Key Dates

Related Announcements

• May, 07, 2020 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed). See NOFO PA-20-195
• May, 07, 2020 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required). See NOFO PA-20-194
• May, 07, 2020 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Basic Experimental Studies with Humans Required). See NOFO PA-20-196
• May, 07, 2020 - NIH Small Research Grant Program (Parent R03 Clinical Trial Not Allowed). See NOFO PA-20-200
• May, 05, 2020 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed). See NOFO PA-20-185
• May, 05, 2020 - Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required). See NOFO PA-20-184
• May, 05, 2020 - Research Project Grant (Parent R01 Clinical Trial Required). See NOFO PA-20-183

Issued by

National Institute on Drug Abuse (NIDA)

Purpose

The opioid epidemic has led to a rise in opioid misuse among pregnant women posing unique challenges and risks to maternal and especially fetal health. Little is known about prenatal effects of fentanyl, a synthetic opioid increasingly present in unregulated drug supply and increasingly misused during pregnancy.

Given the pharmacology of fentanyl, its use during pregnancy may produce unique effects in the fetus and newborn. Preclinical studies of prenatal fentanyl exposure in rodent models revealed smaller litter sizes and higher litter mortality rates of pups, and somatosensory impairments in surviving animals. 

In humans, fentanyl transfer across placenta was documented in early pregnancies, and the drug was confirmed in fetal brain tissue. A single-center, retrospective cohort study revealed prenatal fentanyl as one of the risk factors most strongly associated with the need for inotrope treatment in hypotensive very low gestational age infants. Even more worrying is the recent report on a novel syndrome associated with prenatal fentanyl exposure. Ten newborns, all prenatally exposed to nonprescription fentanyl, shared microcephaly, distinctive facial features, cleft palate, feeding difficulties, and congenital anomalies of hands and feet. The similarity with Smith-Lemli-Opitz syndrome (SLOS), suggests abnormalities in prenatal cholesterol metabolism, but the mechanism through which fentanyl might interfere with cholesterol synthesis is unclear.

The purpose of this Notice of Special Interest (NOSI) is to promote research on neurobehavioral, neurological, and potential teratogenic effects of prenatal fentanyl exposure in humans and in animal models.

Research Areas (may include, but are not limited to):

• Potential Prenatal Fentanyl Syndrome: Identification of other cases similar to SLOS and evaluation of their association with prenatal fentanyl and other risk factors
• Epidemiology: other adverse birth outcomes in babies prenatally exposed to fentanyl; the prevalence, the dose-response relationship, modifying factors including exposure to other unregulated drugs, etc
• Human development: long-term health and behavioral consequences of prenatal fentanyl exposure in infants and children
• Preclinical models: development of a preclinical model of prenatal fentanyl exposure, anatomical, physiological and neurobehavioral characterization of the offspring
• Mechanism: examination of fentanyl effects on cholesterol metabolism and other processes through which prenatal fentanyl may exert its negative effects on embryonic development
• Developmental consequences: long-term neurobiological consequences of prenatal fentanyl exposure in animal models
• Therapy: exploration of treatment and/or options for medical management mitigate negative consequence of prenatal fentanyl exposure in children

Application and Submission Information

This notice applies to due dates on or after June 5, 2025 and subsequent receipt dates through September 8, 2028. 

Submit applications for this initiative using one of the following notice of funding opportunity (NOFO) or any reissues of these announcements through the expiration date of this notice.

• PA-20-185 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
• PA-20-184 - Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required)
• PA-20-183 - Research Project Grant (Parent R01 Clinical Trial Required)
• PA-20-195 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)
• PA-20-194 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)
• PA-20-196 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Basic Experimental Studies with Humans Required)
• PA-20-200 - NIH Small Research Grant Program (Parent R03 Clinical Trial Not Allowed) 

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-26-003” (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.

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)

Jana Drgonova, Ph.D.
NIDA/DTMC
Telephone: 301-827-5933
Email: jana.drgonova@nih.gov