NCT06548490 GLP-1R Agonist Treatment for Opioid Use Disorder
| NCT ID | NCT06548490 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Milton S. Hershey Medical Center |
| Condition | Opioid Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-01-13 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 200 participants in total. It began in 2025-01-13 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
Inclusion Criteria: * Age 18 to 75 years. * Body mass index (BMI) \> 18. * Able and willing to provide informed consent prior to any study-related activities. * Current diagnosis of Diagnostic and Statistical Manual Diploma in Social Medicine (DSM)-5 Opioid Use Disorder (OUD) as per the Mini International Neuropsychiatric Interview (MINI) or per the site clinic diagnosis. Patients are eligible if they have a MINI \> 3 ("moderate" or "severe" in the "Specify If" box in the Substance Use Disorder (Non-Alcohol) module for the category of opiates). * Currently receiving outpatient treatment for OUD and at least 2 weeks on buprenorphine (BUP) or 4 weeks on methadone at the study site and/or at an associated clinic at the time of enrollment. * Have at least 1 urine test positive for opioids after 2 weeks on BUP or 4 weeks on methadone. * Have positive self-reporting of opioid use after 2 weeks on BUP or 4 weeks on methadone. * If anatomically capable of becoming pregnant and of childbearing
Frequently Asked Questions
Who can join the NCT06548490 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Opioid Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06548490 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06548490 currently recruiting?
Yes, NCT06548490 is actively recruiting participants. Visit ClinicalTrials.gov or contact Milton S. Hershey Medical Center to inquire about joining.
Where is the NCT06548490 trial being conducted?
This trial is being conducted at Baltimore, United States, New York, United States, Harrisburg, United States.
Who is sponsoring the NCT06548490 clinical trial?
NCT06548490 is sponsored by Milton S. Hershey Medical Center. The trial plans to enroll 200 participants.