Use of a GLP-1R Agonist to Treat Opioid Use Disorder

Part of paid clinical trials in Hershey, Pennsylvania.

Sponsor
Milton S. Hershey Medical Center
Study ID
NCT04199728
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Opiate Substitution Treatment
  • Opioid-Related Disorders

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Liraglutide Pen Injector — DRUG
    Liraglutide will be provided using an injection pen provided by the manufacturer
  • Placebo — DRUG
    Placebo injection pen

Study Details

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.

Key Dates

Start date
Oct 18, 2021
Status verified
Nov 2024
Primary completion
Sep 13, 2023
Completion
Sep 13, 2023

Study Design

Enrollment
27 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Investigational group
    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.
  • Placebo Comparator: Control group
    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.

Primary Outcome Measure

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) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Penn State Milton S Hershey Medical CenterHersheyPennsylvania17033-

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Penn State Milton S Hershey Medical Center· Hershey, PA

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