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Semaglutide for Treatment of People With Methamphetamine Use Disorder: the SHIFT Study Phase 2 40

Not yet recruiting
Clinical Trial NCT07509112 (SHIFT) is designed to study Treatment for Methamphetamine Use Disorder. This Phase 2 interventional study is not yet recruiting. Enrollment is planned to begin on May 1, 2026 until the study accrues 40 participants. Led by Kirby Institute, this study is expected to complete by March 1, 2027. The latest data from ClinicalTrials.gov was last updated on April 3, 2026.
Brief 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 injec...Show More
Detailed Description
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 ...Show More
Official Title

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

Conditions
Methamphetamine Use Disorder
Other Study IDs
  • SHIFT
  • VHCRP2502
NCT ID Number
NCT07509112
Start Date (Actual)
2026-05
Last Update Posted
2026-04-03
Completion Date (Estimated)
2027-03
Enrollment (Estimated)
40
Study Type
Interventional
PHASE
Phase 2
Status
Not yet recruiting
Keywords
Substance use disorder
Addiction
Drug use
Methamphetamine
Stimulants
GLP-1
Semaglutide
Ozempic
Wegovy
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalAdults with methamphetamine use disorder
12 weeks of subcutaneous semaglutide administered once weekly
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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Efficacy Outcome (exploratory)
Last 4-week methamphetamine use measured by the TLFB method at week 12 compared to screening
12 weeks
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Secondary exploratory outcome
Total number of days of self-reported methamphetamine use
12 weeks
Secondary exploratory outcome
End-of-treatment abstinence from methamphetamine (self-reported and oral fluid drug screens);
12 weeks
Secondary exploratory outcome
Use of, and end-of-treatment abstinence from, other substances (e.g., opioids, benzodiazepines, tobacco, alcohol).
12 weeks
Secondary exploratory outcome
Change in methamphetamine craving score on visual analogue scale
12 weeks
Secondary exploratory outcome
Weight loss
12 weeks
Secondary exploratory outcome
Retention in opioid agonist treatment (OAT) programs at 12 weeks (for those enrolled in OAT)
12 weeks
Secondary exploratory outcome
Change in health-related quality of life utility score on the EQ-5D-5L
12 weeks
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  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.

  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.
Kirby Institute logoKirby Institute
Study Central Contact
Contact: David Goodman-Meza, MD, PhD, +61-403-995-056, [email protected]
5 Study Locations in 1 Countries

New South Wales

Kirketon Road Centre, Darlinghurst, New South Wales, 2010, Australia
Phillip Read, Contact, +61 2 9360 2766, [email protected]
Phillip Read, Principal Investigator
Rankin Court Treatment Centre, St Vincent's Hospital Sydney, Darlinghurst, New South Wales, 2010, Australia
David Goodman-Meza, MD, PhD, Contact, [email protected]
David Goodman-Meza, Principal Investigator

Queensland

Alcohol & Drug Service, Metro Health North Brisbane, Brisbane, Queensland, 4000, Australia
Mark Daglish, Contact, +617 3837 5764, [email protected]
Mark Daglish, Principal Investigator

South Australia

Drug and Alcohol Services, South Australia, Morphett Vale, South Australia, 5162, Australia
Katherine Senior, Contact, +618 8325 8111, [email protected]
Katherine Senior, Principal Investigator

Western Australia

Next Step Drug and Alcohol Services, East Perth, Western Australia, 6004, Australia
Michael Christmass, Contact, +6189430 5966, [email protected]
Michael Christmass, Principal Investigator