Glutide for Ending Methamphetamine
San Francisco Department of Public Health
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. 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.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: 1. 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, 2. Age 18 - 65 years inclusive, 3. Moderate to severe Methamphetamine Use Disorder by Structured Clinical Interview for DSM Disorders (SCID), 4. Self-reported methamphetamine use ≥15 days out of the past 30, 5. Methamphetamine-positive urine during screening and run-in period, 6. Interested in stopping or reduc…
Interventions
- DrugSemaglutide
Semaglutide
- DrugPlacebo
Placebo
Location
- Center on Substance Use and HealthSan Francisco, California