NCT04199728

Use of a GLP-1R Agonist to Treat Opioid Use Disorder

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This research is being done to find out if liraglutide (brand name is Saxenda®) can safely and effectively reduce craving for opioids in patients with opioid use disorder, a primary factor contributing to early relapse.

Detailed description

The rationale for the proposed research is to develop an acute intervention that can improve treatment outcomes in opioid use disorder (OUD) by reducing craving, a primary factor contributing to early relapse. Although liraglutide was approved for human use in 2010, there are no data testing the effectiveness in patients with an OUD. The objective of the proposed research is to test whether treatment with a GLP-1R agonist can reduce craving in humans with OUD. Understanding how a 'satiety' agent may affect craving and brain responses to drug cues in an OUD population would provide entirely novel information. If liraglutide shows a trend towards efficacy, and safety of the GLP-1R agonist is demonstrated in this population, it would provide an indication to run the second phase, multi-center clinical trial of GLP-1R agonist in OUD patients.

Conditions

• Opiate Substitution Treatment
• Opioid-Related Disorders

Interventions

Type	Name	Description
DRUG	Liraglutide Pen Injector	Liraglutide will be provided using an injection pen provided by the manufacturer
DRUG	Placebo	Placebo injection pen

Timeline

• Start date: 2021-10-18
• Primary completion: 2023-09-13
• Completion: 2023-09-13
• First posted: 2019-12-16
• Last updated: 2024-11-06
• Results posted: 2024-11-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study