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GLP-1R Agonist Treatment for Opioid Use Disorder

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 months later Nov 2026 → Apr 2027
See other at-risk trials from Milton S. Hershey Medical Center

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion dates: Apr 2027 to Apr 30, 2027
    • Start date: Jan 13, 2025 to Jan 27, 2025
    • Site details revised at 1 of 4 sites
    v11
  2. Eligibility criteria expanded, about 7 wordsv10
  3. Primary and study completion pushed from Nov 2026 to Apr 2027
    • Study sites: 3 to 4
    • Collaborators: 3 to 4
    v9
  4. Study description expanded, about 23 words
    • Site details revised at 2 of 3 sites
    v8
  5. Study description shortened, about 12 words
    • Eligibility criteria expanded, about 4 words
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Study sites: 1 to 3
    • Eligibility criteria expanded, about 20 words
    v6
  2. Trial status: Not Yet Recruiting to Recruitingv5 Show 4 more changesShow less
    • Start date changed from estimate of Jan 2025 to Jan 13, 2025
    • Eligibility criteria expanded, about 93 words
    • Site details revised
    • Study description expanded, about 2 words
  3. Start date: Nov 2024 to Jan 2025v4
  4. Lead sponsor: Patricia Sue Grigson to Milton S. Hershey Medical Center
    • Start date: Sep 2024 to Nov 2024
    v3
  5. Study description shortened, about 2 wordsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06548490
Lead Sponsor Milton S. Hershey Medical Center
Collaborators: New York University, University of Maryland, National Institute on Drug Abuse (NIDA), Stanley Street Treatment and Resources (SSTAR)
Conditions
(from sponsor)		 Opioid Use Disorder, Opioid Abuse and Addiction, Narcotic-Related Disorders, Substance-Related Disorders, Chemically-Induced Disorders, Mental Disorder, Opioid
Related terms Behavior, Addictive, Chemically-Induced Disorders, Mental Disorders, Narcotic-Related Disorders, Opioid-Related Disorders, Substance-Related Disorders
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov