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SHIFT

Not yet recruitingPhase 2

Semaglutide for Treatment of People With Methamphetamine Use Disorder: the SHIFT Study

Lead sponsor

Kirby Institute

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

NCT IDNCT07509112
Org study IDVHCRP2502

Timeline

Milestones

Study first posted2026-04-03actual
Last update posted2026-04-03actual
Study start2026-05estimated (month precision)
Primary completion2027-01estimated (month precision)
Study completion2027-03estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Alcohol / substance use

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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

Other clinical outcomes
6
Other (unclassified)
4
Safety / tolerability / PK
3
Weight & body composition
1
Patient-reported / QoL
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint/low confidence

Secondary exploratory outcome

Time frame:12 weeks

descriptive, improvement

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

Secondary exploratory outcome

Time frame:12 weeks

EQ-5D index

change from baseline, improvement

Safety / tolerability / PK

3 endpoints
Other/protocol endpoint/low confidence

Feasibility - acceptance

Time frame:Baseline to week 12

descriptive

componentsDiscontinuation due to AE, PGI, change

Other/protocol endpoint

Safety - adverse events

Time frame:12 weeks

Treatment-emergent AEs (any)

descriptive

Other/protocol endpoint

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 endpoints
Primary/protocol endpoint/low confidence

Efficacy Outcome (exploratory)

Time frame:12 weeks

Alcohol consumption, change

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Secondary exploratory outcome

Time frame:12 weeks

Alcohol consumption, change

descriptive, improvement

Secondary/protocol endpoint

Secondary exploratory outcome

Time frame:12 weeks

categorical status, improvement

Secondary/protocol endpoint/low confidence

Secondary exploratory outcome

Time frame:12 weeks

categorical status, improvement

Secondary/protocol endpoint

Secondary exploratory outcome

Time frame:12 weeks

change from baseline, improvement

Secondary/protocol endpoint

Secondary exploratory outcome

Time frame:12 weeks

categorical status, improvement

Other (unclassified)

4 endpoints
Other/protocol endpoint

Feasibility - recruitment

Time frame:Screening to week 14 end of study follow up visit

descriptive

Other/protocol endpoint

Feasibility - retention

Time frame:Screening to week 14 end of study follow up visit

descriptive

Other/protocol endpoint/low confidence

Feasibility - adherence

Time frame:Baseline to week 12

descriptive

Other/protocol endpoint

Feasibility - data completeness

Time frame:Screening to week 14 end of study follow up visit

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.