Trials Sponsors Conditions Drugs Pricing

Conditions

Opiate Substitution Treatment Opioid-Related Disorders

Keywords

Opiate treatmentOpioid treatmentGlucagon-Like Peptide-1 AgonistOpioid use disorderLiraglutide

Outcome Measures

Primary Outcomes (2)

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.
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.
Baseline (Day 1), Treatment Days (Days 2-19)

Secondary Outcomes (8)

Change in Blood Pressure
Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14)
Change in Heart Rate
Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14)
Change in Respiratory Rate
Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14)
Absolute Change in Body Weight
From Day 1 to Day 19
Percent Change in Body Weight
From Day 1 to Day 19
+3 more secondary outcomes

Other Outcomes (5)

Change in Blood Oxygenation Level Response to Visual Opioid Drug Cues in Prefrontal Cortex Using Functional Near Infrared Spectroscopy (fNIRs)
Baseline (Day 1), end of the target drug dose (Day 19)
Rebound Change in Ambient Drug Craving Over Time as Measured by Visual Analog Scale (VAS)
Treatment (averaged across Days 2-19), Rebound follow up (averaged across Days 20-21)
Rebound Change in Blood Pressure
From end of the target drug dose (Day 19) to rebound follow up (Day 21).
+2 more other outcomes

Study Arms (2)

Investigational group

EXPERIMENTAL

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.

Drug: Liraglutide Pen Injector

Control group

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Liraglutide Pen InjectorDrug

Liraglutide will be provided using an injection pen provided by the manufacturer

Also known as: Saxenda

Investigational group

PlaceboDrug

Placebo injection pen

Control group

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age 18 to 75 years
Diagnosed with an OUD seeking treatment at Caron Treatment Centers (CaronTC) and planning on being enrolled in a residential treatment plan for a minimum of 4 weeks

Sponsors & Collaborators

National Institutes of Health (NIH)
NIHcollaborator
National Institute on Drug Abuse (NIDA)
NIHcollaborator
Milton S. Hershey Medical Center

Study Sites (1)

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Related Publications (1)

Freet CS, Evans B, Brick TR, Deneke E, Wasserman EJ, Ballard SM, Stankoski DM, Kong L, Raja-Khan N, Nyland JE, Arnold AC, Krishnamurthy VB, Fernandez-Mendoza J, Cleveland HH, Scioli AD, Molchanow A, Messner AE, Ayaz H, Grigson PS, Bunce SC. Ecological momentary assessment and cue-elicited drug craving as primary endpoints: study protocol for a randomized, double-blind, placebo-controlled clinical trial testing the efficacy of a GLP-1 receptor agonist in opioid use disorder. Addict Sci Clin Pract. 2024 Jul 27;19(1):56. doi: 10.1186/s13722-024-00481-7.
PMID: 39061093DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

Title: Dr. Scott Bunce
Organization: Penn State College of Medicine

Study Officials

Scott Bunce, PhD
Milton S. Hershey Medical Center
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

27 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Associate Professor of Psychiatry

Study Record Dates

First Submitted

December 12, 2019

First Posted

December 16, 2019

Study Start

October 18, 2021

Actual (reported)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (8)

Other Outcomes (5)

Study Arms (2)

Investigational group

Control group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations