GLP-1R Agonist
Liraglutide Pen Injector for Opioid Use Disorder
Penn State Milton S Hershey Medical Center, Hershey, PA
Targeting 2 different conditionsLiraglutide Pen Injector +1 morePhase 1 & 2RecruitingLed by Scott Bunce, PhDResearch Sponsored by Milton S. Hershey Medical CenterEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upbaseline (day 1); beginning of each study drug dose (days 2, 8, 14, 19, 20, 26, and 31); and end of rebound follow-up (day 21 [day 33 for 5-dose intervention])
Awards & highlights
All Individual Drugs Already Approved
Study Summary
This trial is testing if liraglutide can help people with opioid addiction by reducing cravings.
Eligible Conditions
- Opioid Use Disorder
- Opiate Substitution Therapy
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (day 1); beginning of each study drug dose (days 2, 8, 14, 19, 20, 26, and 31); and end of rebound follow-up (day 21 [day 33 for 5-dose intervention])
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1); beginning of each study drug dose (days 2, 8, 14, 19, 20, 26, and 31); and end of rebound follow-up (day 21 [day 33 for 5-dose intervention])
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in ambient drug craving over time as measured by visual analog scale (VAS)
Change in self-reported cue-elicited drug craving as measured by visual analog scale (VAS)
Secondary outcome measures
Absolute change in body weight
Change in blood pressure
Change in heart rate
+5 moreOther outcome measures
Change in blood oxygenation level response to visual opioid drug cues in prefrontal cortex using Functional Near Infrared Spectroscopy (fNIRs)
Long-term change in HbA1c
Long-term change in fructosamine levels
+4 moreAwards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Investigational groupExperimental Treatment1 Intervention
Participants randomized to liraglutide will be started at a low dose (0.6 mg once per day) which will be gradually increased until 1.8 mg/day is reached for the 3-dose intervention and 3 mg/day is reached for the 5-dose intervention. Liraglutide will be administered by injection pen.
Group II: Control groupPlacebo Group1 Intervention
Participants in the control group will have placebo administered by injection pen following the same low dose titration to 3.0 mg once per day.
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Who is running the clinical trial?
Milton S. Hershey Medical CenterLead Sponsor
476 Previous Clinical Trials
2,785,935 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,611 Previous Clinical Trials
6,804,850 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,368 Previous Clinical Trials
2,049,076 Total Patients Enrolled
Scott Bunce, PhDPrincipal Investigator
Milton S. Hershey Medical CenterMedia Library
Frequently Asked Questions
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