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GLP-1 receptor agonists for the prevention and treatment of opioid use disorder

Award Number: R01DA065510
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/15/2026
PERIOD OF PERFORMANCE END DATE: 07/31/2031

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GLP-1 receptor agonists for the prevention and treatment of opioid use disorder - PROJECT SUMMARY Glucagon-like peptide-1 receptor agonist-based agents (GLP-1RAs), which are indicated for treatment of type 2 diabetes (T2D), obesity, and comorbid cardiovascular disease, have been proposed as potentially effective medications for the prevention and treatment of opioid use disorder (OUD). However, only one clinical trial in individuals with OUD has been completed, with a single participant in the GLP-1RA arm finishing the study. Three clinical trials are currently underway, but remain preliminary due to restrictive entry criteria, small sample sizes, and short durations, limiting their ability to inform long-term outcomes in U.S. populations. Furthermore, previous observational studies evaluating GLP-1RAs for OUD have relied on electronic health record data, which are often prone to measurement error and missingness. These limitations have sparked interest in using causal inference methods with real-world data to evaluate whether GLP-1RAs could be effective in preventing and treating OUD in real-world clinical practice. We will use claims data and linked electronic health record and laboratory result data from Optum Labs® Data Warehouse (OLDW), which includes health insurance claims for all Medicare fee-for-service enrollees and for commercial and Medicare Advantage enrollees across the U.S., to generate evidence relevant to the use of GLP-1RAs in clinical practice. We have identified 9286 patients with OUD in OLDW who were prescribed GLP-1RAs from 2016-2024. In Aim 1, we will adopt the target trial framework, which utilizes counterfactual theory to design analyses comparing the effects of sustained treatment strategies, to compare the risk of developing OUD among patients with T2D initiating treatment with GLP-1RAs versus commonly prescribed second-line medications for T2D (sodium-glucose cotransporter-2 inhibitors [SGLT2is] or dipeptidyl peptidase-4 inhibitors [DPP4is]). This analysis is necessary to evaluate the benefits of GLP-1RAs for the prevention of OUD in real-world populations. Combination pharmacotherapy is increasingly recognized as a promising strategy for treating OUD, and FDA guidance recommends that evaluations of new relapse-targeting medications focus on patients who are already stable on existing medications for OUD (MOUD). Therefore, in Aim 2, we will adopt the target trial framework to evaluate the comparative effectiveness and safety of GLP-1RAs versus SGLT2is or DPP4is among patients with OUD and comorbid T2D who are receiving methadone in an opioid treatment program, buprenorphine, or naltrexone. In Aims 1 and 2, we will integrate novel machine learning methods to identify phenotypes of patients more likely to experience beneficial or harmful outcomes with GLP-1RAs. In Aim 3, we will conduct a series of within-subject comparison studies to compare the risk of opioid-related emergency department visits and hospitalizations in patients before and after receiving GLP-1RAs, which will help control for unmeasured confounding from time-invariant characteristics. Overall, these aims align with NIDA’s strategic priorities to identify existing medications for OUD treatment.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $830,097 )
2026	2026	MAYO CLINIC	200 1ST ST SW	ROCHESTER	MN	55905	OLMSTED	USA	Drug Use and Addiction Research Programs	000	1	9/10/2026	NEW	$830,097
														Subtotal = $830,097

Grand Total All Awards = $830,097

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GLP-1 receptor agonists for the prevention and treatment of opioid use disorder

Award Number: R01DA065510

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/15/2026

PERIOD OF PERFORMANCE END DATE: 07/31/2031

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