Phase 2
N=25
Use of a GLP-1R Agonist to Treat Opioid Use Disorder
Opiate Substitution Treatment · Opioid-Related Disorders
Bottom Line
View on ClinicalTrials.gov: NCT04199728 ↗Enrolled (actual)
25
Serious AEs
12.0%
Results posted
Nov 2024
Primary outcome: Primary: Change in Self-reported Cue-elicited Drug Craving as Measured by Visual Analog Scale (VAS) — -5.00; -13.34 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Liraglutide Pen Injector (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Milton S. Hershey Medical Center
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Self-reported Cue-elicited Drug Craving as Measured by Visual Analog Scale (VAS) |
-5.00; -13.34 | — |
| PRIMARY Change in Ambient Drug Craving Over Time as Measured by Visual Analog Scale (VAS) |
-0.55; -1.41 | — |
| SECONDARY Change in Blood Pressure |
4.00; -0.59; 9.00; 2.75; 3.75; 2.13 | — |
| SECONDARY Change in Heart Rate |
10.75; -5.78; 20.00; -2.63; 9.75; -3.09 | — |
| SECONDARY Change in Respiratory Rate |
-1.00; 0.08; 0.67; -1.08; 1.33; -0.13 | — |
| SECONDARY Absolute Change in Body Weight |
0.27; 1.05 | — |
| SECONDARY Percent Change in Body Weight |
0.33; 1.38 | — |
| SECONDARY Change in Fasting Blood Samples for Fructosamine |
-14.00; 2.71 | — |
| SECONDARY Change in Fasting Blood Samples for HA1c |
-0.10; 0 | — |
| SECONDARY Frequency of Adverse Events (AE) and Serious Adverse Events (SAE) |
5; 3; 1; 0 | — |
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.
Eligibility 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 Ecology Momentary Assessment (EMA)
Exclusion Criteria
- Age 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 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
Data sourced from ClinicalTrials.gov (NCT04199728). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.