Methamphetamine-dependencePhase 2GEMNCT07204249
Glutide for Ending Methamphetamine
A Phase 2 study testing Semaglutide in people with Methamphetamine-dependence, run by San Francisco Department of Public Health at 1 site in United States.
Trial summary
GEM is a two-phase study to evaluate the use of semaglutide (Wegovy) for the treatment of methamphetamine use disorder (MeUD). The first phase is a pilot study, which will be an open-label, single-arm pilot study of 25 participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Methamphetamine-dependence
- What is being tested?
- Semaglutide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2026to 15 Feb 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Ability to provide informed consent before any study-related activity, willing to comply with all study procedures, and be available for the duration of the study,
- Age 18 - 65 years inclusive,
- Moderate to severe Methamphetamine Use Disorder by Structured Clinical Interview for DSM Disorders (SCID),
- Self-reported methamphetamine use ≥15 days out of the past 30,
- Methamphetamine-positive urine during screening and run-in period,
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- Interested in stopping or reducing meth use,
- BMI ≥ 25kg/m2,
- Have at least 1 centimeter of scalp hair,
- Agree (if the participant is of child-bearing potential) to use effective contraceptive methods, unless all of the participant's male partner(s) is/are surgically sterile (underwent vasectomy). Acceptable contraceptives include oral contraceptives, contraceptive sponge, patch, double barrier (diaphragm/spermicidal or condom/spermicidal), intrauterine contraceptive system, etonogestrel implant, medroxyprogesterone acetate contraceptive injection, complete abstinence from sexual intercourse, and/or hormonal vaginal ring. Contraceptive measures sold for emergency use after unprotected sex are not acceptable methods for routine use. Women of child-bearing potential must provide negative urine pregnancy test prior to randomization.
- Note: A woman is considered fertile (of childbearing potential) following menarche and until becoming postmenopausal unless permanently sterile. Women in the following categories are not considered of childbearing potential: premenarcheal, premenopausal female with one of the following: documented hysterectomy, documented bilateral salpingectomy, documented bilateral oophorectomy. Postmenopausal female is defined as no menses for 12 months without an alternative medical cause. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the non-hormonal highly effective contraception methods if they wish to continue their HRT during the trial.
- Be able to provide the names of at least 2 persons who can consistently locate their whereabouts.
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- Uncontrolled hypertension or systolic BP >160 mmHg and/or diastolic BP >90 mmHg, averaged from three measurements,
- Diabetes (type 1 or 2), hemoglobin A1c ≥ 6.5 at screening, or history of diabetic ketoacidosis,
- History or current hypoglycemia (blood glucose <70 mg/dL),
- History of malignant neoplasms within the past 5 years prior to screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed.
- History of heart failure or severe gastrointestinal disease (including acute or chronic pancreatitis, any gastric emptying disorder, gallbladder disease; any gastric resection),
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- Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia 2A or 2B,
- Impaired renal function (estimated GFR <60 ml/min),
- Lipase, amylase, direct (conjugated) bilirubin, or alkaline phosphatase (ALP) 1.5 times the upper limit of normal, or ALT or AST more than 2.5 times the upper limit of normal,
- Calcitonin value equal to or above 50 ng/L,
- History of retinopathy,
- Women who are currently pregnant, or plan to become pregnant, or lactating, or of childbearing potential and are not using medically accepted forms of contraception (see inclusion criterion 9 regarding medically accepted forms of contraception).
- Acute or chronic illnesses likely to result in hospitalization or death during trial participation,
- Plan to have all hair removed or chemically treat hair during study,
- Psychiatric/Substance Use Exclusions:
- Moderate to severe opioid, cocaine, or alcohol use disorder,
- Current non-drug-induced psychotic disorder by Structured Clinical Interview for DSM Disorders (SCID),
- History of a suicide attempt or past 30-day suicidal ideation,
- Have any psychiatric illness or condition which in the opinion of the PI and/or the Study Physician would preclude safe and/or successful completion of the study,
- Weight-related exclusions:
- 1. Uncontrolled thyroid disease,
- Medication-related exclusions:
- Past 30 day use of sulfonylureas, insulin and insulin products, or medication used for weight management (e.g., orlistat, naltrexone-bupropion, liraglutide, semaglutide, tirzepatide, phentermine, topiramate, benzhetamine, diethylpropion, phendimetrazine).
- Prior use of or known hypersensitivity to any GLP-1 agonist,
- Any otherwise not specified concomitant medication that could compromise participant safety or treatment in the opinion of the Study Physician and/or the PIs,
- General exclusions:
- Current, anticipated, or pending enrollment in another addiction treatment program and/or research study that could potentially affect participant safety and/or the study data/design as determined by the Principal Investigator and/or Study Physician.
- Planning to leave the area during the trial,
- Surgery scheduled during the trial, except for minor surgical procedures that, in the opinion of the PI and/or the Study Physician, will not require general anesthesia with the risk of aspiration,
- Unable to communicate (read, write, and speak) fluently in English, OR
- Any other condition that, in the PI's judgment, interferes with safe study participation or adherence to study procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Center on Substance Use and Health
San Francisco, California, 94102
Xochitl Luna Marti, MPH, 6282176235, xochitl.lunamarti@sfdph.org
About this study
GEM is a two-phase study to evaluate the use of semaglutide (Wegovy) for the treatment of methamphetamine use disorder (MeUD).
The first phase is a pilot study, which will be an open-label, single-arm pilot study of 25 participants. Participants will receive Wegovy over a 12-week treatment period, with a subsequent follow-up visit at week 20. This phase will evaluate the feasibility, acceptability, and preliminary efficacy of Wegovy for MeUD.
The second phase will be a phase IIb randomized-controlled trial to determine the efficacy of Wegovy in treating MeUD. This trial will be similar to the pilot with randomization to Wegovy or placebo and blinding of group assignment. The trial will enroll 162 participants across two sites.
- Conditions
- Methamphetamine-dependence
- Being tested
- Semaglutide, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
Semaglutide
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide (Wegovy) | Experimental | Not described Receives: Drug: Semaglutide |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of eligible to enrolled participants
Feasibility of Wegovy for MeUD treatment: Feasibility will be determined by measuring the ratio of eligible to enrolled participants
Measured: 14 months
Proportion of on-time injections
Acceptability of Wegovy for MeUD treatment: Acceptibility of the treatment will be determined by measuring the adherence to available study drug injections (proportion of on-time injections administered)
Measured: 20 months
Past month methamphetamine use at baseline vs. week 12
Reduced methamphetamine use: Signs of reduced methamphetamine use by hair testing or self-report (timeline follow back) for the past four weeks, measured at baseline vs. week 12.
Measured: 12 weeks
Rate of study-drug discontinuation
Safety of Wegovy for MeUD treatment: Safety will be determined by measuring the rate of study-drug discontinuation due to adverse events
Measured: 12 weeks
Reduced methamphetamine use
Reduced methamphetamine use, measured by proportion achieving "response," defined as 3 out of the final 4 urines collected negative for methamphetamine.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start26 Feb 2026
- Primary completion15 Feb 2030 (estimated)
- Study completion15 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine-dependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Francisco Department of Public Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Phillip Coffin, MD, MIA, San Francisco Department of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204249
- Sponsor's protocol ID
- UG3DA063329
- Acronym
- GEM
- Status last verified
- Jun 2026
- First submitted
- 24 Sep 2025
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glutide for Ending Methamphetamine
- ClinicalTrials.gov ID
- NCT07204249
- Acronym / sponsor ID
- GEM / UG3DA063329
- Conditions
- Methamphetamine-dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- San Francisco Department of Public HealthOther government
- Study start
- 26 Feb 2026 (actual)
- Primary completion
- 15 Feb 2030 (estimated)
- Study completion
- 15 Feb 2030 (estimated)
- First posted
- 2 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
GEM is a two-phase study to evaluate the use of semaglutide (Wegovy) for the treatment of methamphetamine use disorder (MeUD).
The first phase is a pilot study, which will be an open-label, single-arm pilot study of 25 participants. Participants will receive Wegovy over a 12-week treatment period, with a subsequent follow-up visit at week 20. This phase will evaluate the feasibility, acceptability, and preliminary efficacy of Wegovy for MeUD.
The second phase will be a phase IIb randomized-controlled trial to determine the efficacy of Wegovy in treating MeUD. This trial will be similar to the pilot with randomization to Wegovy or placebo and blinding of group assignment. The trial will enroll 162 participants across two sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semaglutide (Wegovy) | Experimental | Drug: Semaglutide |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Ability to provide informed consent before any study-related activity, willing to comply with all study procedures, and be available for the duration of the study,
- Age 18 - 65 years inclusive,
- Moderate to severe Methamphetamine Use Disorder by Structured Clinical Interview for DSM Disorders (SCID),
- Self-reported methamphetamine use ≥15 days out of the past 30,
Key exclusion criteria (31 listed)
- Uncontrolled hypertension or systolic BP >160 mmHg and/or diastolic BP >90 mmHg, averaged from three measurements,
- Diabetes (type 1 or 2), hemoglobin A1c ≥ 6.5 at screening, or history of diabetic ketoacidosis,
- History or current hypoglycemia (blood glucose <70 mg/dL),
- History of malignant neoplasms within the past 5 years prior to screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed.
- History of heart failure or severe gastrointestinal disease (including acute or chronic pancreatitis, any gastric emptying disorder, gallbladder disease; any gastric resection),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SemaglutideSemaglutide | Drug | Semaglutide (Wegovy) |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Ratio of eligible to enrolled participants
Time frame: 14 months
Feasibility of Wegovy for MeUD treatment: Feasibility will be determined by measuring the ratio of eligible to enrolled participants
Proportion of on-time injections
Time frame: 20 months
Acceptability of Wegovy for MeUD treatment: Acceptibility of the treatment will be determined by measuring the adherence to available study drug injections (proportion of on-time injections administered)
Past month methamphetamine use at baseline vs. week 12
Time frame: 12 weeks
Reduced methamphetamine use: Signs of reduced methamphetamine use by hair testing or self-report (timeline follow back) for the past four weeks, measured at baseline vs. week 12.
Rate of study-drug discontinuation
Time frame: 12 weeks
Safety of Wegovy for MeUD treatment: Safety will be determined by measuring the rate of study-drug discontinuation due to adverse events
Reduced methamphetamine use
Time frame: 12 weeks
Reduced methamphetamine use, measured by proportion achieving "response," defined as 3 out of the final 4 urines collected negative for methamphetamine.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Semaglutide in people with Methamphetamine-dependence, run by San Francisco Department of Public Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Phillip O Coffin, MD ((628) 217-6282, phillip.coffin@sfdph.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio of eligible to enrolled participants (time frame: 14 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.