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GLP-1R Agonist

Use of a GLP-1R Agonist to Treat 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 treatment (averaged across days 2-19), rebound follow up (averaged across days 20-21)

Summary

This trial is testing if liraglutide can help people with opioid addiction by reducing cravings.

Eligible Conditions

Opioid Addiction
Opioid Use Disorder
Opiate Substitution Therapy

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ treatment (averaged across days 2-19), rebound follow up (averaged across days 20-21)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~treatment (averaged across days 2-19), rebound follow up (averaged across days 20-21)

This trial's timeline: 3 weeks for screening, Varies for treatment, and treatment (averaged across days 2-19), rebound follow up (averaged across days 20-21) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Absolute Change in Body Weight

Change in Blood Pressure

Change in Fasting Blood Samples for Fructosamine

+5 more

Other study objectives

Change in Blood Oxygenation Level Response to Visual Opioid Drug Cues in Prefrontal Cortex Using Functional Near Infrared Spectroscopy (fNIRs)

Rebound Change in Ambient Drug Craving Over Time as Measured by Visual Analog Scale (VAS)

Rebound Change in Blood Pressure

+2 more

Side effects data

From 2023 Phase 1 & 2 trial • 27 Patients • NCT04199728

33%

Nausea

25%

GI/abdominal upset

25%

Headache

17%

Constipation

Shakiness, diaphoresis, and tremor

Night terrors

Bleeding under Dexcom sensor

Skin irritation spots

Light headed

Intrusive thoughts or images

Overdose to illicit drug

Fatigue

Vasovagal syncope

Decreased appetite

100%

80%

60%

40%

20%

Study treatment Arm

Investigational Group

Control Group

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

~30

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