12 weeks of weekly subcutaneous semaglutide injection
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.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Has provided voluntary, written informed consent;
2. Aged 18 years or older;
3. Diagnosed with moderate to severe methamphetamine use disorder (DSM-5 criteria);
4. Self-reported methamphetamine use on at least 14 of past 28 days and a positive oral fluid drug screen for amphetamine/methamphetamine;
5. Willing and able to comply with study procedures and follow-up visits;
6. People of child-bearing potential must agree to use effective contraception during treatment and during the 60 days after treatment end.
Exclusion Criteria:
1. Uncontrolled medical or psychiatric conditions that may interfere with participation;
2. Body mass index less than 22 kg/m2;
3. Confirmed diagnosis of diabetes mellitus (either known history of diabetes; concomitant treatment with insulin, metformin, sulfonylureas, thiazolidinediones, SGLT2 inhibitor, DPP4 inhibitor; or HbA1c \>6.5 at screening);
4. Currently taking a GLP-1 receptor agonist;
5. Known hypersensitivity or contraindications to GLP-1 receptor agonists as per product information;
6. Current enrolment in another interventional trial;
7. Lactating, pregnant or at risk of pregnancy not willing to avoid pregnancy
8. History of pancreatitis;
9. History of medullary thyroid cancer;
10. Current admission to a residential rehabilitation program or inpatient program or planned admission during the study period, which would interfere with participation in study visits or procedures;
11. Currently experiencing psychosis or current active suicidality
12. Any condition or circumstance that, in the opinion of the investigator, would compromise the participant's ability to comply with the study procedures, complete protocol requirements, or provide reliable data.
Primary outcome measure(s)
Efficacy Outcome (exploratory) — 12 weeks Last 4-week methamphetamine use measured by the TLFB method at week 12 compared to screening
Trial sites (5)
Facility
City
Region
Status
Kirketon Road Centre
Darlinghurst
New South Wales
Rankin Court Treatment Centre, St Vincent's Hospital Sydney
Darlinghurst
New South Wales
Alcohol & Drug Service, Metro Health North Brisbane
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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