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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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Semaglutide

    Drug

    Semaglutide

  • Placebo

    Drug

    Placebo

Treatment groups

162 Participants
are divided into 2 treatment groups
Group A: Semaglutide (Wegovy)Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
14 months
2

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)

Time frame
20 months
3

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.

Time frame
12 weeks
4

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

Time frame
12 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

San Francisco Department of Public Health

Lead sponsor

Source ClinicalTrials.gov
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