The purpose of this Notice is to encourage grant applications proposing research to evaluate potential interactions among substances of abuse, medications to treat Substance Use Disorders (SUDs), and medications to treat HIV infection. The aim is to support pre-clinical and clinical research to study the pharmacokinetic (PK), pharmacodynamic (PD), and toxicological interactions among those three groups of substances.

Results from studies supported by this NOSI are expected to help design safer and individualized treatment strategies for people receiving pharmacological treatment for SUDs and HIV infection while continuing to use/misuse licit or illicit substances.

The ultimate goal is to help identify and minimize the public health impact of these pharmacologic interactions and provide the safest treatments for patients with comorbid HIV and SUD.

Background

In the US, 1.2 million people are living with HIV with a third of this population concurrently using drugs or alcohol. Of all individuals with HIV, 24% are current drug users receiving antiretroviral therapy (ART) in the form of pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PoEP), either for the treatment of HIV infection or for the prevention of HIV Substance misuse is one the contributing factors in the spread of HIV. Despite the high prevalence of drug use among people in treatment with ART, little is known about the pharmacokinetic, pharmacodynamic, and potential toxicity of the concomitant use of ART and various misused substances and medications used in treatment for SUDs.

Research is therefore critically needed to elucidate clinically significant drug interactions and to design effective and safe pharmacotherapies that will prove effective, less-toxic, with an improvement in adherence and prevention of ART resistance, sustainable over long periods.

Research Objectives

NIDA is interested in applications focusing on drug-drug interactions among misused substances and medications to treat HIV infection and/or SUDs by evaluating their pharmacokinetic, pharmacodynamic, and toxicological effects.

This NOSI encourages, but is not limited to, research applications in the following areas

1. PK and PD properties of the combination of misused substances , medications to treat HIV infection, and pharmacotherapies to treat SUD, i.e., Buprenorphine, Methadone, Naltrexone, and Lofexidine).
2. PK and PD interactions to determine if they reduce the efficacy of medications used to treat HIV.
3. Adverse drug reactions in individuals taking ART who also use opioids (either prescription or non-prescription), heroin, fentanyl, MATs, stimulants, cannabinoids, synthetic drugs, and natural substances such as, kratom orpsilocybin.

Application and Submission Information

This notice applies to due dates on or after May 7, 2020 and subsequent receipt dates through May 8, 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.

• PA-19-056: NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
• PA-19-055: NIH Research Project Grant (Parent R01 Clinical Trial Required)
• PA-19-091: NIH Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required)
• PA-19-052: NIH Small Research Grant Program (Parent R03 Clinical Trial Not Allowed)
• PA-19-092: NIH Exploratory/Developmental Research Grant Program (Parent R21 Basic Experimental Studies with Humans Required)
• PA-19-053: NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)
• PA-19-054: NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)

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-20-013” (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 be not be considered for the NOSI initiative.

Please direct all inquiries to the contacts in Section VII of the listed funding opportunity announcements with the following additions/substitutions:

Scientific/Research Contact(s)

Guifang Lao, MD, PhD
National Institute on Drug Abuse (NIDA)
Telephone: 301-827-5831
Email: [email protected]