Evaluation Of Semaglutide in Adults With Cocaine Use Disorder With and Without HIV

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
University of Maryland, Baltimore
Study ID
NCT06691243
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Cocaine Use Disorder
  • HIV

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide — DRUG
    The initial dose will be semaglutide 0.25mg which, if tolerated, will be escalated to 0.5mg. Escalation will continue to 1.0 mg and afterwards to 2.0 mg. The highest possible dose will be 2.0mg semaglutide.
  • Placebo — DRUG
    Patients randomized to placebo arm will receive placebo injection every week.

Study Details

The purpose of this research study is to find out if semaglutide is safe and well tolerated in adults with cocaine use disorder who do and do not have human immunodeficiency virus (HIV). Participants will complete a screening process and if you are able to participate, you will be assigned to one of two treatment groups: semaglutide or placebo. Participants will: * Visit the clinic once a week for semaglutide or placebo injections * Visit the clinic once every two weeks for labwork, assessments and/or surveys * If consented to optional MRI's, complete two MRI's

Key Dates

Start date
Aug 7, 2025
Status verified
Aug 2025
Primary completion
Jul 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Semaglutide
    Once weekly injection of semaglutide
  • Placebo Comparator: Placebo
    Once weekly injection of placebo

Primary Outcome Measure

Safety of semaglutide in patients with cocaine use disorder (CUD) with and without HIV [ Time Frame: 16 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Institute of Human Virology at the University of Maryland School of MedicineWashington D.C.District of Columbia20002
Emade Ebah
[email protected]
240-667-6202
Institute of Human Virology at the University of Maryland School of MedicineBaltimoreMaryland21201
Onyinyechi Ogbumbadiugha-Weekes
[email protected]
443-635-4943

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By condition
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By specialty
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By research site
Institute of Human Virology at the University of Maryland School of Medicine· Washington D.C., DCInstitute of Human Virology at the University of Maryland School of Medicine· Baltimore, MD

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