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

What Was Tested

This registered phase 1, phase 2 trial tested Liraglutide.

It had two arms (groups): Investigational group (experimental) and Control group (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Understanding how a 'satiety' agent may affect craving and brain responses to drug cues in an OUD population would provide entirely novel information.

Who Took Part

27 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age 18 to 75 years. Able and willing to provide informed consent prior to any study-related activities. Must be able to read and communicate in English sufficiently to complete all study requirements, including Ecology Momentary Assessment (EMA).

The full record lists 5 inclusion and 17 exclusion criteria; among the exclusions: age \< 18 or \> 75 years; women who are pregnant, planning pregnancy, breastfeeding, or unwilling to use adequate contraceptive measures; history of angioedema, serious hypersensitivity reaction, or anaphylactic reaction to liraglutide or another glucagon-like peptide-1 receptor (glp1r) agonist.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.

The Liraglutide group and the comparison group ran side by side rather than switching.

As a double-blind Liraglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2021-10-18 with completion listed for 2023-09-13.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Self-reported Cue-elicited Drug Craving as Measured by Visual Analog Scale (VAS). Change in Ambient Drug Craving Over Time as Measured by Visual Analog Scale (VAS) (time frame: Baseline (Day 1), Treatment Days (Days 2-19)).

It also tracked 8 secondary outcomes, for example Change in Blood Pressure, Change in Heart Rate, Change in Respiratory Rate, Absolute Change in Body Weight, Percent Change in Body Weight and Change in Fasting Blood Samples for Fructosamine.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Liraglutide in 27 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Liraglutide compound page, all human trials.