Use of a GLP-1R Agonist to Treat Opioid Use Disorder (NCT04199728) | Clinical Trial Compass
CompletedPhase 1/2
Use of a GLP-1R Agonist to Treat Opioid Use Disorder
United States27 participantsStarted 2021-10-18
Plain-language summary
This research is being done to find out if liraglutide (brand name is Saxenda®) can safely and effectively reduce craving for opioids in patients with opioid use disorder, a primary factor contributing to early relapse.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18 to 75 years
* Diagnosed with an OUD seeking treatment at Caron Treatment Centers (CaronTC) and planning on being enrolled in a residential treatment plan for a minimum of 4 weeks
* Women of childbearing potential must consent to use a medically accepted method of birth control or to abstain from sexual intercourse while in the study
* Able and willing to provide informed consent prior to any study-related activities
* Must be able to read and communicate in English sufficiently to complete all study requirements, including Ecology Momentary Assessment (EMA)
Exclusion Criteria:
* Age \< 18 or \> 75 years
* Women who are pregnant, planning pregnancy, breastfeeding, or unwilling to use adequate contraceptive measures
* History of angioedema, serious hypersensitivity reaction, or anaphylactic reaction to liraglutide or another glucagon-like peptide-1 receptor (GLP1R) agonist
* Personal or family history of medullary thyroid carcinoma (MTC) or patients with multiple endocrine neoplasia syndrome type 2 (MEN 2) or thyroid nodule
* Type I diabetes or history of diabetic ketoacidosis
* Type II diabetes mellitus
* Hypoglycemia on intake visit (blood glucose \< 70 mg/dL)
* End-stage renal failure on dialysis or glomerular filtration rate (GFR) \<30 mL/min per 1.73 square meters or previous renal transplant
* Severe hepatic impairment (AST or ALT levels \> 3 times upper limit of normal range) or previous liver transplant
* Current or past diagnosis of panc…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Self-reported Cue-elicited Drug Craving as Measured by Visual Analog Scale (VAS)
Timeframe: Baseline (Day 1), End of the target drug dose (Day 19)
2
Change in Ambient Drug Craving Over Time as Measured by Visual Analog Scale (VAS)
Timeframe: Baseline (Day 1), Treatment Days (Days 2-19)