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

NCT07509112 | Not Yet Recruiting Phase 2

• 1 other identifier: VHCRP2502
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 5

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 injections of semaglutide. It will provide data on if this is a potentially safe and practical treatment for this group of people.

Conditions

Methamphetamine Use Disorder

Keywords

Substance use disorder; Addiction; Drug use; Methamphetamine; Stimulants; GLP-1; Semaglutide; Ozempic; Wegovy

Outcome Measures

Primary Outcomes (1)

• Efficacy Outcome (exploratory)

  Last 4-week methamphetamine use measured by the TLFB method at week 12 compared to screening

  12 weeks

Secondary Outcomes (7)

• Secondary exploratory outcome

  12 weeks

• Secondary exploratory outcome

  12 weeks

• Secondary exploratory outcome

  12 weeks

• Secondary exploratory outcome

  12 weeks

• Secondary exploratory outcome

  12 weeks

Other Outcomes (7)

• Feasibility - recruitment

  Screening to week 14 end of study follow up visit

• Feasibility - retention

  Screening to week 14 end of study follow up visit

• Feasibility - adherence

  Baseline to week 12

Study Arms (1)

Adults with methamphetamine use disorder

EXPERIMENTAL

12 weeks of subcutaneous semaglutide administered once weekly

Drug: 12 weeks of weekly subcutaneous semaglutide injection

Interventions

12 weeks of weekly subcutaneous semaglutide injection DRUG

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.

Adults with methamphetamine use disorder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• People of child-bearing potential must agree to use effective contraception during treatment and during the 60 days after treatment end.

You may not qualify if:

• Uncontrolled medical or psychiatric conditions that may interfere with participation;
• Body mass index less than 22 kg/m2;
• 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);
• Currently taking a GLP-1 receptor agonist;
• Known hypersensitivity or contraindications to GLP-1 receptor agonists as per product information;
• Current enrolment in another interventional trial;
• Lactating, pregnant or at risk of pregnancy not willing to avoid pregnancy
• History of pancreatitis;
• History of medullary thyroid cancer;
• 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;
• Currently experiencing psychosis or current active suicidality
• 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.

Sponsors & Collaborators

• Kirby Institute: lead

Study Sites (5)

Kirketon Road Centre

Darlinghurst, New South Wales, 2010, Australia

Location

Rankin Court Treatment Centre, St Vincent's Hospital Sydney

Darlinghurst, New South Wales, 2010, Australia

Location

Alcohol & Drug Service, Metro Health North Brisbane

Brisbane, Queensland, 4000, Australia

Location

Drug and Alcohol Services, South Australia

Morphett Vale, South Australia, 5162, Australia

Location

Next Step Drug and Alcohol Services

East Perth, Western Australia, 6004, Australia

Location

MeSH Terms

Conditions

Substance-Related Disorders; Behavior, Addictive

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Central Study Contacts

David Goodman-Meza, MD, PhD

CONTACT

+61 2 9385 0900; shiftstudy@unsw.edu.au

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: April 3, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (5)