Glutide for Ending Methamphetamine
ConditionMethamphetamine-dependence
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSan Francisco Department of Public Health
About this trial
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 criteria
Qualifiers
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,
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Semaglutide
- Placebo
Treatment groups
162 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov