December 22, 2021
PAR-20-092- Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional)
National Institute on Drug Abuse (NIDA)
Purpose
The purpose of this NOSI is to inform grant applicants that the PAR-20-092 includes the development of medications to prevent and treat opioid use disorders and overdose alone or in combination with stimulant use. The reason for this expansion is the dramatic increase in the prevalence of comorbid opioid and stimulant use and use disorders and the morbidity and mortality of co-use of opioids and stimulant drugs like cocaine and methamphetamine.
Background
There is a devastating opioid use and overdose crisis in the United States, which has been complicated by the increasing use and overdoses with stimulant drugs such as cocaine and methamphetamine. Although there are safe and effective pharmacotherapies for opioid use disorders and to prevent/reverse overdose, there is room to improve them. The PAR-20-092 has been very successful in increasing the research on new promising medications that may be safer and more effective that those currenly available to clinicians. However, there are no medications approved by the FDA to treat stimulant use disorders and there are no antidotes to effectively and specifically treat overdoses due to stimulant drugs. It is expected that this NOSI will stimulate research on new or repurposed medications to treat stimulant use disorders and overdose.
The goal is to support preclinical and clinical research studies that will have high impact and quickly yield the necessary results to advance closer to FDA approval, medications that are safe and effective to prevent and treat stimulant use disorders (StUD) and overdose, alone or in combination with opioid use disorder and overdose.
Applications submitted in response to this FOA should focus on studying new chemical entities (NCEs), medications already marketed for other indications, biologics (e.g., vaccines, monoclonal antibodies) or combination of medications.
There is particular interest in the development of compounds for indications such as:
- Prevention of initiation of StUD and Prevention of progression of the severity of StUD
- Facilitation of stimulant use discontinuation and abstinence initiation
- Treatment of stimulant use withdrawal syndrome
- Treatment of pregnant and postpartum women with StUD and their neonates.
- Reduction of lethality of stimulant overdose
- Treatment of stimulant overdose
- Treatment of comorbid opioid and stimulant use disorder
- Treatment of concurrent opioid and stimulant overdose
Application and Submission Information
This notice applies to due dates on or after January 30, 2022 and subsequent receipt dates through September 25, 2022.
Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcement through the expiration date of this notice.
PAR-20-092 Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional)
All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:
- For funding consideration, applicants must include NOT-DA-22-049
Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.
Scientific/Research Contact(s)
Ivan D. Montoya, M.D., M.P.H.
National Institute on Drug Abuse (NIDA)
Telephone: 301-827-5936
Email: imontoya@mail.nih.gov
and Human Services (HHS)
