A Phase 2 interventional study of 12 weeks of weekly subcutaneous semaglutide injection in Methamphetamine Use Disorder, sponsored by Kirby Institute. Not yet recruiting at 5 sites in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by Kirby Institute · Phase 2, Interventional, and Treatment
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. We do not know if this will help people who use methamphetamine ('ice') to reduce their use. This study will treat people who use methamphetamine with weekly injections of semaglutide. It will provide data on if this is a potentially safe and practical treatment for this group of people.
Methamphetamine use disorder is a major public health concern in Australia and globally, associated with high morbidity and limited treatment options. People with methamphetamine use disorder frequently face social marginalisation, psychiatric comorbidity, housing instability, and criminal justice involvement, contributing to poor treatment access and outcomes. At present, no pharmacotherapies have been approved for the treatment of methamphetamine use disorder. While several agents have demonstrated preliminary promise-including mirtazapine, which has shown consistent findings across trials-none have yet established sufficient efficacy to achieve regulatory approval. 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. Preclinical studies show GLP-1 agonists reduce stimulant-related dopamine signalling and drug-seeking behaviour. Observational studies in humans suggest semaglutide may reduce risk of alcohol use disorder, hospitalisations related to substance use, and overdose, and a recent randomised controlled trial demonstrated reductions in cravings, and use of, alcohol and tobacco. However, no trials have yet evaluated semaglutide in methamphetamine use disorder. This pilot study will be the first to assess its feasibility, safety, and preliminary efficacy for methamphetamine use disorder.
2,238 studies on the registry are indexed under Substance-Related Disorders; 409 are open to participants now.
This study's planned enrollment of 40 is below the median of 108 across 1,840 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →Kirby Institute is the lead sponsor of 94 studies on the registry; 15 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
12 weeks of subcutaneous semaglutide administered once weekly
Drug: 12 weeks of weekly subcutaneous semaglutide injection
12 weeks of subcutaneous semaglutide administered once weekly, starting at 0.25 mg once weekly, titrated as tolerated up to 1.0 mg over the 12-week study period.
This study also gives Semaglutide. No intervention listed here names it: that was found by reading the record.
Efficacy Outcome (exploratory)
Last 4-week methamphetamine use measured by the TLFB method at week 12 compared to screening
Time frame: 12 weeks
Secondary exploratory outcome
Total number of days of self-reported methamphetamine use
Time frame: 12 weeks
Secondary exploratory outcome
End-of-treatment abstinence from methamphetamine (self-reported and oral fluid drug screens);
Time frame: 12 weeks
Secondary exploratory outcome
Use of, and end-of-treatment abstinence from, other substances (e.g., opioids, benzodiazepines, tobacco, alcohol).
Time frame: 12 weeks
Secondary exploratory outcome
Change in methamphetamine craving score on visual analogue scale
Time frame: 12 weeks
Secondary exploratory outcome
Weight loss
Time frame: 12 weeks
Secondary exploratory outcome
Retention in opioid agonist treatment (OAT) programs at 12 weeks (for those enrolled in OAT)
Time frame: 12 weeks
Secondary exploratory outcome
Change in health-related quality of life utility score on the EQ-5D-5L
Time frame: 12 weeks
Feasibility - recruitment
Recruitment: Number of participants screened, proportion enrolled, reasons for exclusion.
Time frame: Screening to week 14 end of study follow up visit
Feasibility - retention
Retention: Proportion completing the 12-week study; time-to-dropout; comparison of baseline characteristics of completers vs. non-completers.
Time frame: Screening to week 14 end of study follow up visit
Feasibility - adherence
Adherence to the intervention: Number and proportion of scheduled semaglutide doses received (in-clinic and self-administered).
Time frame: Baseline to week 12
Feasibility - data completeness
Data completeness: Proportion of participants with complete data at each timepoint for Timeline Follow Back (primary exploratory efficacy outcome), and quality of life
Time frame: Screening to week 14 end of study follow up visit
Feasibility - acceptance
Tolerability and perceived benefit: Proportion of participants who remain on semaglutide through week 12; rates of treatment discontinuation due to adverse events; and participant-reported perceptions of tolerability and benefit, captured using the Treatment Effectiveness Assessment (TEA) at week 12.
Time frame: Baseline to week 12
Safety - adverse events
Incidence, severity, and type of treatment-related adverse events and serious adverse events during the treatment period.
Time frame: 12 weeks
Safety - treatment-related serious adverse events
Proportion of participants experiencing at least one treatment-related serious adverse event or discontinuing treatment due to an adverse event related to the study medication.
Time frame: 12 weeks
Plan to share: No
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This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Semaglutide
Kirby Institute