GLP-1R Agonist Treatment for Opioid Use Disorder

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Milton S. Hershey Medical Center
Study ID
NCT06548490
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Chemically-Induced Disorders
  • Mental Disorder
  • Narcotic-Related Disorders
  • Opioid
  • Opioid Abuse and Addiction
  • Opioid Use Disorder
  • Substance-Related Disorders

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide Pen Injector — DRUG
    Semaglutide will be provided using an injection pen
  • Placebo — DRUG
    Placebo will be a dry needle stick; no substances will be injected

Study Details

The goal of this clinical trial is to learn if semaglutide can reduce illicit opioid use in adults in outpatient treatment for opioid use disorder, and who are receiving either buprenorphine or methadone maintenance treatment. The main question it aims to answer is: • Does semaglutide increase the likelihood that participants will refrain from using illicit and nonprescribed opioids? The investigators will compare semaglutide to a placebo (a needle prick that contains no drug) to see if semaglutide works to reduce use of illicit and nonprescribed opioids. The participants will: * Take semaglutide or a placebo every week for 12 weeks * Visit the clinic every week for urine drug screening and pregnancy testing, vital signs, and to complete mental health and drug use questionnaires * Complete smartphone surveys sent at set times during the study

Key Dates

Start date
Jan 13, 2025
Status verified
Aug 2025
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

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

Arms

  • Experimental: Investigational group
    Participants randomized to semaglutide will be started at a low dose (0.25 mg once per week) which will be gradually increased weekly until 1.0 mg is reached at Week 4 of the intervention.
  • Placebo Comparator: Control group
    Participants in the control group will have placebo administered once per week.

Primary Outcome Measure

Number of participants being abstinent from illicit and nonprescribed opioids. [ Time Frame: Study week 2 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of Maryland BaltimoreBaltimoreMaryland21223
Eric Weintraub
[email protected]
Eric Weintraub, MD (PRINCIPAL_INVESTIGATOR)
NYU Langone HealthNew YorkNew York10016
Mat Kladney
[email protected]
929 573 0673
Mathew Kladney, MD (PRINCIPAL_INVESTIGATOR)
Pennsylvania Psychiatric InstituteHarrisburgPennsylvania17110
Subi Upadhyay
[email protected]
Angela Spangler
[email protected]
(717) 683-7838
Sarah Kawasaki, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Maryland Baltimore· Baltimore, MDNYU Langone Health· New York, NYPennsylvania Psychiatric Institute· Harrisburg, PA

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