Use of a GLP-1R Agonist to Treat Opioid Use Disorder

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Milton S. Hershey Medical Center
• Collaborators: National Institute on Drug Abuse (NIDA); National Institutes of Health (NIH)
• Treatments: Analgesics, Opioid; Liraglutide

Criteria

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 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-stated renal failure on dialysis or glomerular filtration rate (GFR) <30mL/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 pancreatitis, gastroparesis, or other severe gastrointestinal disease

• Current or past diagnosis of gallbladder disease or gallstones

• Serious cardiovascular disease within the past 6 months (e.g. uncontrolled hypertension, heart failure, significant cardiac arrhythmias, myocardial infarction, presence of angina pectoris, symptomatic coronary artery disease, deep vein thrombosis, pulmonary embolism, second- or third-degree heart block, mitral valve or aortic stenosis, hypertrophic cardiomyopathy, stroke)

• Current or past history of severe psychiatric disease (e.g. unstable or untreated major depression disorder, bipolar disorder, psychotic disorder, schizophrenia)

• Suicidal ideation within the past year, or history of suicide attempts with the past 10 years

• Current use of anti-psychotic medications, mood-stabilizers, or prescription stimulants

• Treatment with any investigational drug in the one-month preceding the study

• Previous randomization for participation in this trial

• Abnormal physical exam findings, vital signs (blood pressure, heart rate, respiratory rate, body temperature), EKG measurements, and safety lab values that are deemed clinically significant by study physician