Actively Recruiting
Glutide for Ending Methamphetamine Treatment of Methamphetamine Use Disorder with Semaglutide
Led by San Francisco Department of Public Health · Updated on 2026-06-03
162
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of semaglutide (Wegovy) to treat methamphetamine use disorder (MeUD) in a two-phase study called GEM. The first phase is a pilot study with 25 participants receiving open-label Wegovy for 12 weeks, followed by a follow-up visit at week 20 to assess feasibility, acceptability, and early effects. The second phase is a phase IIb randomized controlled trial enrolling 162 participants who will be randomly assigned to receive either Wegovy or a placebo, with group assignments blinded. In the pilot phase, all participants receive Wegovy over 12 weeks with one follow-up at week 20. The randomized trial phase compares Wegovy to placebo to evaluate its effect on MeUD. Participants receive injections of the study drug or placebo, and researchers monitor methamphetamine use and other health measures during the treatment period. The trial includes two study sites and uses double-blind methods to ensure unbiased results. Participants will be involved in regular study visits for drug administration, health assessments, and urine testing to confirm methamphetamine use status. Researchers will collect data on methamphetamine use reduction, the ratio of eligible to enrolled participants, adherence to injections, and discontinuation rates over 12 to 20 weeks. Safety monitoring and follow-up visits will ensure participant well-being throughout the study, which may last up to 20 months for some measures.
CONDITIONS
Brief Title
Glutide for Ending Methamphetamine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to provide informed consent and comply with study procedures
- Age between 18 and 65 years inclusive
- Moderate to severe Methamphetamine Use Disorder by clinical interview
- Self-reported methamphetamine use at least 15 days in the past 30
- Methamphetamine-positive urine during screening and run-in period
- Interest in stopping or reducing methamphetamine use
- Body mass index (BMI) of 25 kg/m2 or higher
- At least 1 centimeter of scalp hair
- If of child-bearing potential, agreement to use effective contraception or have sterile partner
- Able to provide names of at least 2 persons who can consistently locate participant
You will not qualify if you...
- Uncontrolled hypertension with systolic BP above 160 mmHg or diastolic BP above 90 mmHg
- Diabetes or history of diabetic ketoacidosis
- History or current hypoglycemia
- History of malignant neoplasms within past 5 years except certain skin cancers
- History of heart failure or severe gastrointestinal disease
- Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia 2A or 2B
- Impaired kidney function
- Elevated liver enzymes or other specified lab abnormalities
- Calcitonin value equal or above 50 ng/L
- History of retinopathy
- Women who are pregnant, lactating, or not using accepted contraception
- Acute or chronic illnesses likely to cause hospitalization or death during trial
- Plan to have all hair removed or chemically treated during study
- Moderate to severe opioid, cocaine, or alcohol use disorder
- Current non-drug-induced psychotic disorder
- History of suicide attempt or recent suicidal thoughts
- Psychiatric illness precluding safe study completion
- Uncontrolled thyroid disease
- Recent use of certain diabetes or weight management medications
- Prior use or allergy to GLP-1 agonists
- Medications that may compromise safety or treatment
- Enrollment in other addiction treatments or studies affecting safety or data
- Plans to leave study area during trial
- Scheduled surgery requiring general anesthesia
- Inability to communicate fluently in English
- Any condition interfering with safe participation or adherence
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants receive Semaglutide or placebo as part of the study treatment to reduce methamphetamine use.
Trial Site Locations
Total: 1 location
1
Center on Substance Use and Health
San Francisco, California, United States, 94102
Actively Recruiting
Research Team
P
Phillip O Coffin, MD
X
Xochitl Luna Marti, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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