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SHIFT
Not yet recruitingPhase 2Semaglutide for Treatment of People With Methamphetamine Use Disorder: the SHIFT Study
Lead sponsor
Asset
Semaglutide
Subcutaneous · GLP-1 agonist
Listed sites
5
Recruiting sites
—
Enrollment
40
estimated
Study population
Alcohol / substance use
Key I/E criterion
—
Primary endpoint
•Alcohol consumption, change
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Has provided voluntary, written informed consent;
2. Aged 18 years or older;
3. Diagnosed with moderate to severe methamphetamine use disorder (DSM-5 criteria);
4. Self-reported methamphetamine use on at least 14 of past 28 days and a positive oral fluid drug screen for amphetamine/methamphetamine;
5. Willing and able to comply with study procedures and follow-up visits;
6. People of child-bearing potential must agree to use effective contraception during treatment and during the 60 days after treatment end.
Exclusion criteria
1. Uncontrolled medical or psychiatric conditions that may interfere with participation;
2. Body mass index less than 22 kg/m2;
3. Confirmed diagnosis of diabetes mellitus (either known history of diabetes; concomitant treatment with insulin, metformin, sulfonylureas, thiazolidinediones, SGLT2 inhibitor, DPP4 inhibitor; or HbA1c >6.5 at screening);
4. Currently taking a GLP-1 receptor agonist;
5. Known hypersensitivity or contraindications to GLP-1 receptor agonists as per product information;
6. Current enrolment in another interventional trial;
7. Lactating, pregnant or at risk of pregnancy not willing to avoid pregnancy
8. History of pancreatitis;
9. History of medullary thyroid cancer;
10. Current admission to a residential rehabilitation program or inpatient program or planned admission during the study period, which would interfere with participation in study visits or procedures;
11. Currently experiencing psychosis or current active suicidality
12. Any condition or circumstance that, in the opinion of the investigator, would compromise the participant's ability to comply with the study procedures, complete protocol requirements, or provide reliable data.
Endpoints (15)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
1 endpointSecondary exploratory outcome
Time frame:12 weeks
descriptive, improvement
Patient-reported / QoL
1 endpointSecondary exploratory outcome
Time frame:12 weeks
EQ-5D index
change from baseline, improvement
Safety / tolerability / PK
3 endpointsFeasibility - acceptance
Time frame:Baseline to week 12
descriptive
componentsDiscontinuation due to AE, PGI, change
Safety - adverse events
Time frame:12 weeks
Treatment-emergent AEs (any)
descriptive
Safety - treatment-related serious adverse events
Time frame:12 weeks
Serious AEs (any)
composite event, event
componentsSerious AEs (any), Discontinuation due to AE
Other clinical outcomes
6 endpointsEfficacy Outcome (exploratory)
Time frame:12 weeks
Alcohol consumption, change
change from baseline, improvement
Secondary exploratory outcome
Time frame:12 weeks
Alcohol consumption, change
descriptive, improvement
Secondary exploratory outcome
Time frame:12 weeks
categorical status, improvement
Secondary exploratory outcome
Time frame:12 weeks
categorical status, improvement
Secondary exploratory outcome
Time frame:12 weeks
change from baseline, improvement
Secondary exploratory outcome
Time frame:12 weeks
categorical status, improvement
Other (unclassified)
4 endpointsFeasibility - recruitment
Time frame:Screening to week 14 end of study follow up visit
descriptive
Feasibility - retention
Time frame:Screening to week 14 end of study follow up visit
descriptive
Feasibility - adherence
Time frame:Baseline to week 12
descriptive
Feasibility - data completeness
Time frame:Screening to week 14 end of study follow up visit
descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.