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GLP-1R Agonist

Liraglutide Pen Injector for Opioid Use Disorder

Phase 1 & 2
Waitlist Available
Led By Scott Bunce, PhD
Research Sponsored by Milton S. Hershey Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
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])
Awards & highlights

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 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])
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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]) for reporting.

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 more
Other 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 more

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Liraglutide Pen Injector
2021
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor
492 Previous Clinical Trials
2,798,795 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,561 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,464 Previous Clinical Trials
2,618,566 Total Patients Enrolled

Media Library

Liraglutide (GLP-1R Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04199728 — Phase 1 & 2
Opioid Use Disorder Research Study Groups: Control group, Investigational group
Opioid Use Disorder Clinical Trial 2023: Liraglutide Highlights & Side Effects. Trial Name: NCT04199728 — Phase 1 & 2
Liraglutide (GLP-1R Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04199728 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Use of a GLP-1R Agonist to Treat Opioid Use Disorder
Scott C Bunce, PhD 2021. "Use of a GLP-1R Agonist to Treat Opioid Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04199728.
~8 spots leftby Apr 2025
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