162 Participants NeededMy employer runs this trial

Semaglutide for Methamphetamine Addiction

(GEM Trial)

XL
PO
Overseen ByPhillip O Coffin, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: San Francisco Department of Public Health
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a medication called semaglutide (Wegovy) to assist individuals struggling with methamphetamine addiction. Researchers aim to determine if this medication can reduce meth use and assess its safety and acceptance among participants. The trial consists of two parts: an initial study with 25 participants all taking semaglutide, followed by a larger study where participants are randomly assigned to either semaglutide or a placebo (a pill with no active drug). Suitable candidates have used meth frequently in the past month and wish to quit or reduce their use. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

You may need to stop taking certain medications before joining the trial. Specifically, if you've used medications for weight management or certain diabetes medications in the past 30 days, you might not be eligible. It's best to discuss your current medications with the study team to see if they affect your eligibility.

Is there any evidence suggesting that semaglutide is likely to be safe for humans?

Research has shown that semaglutide, the treatment being tested for methamphetamine addiction, has been studied for its safety and potential benefits. Some studies suggest it might help reduce hospital visits related to substance use and lower the risk of overdose. Semaglutide, a GLP-1 receptor agonist, has been linked to a 14% lower risk of developing any substance use disorder.

Regarding safety, research indicates that semaglutide is generally well-tolerated. Although there is a moderate interaction between semaglutide and methamphetamine, trial researchers will closely monitor this. Overall, evidence suggests that semaglutide is safe to use, but like all medications, it is important to watch for any possible side effects.12345

Why do researchers think this study treatment might be promising for methamphetamine addiction?

Unlike the standard treatments for methamphetamine addiction, which typically involve behavioral therapies and supportive medications like antidepressants, semaglutide is unique because it is traditionally used for managing type 2 diabetes and obesity. This drug works by mimicking a hormone called GLP-1 that regulates appetite and insulin levels, which might help reduce cravings and addictive behaviors associated with methamphetamine use. Researchers are excited about semaglutide because it offers a novel approach by potentially addressing the biological aspects of addiction, which current therapies do not directly target.

What evidence suggests that semaglutide might be an effective treatment for methamphetamine addiction?

Research has shown that semaglutide, also known as Wegovy, might help treat methamphetamine use disorder (MeUD). In this trial, participants will receive either semaglutide or a placebo. Studies have found that medications like semaglutide can lower substance use and its harmful effects. Specifically, semaglutide has been linked to a reduced risk of developing substance use disorders. Additionally, similar drugs have shown potential in reducing methamphetamine use. These findings suggest that semaglutide could help decrease methamphetamine addiction by influencing brain pathways involved in addiction.12345

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 who have moderate to severe methamphetamine addiction, use meth at least half the month, test positive for meth in urine, want to cut down or quit, have a BMI of 25 or higher, and can follow study rules. Women must use reliable birth control if they could become pregnant.

Inclusion Criteria

I have been diagnosed with a moderate to severe methamphetamine use disorder.
My BMI is 25 or higher.
I have at least 1 centimeter of hair on my scalp.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pilot Treatment

Participants receive Wegovy over a 12-week treatment period

12 weeks

Pilot Follow-up

Participants have a follow-up visit to evaluate feasibility, acceptability, and preliminary efficacy of Wegovy

8 weeks
1 visit at week 20

Phase IIb Treatment

Randomized-controlled trial with Wegovy or placebo to determine efficacy in treating MeUD

12 weeks

Phase IIb Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Semaglutide

Trial Overview

The study tests whether semaglutide (Wegovy), compared to a placebo (inactive treatment), helps people with methamphetamine addiction reduce or stop their use. The trial has two phases: an initial small open-label phase and then a larger randomized controlled phase where participants are assigned by chance to Wegovy or placebo.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Semaglutide (Wegovy)Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

San Francisco Department of Public Health

Lead Sponsor

Trials
38
Recruited
36,000+

Citations

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NCT07204249 | Glutide for Ending Methamphetamine

GEM is a two-phase study to evaluate the use of semaglutide (Wegovy) for the treatment of methamphetamine use disorder (MeUD).

GLP-1 medications get at the heart of addiction: study

A study by WashU Medicine researchers finds GLP-1 use is associated with seven fewer new cases of substance use disorder and 12 fewer harmful ...

Study Details | NCT07509112 | Semaglutide for Treatment ...

Observational studies in humans suggest semaglutide may reduce risk of alcohol use disorder, hospitalisations related to substance use, and overdose, and a ...

Glucagon-like peptide 1 receptor agonists in substance ...

Current treatments have limited efficacy and there are no United States Food and Drug Administration (FDA)-approved treatments for several SUDs (such as ...