Actively Recruiting
GLP-1R Agonist Treatment for Opioid Use Disorder
Led by Milton S. Hershey Medical Center · Updated on 2025-08-14
200
Participants Needed
3
Research Sites
93 weeks
Total Duration
On this page
Sponsors
M
Milton S. Hershey Medical Center
Lead Sponsor
N
New York University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
GLP-1R Agonist Treatment for Opioid Use Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years.
- Body mass index (BMI) greater than 18.
- Able and willing to provide informed consent before any study activities.
- Current diagnosis of opioid use disorder as confirmed by MINI or site clinic diagnosis.
- Receiving outpatient treatment for opioid use disorder with at least 2 weeks on buprenorphine or 4 weeks on methadone.
- At least one positive urine test for opioids after starting buprenorphine or methadone treatment.
- Self-reported opioid use after starting buprenorphine or methadone treatment.
- If able to become pregnant, not pregnant or breastfeeding at enrollment and agrees to use birth control or abstain from sexual intercourse during the study.
- Able to read and communicate in English to complete study requirements.
- Able and willing to follow the entire 19-week study protocol.
- Not currently a prisoner.
You will not qualify if you...
- Age under 18 or over 75 years.
- Body mass index (BMI) less than 18.
- Pregnant, planning pregnancy, breastfeeding, or unwilling to use adequate contraception.
- Current use of GLP-1R agonists.
- History of angioedema, serious allergic reaction, or anaphylaxis to semaglutide or other GLP-1R agonists.
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome Type 2.
- Type 1 diabetes or history of diabetic ketoacidosis.
- Type 2 diabetes or current use of dipeptidyl peptidase-4 inhibitors.
- Use of certain medications in the past 30 days that may interact with semaglutide.
- Low blood sugar (hypoglycemia) at intake visit.
- Severe kidney or liver disease, including dialysis or organ transplant.
- History of pancreatitis, gastroparesis, or serious gastrointestinal disease.
- History of gallbladder disease or gallstones.
- Serious cardiovascular disease within the past 6 months.
- Severe psychiatric disorders or dementia affecting safety or compliance.
- Significant suicide risk or recent suicide attempts unless cleared by clinician.
- Use of investigational drugs within 1 month before the study.
- Contraindications to both methadone and buprenorphine or to GLP-1R agonists.
- Previous participation in this trial.
- Any condition or plans that would interfere with safe participation or study visits.
- Currently a prisoner.
AI-Screening
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Trial Site Locations
Total: 3 locations
1
University of Maryland Baltimore
Baltimore, Maryland, United States, 21223
Actively Recruiting
2
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
3
Pennsylvania Psychiatric Institute
Harrisburg, Pennsylvania, United States, 17110
Actively Recruiting
Research Team
J
Jennifer Nyland, PhD
CONTACT
K
Kirsten Shuler, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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