Semaglutide for Helping Opioid Recovery

What Was Tested

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

The is a pilot, 12-week, double-blind, placebo-controlled, randomized trial of individuals with opioid use disorder (OUD) newly initiating buprenorphine to receive either weekly injections of semaglutide (n=23) or matching placebo (n=23).

The primary aim is to determine the effects of semaglutide on cue-reactivity among individuals with OUD.

It had two arms (groups): Semaglutide (experimental) and Placebo (placebo comparator).

This arm will receive saline placebo (n=23).

The registry classes the interventions as drug and other.

More on the Plan

Potential participants will be screened and enrolled only if they meet full inclusion criteria.

After baseline procedures are complete, participants will be randomized to semaglutide or placebo.

Following randomization, participants will be scheduled for thirteen weekly study visits.

Each visit will last approximately 1 hour, except for study visits 1 (baseline), 7, and 14 (follow-up) which will take no more than 3 hours in order to conduct reward- and stress-related neurocognitive testing.

Who Took Part

The registry lists 46 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: English-speaking adults aged 18 or older. DSM-5 diagnosis of severe opioid use disorder (OUD). Planning to continue buprenorphine or methadone treatment throughout the study. Willing to authorize communication between the study team and their MOUD prescriber via a 42 CFR release.

The full record lists 6 inclusion and 14 exclusion criteria; among the exclusions: active psychosis, suicidality, homicidality, or psychiatric conditions impairing capacity to consent; current or lifetime history of an eating disorder; BMI \<21 kg/m².

How the Study Was Run

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

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2025-06-02 with completion listed for 2027-09-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Cue-induced Cravings for Opioids (time frame: Baseline, 6 weeks, and 13 weeks after baseline visit). Relapse to Illicit Opioid Use (time frame: Weekly from baseline to end of study at 14 weeks).

It also tracked 19 secondary outcomes, for example Visual Probe Task, Iowa Gambling Task (IGT), Monetary Choice Questionnaire (MCQ), Clinical Opiate Withdrawal Scale (COWS), Patient Health Questionnaire (PHQ8) and Generalized Anxiety Disorder (GAD7).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 46 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.