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Semaglutide for Treatment of People With Methamphetamine Use Disorder: the SHIFT Study

Plain-language guide to NCT07509112: phase 2 interventional trial of Semaglutide, 40 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT07509112
Phase
phase 2
Status
not yet recruiting
Start
2026-09
Completion (planned or actual)
2027-01
Participants
40 (estimated)
Design
na, open label (everyone knows who gets what), treatment
Conditions studied
Methamphetamine Use Disorder
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

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

Methamphetamine use disorder is a major public health concern in Australia and globally.

GLP-1 medications such as semaglutide (e.g.

Ozempic) are approved for diabetes and medication, and may potentially affect craving for other substances apart from food.

It had 1 arm (groups): Adults with methamphetamine use disorder (experimental).

12 weeks of subcutaneous semaglutide administered once weekly.

The registry classes the interventions as drug.

More on the Plan

People with methamphetamine use disorder frequently face social marginalisation, psychiatric comorbidity, housing instability, and criminal justice involvement, contributing to poor treatment access and outcomes.

Ongoing registrational trials, such as those evaluating extended-release naltrexone combined with bupropion, and mirtazapine, may clarify the potential role of these agents in clinical practice.

Glucagon-like peptide-1 (GLP-1) receptor agonists, including semaglutide, are approved for diabetes and obesity and have central effects on reward pathways relevant to addiction.

However, no trials have yet evaluated semaglutide in methamphetamine use disorder.

Who Took Part

40 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: Has provided voluntary, written informed consent;. Aged 18 years or older;. Diagnosed with moderate to severe methamphetamine use disorder (DSM-5 criteria);. Self-reported methamphetamine use on at least 14 of past 28 days and a positive oral fluid drug screen for amphetamine/methamphetamine;. Willing and able to comply with study procedures and follow-up visits;.

The full record lists 6 inclusion and 12 exclusion criteria; among the exclusions: uncontrolled medical or psychiatric conditions that may interfere with participation;; body mass index less than 22 kg/m2;; currently taking a glp-1 receptor agonist;.

How the Study Was Run

The set-up was single-group and open-label.

Everyone knew when Semaglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2026-09 with completion listed for 2027-01.

It ran at 5 sites in Australia (5).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 7 secondary outcomes, for example Secondary exploratory outcome, Secondary exploratory outcome, Secondary exploratory outcome, Secondary exploratory outcome, Secondary exploratory outcome and Secondary exploratory outcome.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Semaglutide in 40 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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

Our Notes on the Compound

Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.