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

ConditionMethamphetamine Use Disorder
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorKirby Institute

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Adults with methamphetamine use disorderExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Efficacy Outcome (exploratory)

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

Time frame
12 weeks

Secondary outcomes

1

Secondary exploratory outcome

Total number of days of self-reported methamphetamine use

Time frame
12 weeks
2

Secondary exploratory outcome

End-of-treatment abstinence from methamphetamine (self-reported and oral fluid drug screens);

Time frame
12 weeks
3

Secondary exploratory outcome

Use of, and end-of-treatment abstinence from, other substances (e.g., opioids, benzodiazepines, tobacco, alcohol).

Time frame
12 weeks
4

Secondary exploratory outcome

Change in methamphetamine craving score on visual analogue scale

Time frame
12 weeks

Other outcomes

1

Feasibility - recruitment

Recruitment: Number of participants screened, proportion enrolled, reasons for exclusion.

Time frame
Screening to week 14 end of study follow up visit
2

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
3

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
4

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kirby Institute

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: