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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
27
Liraglutide will be provided using an injection pen provided by the manufacturer
Placebo injection pen
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
Change in Self-reported Cue-elicited Drug Craving as Measured by Visual Analog Scale (VAS)
Scores are measured on a 0-100 point VAS, where 0= no craving, 100= maximum craving.
Time frame: Baseline (Day 1), End of the target drug dose (Day 19)
Change in Ambient Drug Craving Over Time as Measured by Visual Analog Scale (VAS)
Scores are measured on a 0-4 point VAS, where 0= no craving, 4= maximum craving.
Time frame: Baseline (Day 1), Treatment Days (Days 2-19)
Change in Blood Pressure
Blood pressure measurements in mmHg. Both systolic and diastolic pressures will be assessed during the study period.
Time frame: Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14)
Change in Heart Rate
Heart rate measurements in beats per minute.
Time frame: Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14)
Change in Respiratory Rate
Respiratory rate in breaths per minute.
Time frame: Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14)
Absolute Change in Body Weight
Body weight will be measured in kilograms (kg).
Time frame: From Day 1 to Day 19
Percent Change in Body Weight
Body weight will be measured in kilograms (kg) and change will measured in %.
Time frame: From Day 1 to Day 19
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Change in Fasting Blood Samples for Fructosamine
Fructosamine is measured in umol/L
Time frame: From Day 2 to Day 19
Change in Fasting Blood Samples for HA1c
HA1c is measured in %
Time frame: From Day 2 to Day 19
Frequency of Adverse Events (AE) and Serious Adverse Events (SAE)
Number of participants affected by probable drug-related adverse events.
Time frame: Days 1-21 and at 30 days post-intervention (Day 49).