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 range18 Years – 75 Years
SexALL
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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…
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)