Key Dates

Related Announcements

PA-20-183 - NIH Research Project Grant (Parent R01 Clinical Trial Required)

PA-20-185 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)

PA-20-184 – NIH Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required)

PA-20-200 - NIH Small Research Grant Program (Parent R03 Clinical Trial Not Allowed)?

Issued by

National Institute on Drug Abuse (NIDA)

Purpose

Background:

Variable responses to ART are due at least in part to human genetic variants that affect drug metabolism, drug disposition, and off-site drug targets. Defining effects of human genetic variants on HIV treatment toxicity, efficacy, and pharmacokinetics has far-reaching implications. Substances of abuse (opioid, stimulants, nicotine, anxiolytics, alcohol, etc.) and its treatments (methadone, buprenorphine, extended naltrexone, etc.) may interact with ART, altering its bioavailability, its safety, and its efficacy. It is known that nevirapine and efavirenz increase methadone clearance. New evidence demonstrates that variabilities in responses to ART depend in part on genetic variants for certain drugs of abuse and its therapies. For instance, a NR1I3 gene variant affected methadone clearance only in those taking efavirenz. Two other genetic variants in the ABCB1 and CYP2B6 genes decreased methadone clearance. More research, though, is necessary to better understand the role of pharmacogenomics in people with HIV (PLWH) with substance use disorders (SUD).

Research Areas

NIDA is interested in receiving research proposals focusing on studying pharmacogenomics in PLWH with SUD as a crucial step in the science of Precision Medicine, in the path of personalized care for HIV and drug abuse.. 

Topics include but are not limited to: 

• Correlation of genomics with ART, drugs of abuse and its treatments with absorption, distribution, metabolism, and elimination (ADME)
• Population differences in genotypic frequencies 
• Multiple genetic variants and its consequences 
• Clinical phenotypes and its pharmacogenomic correlations
• Genomic-wide association studies (GWAS) 
• Medical consequences of pharmacogenomic interactions with SUD-safety and efficacy
• Phenotypic and genomic at-risk populations; twin studies 
• Geographical correlations (rural, islands, international); areas of wide (e.g., Africa) vs limited (e.g., Iceland) genetic diversity 
• Informatics 
• Study design and methodology (e.g., prospective targeted vs observational), cost-effectiveness

Application and Submission Information

This notice applies to due dates on or after June 5, 2023 and subsequent receipt dates through May 8, 2026. 

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

• PA-20-183 - NIH Research Project Grant (Parent R01 Clinical Trial Required)
• PA-20-185 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
• PA-20-184 – NIH Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required)
• PA-20-200 - NIH Small Research Grant Program (Parent R03 Clinical Trial Not Allowed)

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-24-001” (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

Scientific/Research Contact(s)

Guifang Lao, Ph.D.
National Institute on Drug Abuse/Division of Therapeutics and Medical Consequences
Telephone: 301-827-5931
Email: laog@nih.gov