed:

Applications focusing solely on novel target identification/validation, generation of new animal models, development/testing of new human laboratory models
Applications focusing on mechanistic studies of the neurobiology of addiction
Applications that address alcohol as the only substance of use
Applications related to behavioral interventions in stages IV, V, or VI
Applications focusing on effectiveness research
Applicants should consult with NIDA staff when developing plans for an application (see Agency Contacts, Section VII). This early contact will provide an opportunity to clarify NIDA policies and guidelines, identify whether the proposed project is consistent with NIDA program priorities, and discuss how to develop an appropriate project timeline, which is subject to peer review.