GLP-1R Agonist Treatment for Opioid Use Disorder

What Was Tested

In this phase 2 trial, researchers set out to test Semaglutide.

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

Participants in the control group will have placebo administered once per week.

The registry classes the interventions as drug.

More on the Plan

Following successful consent and initiation of screening, participants will complete a baseline evaluation and begin a baseline data collection period.

If screened into the study, they will be randomly assigned to semaglutide or placebo control arms, in a 1:1 ratio using a permuted-block randomization algorithm stratified by site and MOUD, and begin a 1-week baseline period.

Participants will receive study intervention in an outpatient setting for a total of 12 weeks.

After the 12-week intervention, participants will discontinue semaglutide or placebo and be observed for an additional week (wash-out period).

Who Took Part

The registry lists 200 planned participants were the target.

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. Body mass index (BMI) \> 18. Able and willing to provide informed consent prior to any study-related activities. Have at least 1 urine test positive for opioids after 2 weeks on BUP or 4 weeks on methadone. Have positive self-reporting of opioid use after 2 weeks on BUP or 4 weeks on methadone.

The full record lists 11 inclusion and 24 exclusion criteria; among the exclusions: age \< 18 or \> 75 years; BMI \<18; individuals who are pregnant, planning pregnancy, breastfeeding, or unwilling to use adequate contraceptive measures.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Semaglutide 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 2025-01-27 with completion listed for 2027-04-30.

It ran at 4 sites in United States (4).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of participants being abstinent from illicit and nonprescribed opioids (time frame: Study week 2). Number of participants being abstinent from illicit and nonprescribed opioids (time frame: Study week 3). Number of participants being abstinent from illicit and nonprescribed opioids (time frame: Study week 4).

It also tracked 51 secondary outcomes, for example Self-reported opioid craving scores as assessed via smartphone surveys, Self-reported opioid craving scores as assessed via smartphone surveys, Self-reported opioid craving scores as assessed via smartphone surveys, Self-reported opioid craving scores as assessed via smartphone surveys, Self-reported opioid craving scores as assessed via smartphone surveys and Self-reported opioid craving scores as assessed via smartphone surveys.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 200 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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