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
Active Not Recruiting

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

First listed
Nov 15, 2024
Start date
Aug 7, 2025
Status verified
Sep 2026
Primary completion
Jan 31, 2027
Completion
Jul 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 ]

Locations (2)

FacilityCityStateZIPSite coordinators
Institute of Human Virology at the University of Maryland School of MedicineWashington D.C.District of Columbia20002-
Institute of Human Virology at the University of Maryland School of MedicineBaltimoreMaryland21201-

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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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