DRUG
Liraglutide Pen Injector
Liraglutide will be provided using an injection pen provided by the manufacturer
Status
Completed
Phase
Phase 1 / Phase 2
Enrollment
27
Locations
1
Results
Posted
Publications
1
Study 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.
The rationale for the proposed research is to develop an acute intervention that can improve treatment outcomes in opioid use disorder (OUD) by reducing craving, a primary factor contributing to early relapse. Although liraglutide was approved for human use in 2010, there are no data testing the effectiveness in patients with an OUD. The objective of the proposed research is to test whether treatment with a GLP-1R agonist can reduce craving in humans with OUD. Understanding how a 'satiety' agent may affect craving and brain responses to drug cues in an OUD population would provide entirely novel information. If liraglutide shows a trend towards efficacy, and safety of the GLP-1R agonist is demonstrated in this population, it would provide an indication to run the second phase, multi-center clinical trial of GLP-1R agonist in OUD patients.
Interventions
DRUG
Liraglutide will be provided using an injection pen provided by the manufacturer
DRUG
Placebo injection pen
Timeline
First posted
Dec 16, 2019
Study start
Oct 18, 2021
Primary completion
Sep 13, 2023
Study completion
Sep 13, 2023
Results posted
Nov 6, 2024
Registry updated
Nov 6, 2024
Outcomes
Change in Self-reported Cue-elicited Drug Craving as Measured by Visual Analog Scale (VAS)
Time frame · Baseline (Day 1), End of the target drug dose (Day 19)
Scores are measured on a 0-100 point VAS, where 0= no craving, 100= maximum craving.
Change in Ambient Drug Craving Over Time as Measured by Visual Analog Scale (VAS)
Time frame · Baseline (Day 1), Treatment Days (Days 2-19)
Scores are measured on a 0-4 point VAS, where 0= no craving, 4= maximum craving.
Change in Blood Pressure
Time frame · Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14)
Blood pressure measurements in mmHg. Both systolic and diastolic pressures will be assessed during the study period.
Change in Heart Rate
Time frame · Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14)
Heart rate measurements in beats per minute.
Change in Respiratory Rate
Time frame · Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14)
Respiratory rate in breaths per minute.
Absolute Change in Body Weight
Time frame · From Day 1 to Day 19
Body weight will be measured in kilograms (kg).
Percent Change in Body Weight
Time frame · From Day 1 to Day 19
Body weight will be measured in kilograms (kg) and change will measured in %.
Change in Fasting Blood Samples for Fructosamine
Time frame · From Day 2 to Day 19
Fructosamine is measured in umol/L
Change in Fasting Blood Samples for HA1c
Time frame · From Day 2 to Day 19
HA1c is measured in %
Frequency of Adverse Events (AE) and Serious Adverse Events (SAE)
Time frame · Days 1-21 and at 30 days post-intervention (Day 49).
Number of participants affected by probable drug-related adverse events.
Eligibility
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 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) * Severe co-occurring psychiatric disorder (e.g., bipolar disorder, psychotic disorder, schizophrenia) that would, in the opinion of the Principle Investigator or study physician, interfere with participating in the study, such as if the patient needs a higher or different level of care and is going to be transferred out of Caron. * Suicidal ideation within the past 1 month, or history of suicide attempts within the past 1 year, unless participation is cleared by clinician assessment and/or judgement. * 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
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
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