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

Primary Purpose

Opiate Substitution Treatment, Opioid-Related Disorders

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Liraglutide Pen Injector
Placebo
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opiate Substitution Treatment focused on measuring Opiate treatment, Opioid treatment, Glucagon-Like Peptide-1 Agonist, Opioid use disorder, Liraglutide

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
  • Women of childbearing potential must consent to use a medically accepted method of birth control or to abstain from sexual intercourse while in the study
  • Able and willing to provide informed consent prior to any study-related activities
  • Must be able to read and communicate in English sufficiently to complete all study requirements, including EMA

Exclusion Criteria:

  • Age < 18 or > 75 years
  • Women who are pregnant, planning pregnancy, breastfeeding, or unwilling to use adequate contraceptive measures
  • History of angioedema, serious hypersensitivity reaction, or anaphylactic reaction to liraglutide or another glucagon-like peptide-1 receptor (GLP1R) agonist
  • Personal or family history of medullary thyroid carcinoma (MTC) or patients with multiple endocrine neoplasia syndrome type 2 (MEN 2) or thyroid nodule
  • Type I diabetes or history of diabetic ketoacidosis
  • Type II diabetes mellitus
  • Hypoglycemia on intake visit (blood glucose < 70 mg/dL)
  • End-stated renal failure on dialysis or glomerular filtration rate (GFR) <30mL/min per 1.73 square meters or previous renal transplant
  • Severe hepatic impairment (AST or ALT levels > 3 times upper limit of normal range) or previous liver transplant
  • Current or past diagnosis of pancreatitis, gastroparesis, or other severe gastrointestinal disease
  • Current or past diagnosis of gallbladder disease or gallstones
  • Serious cardiovascular disease within the past 6 months (e.g. uncontrolled hypertension, heart failure, significant cardiac arrhythmias, myocardial infarction, presence of angina pectoris, symptomatic coronary artery disease, deep vein thrombosis, pulmonary embolism, second- or third-degree heart block, mitral valve or aortic stenosis, hypertrophic cardiomyopathy, stroke)
  • Current or past history of severe psychiatric disease (e.g. unstable or untreated major depression disorder, bipolar disorder, psychotic disorder, schizophrenia)
  • Suicidal ideation within the past 1 month, or history of suicide attempts with the past 10 years
  • Current use of anti-psychotic medications, mood-stabilizers, or prescription stimulants
  • Treatment with any investigational drug in the one-month preceding the study
  • Previous randomization for participation in this trial
  • Abnormal physical exam findings, vital signs (blood pressure, heart rate, respiratory rate, body temperature), EKG measurements, and safety lab values that are deemed clinically significant by study physician

Sites / Locations

  • Penn State Milton S Hershey Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Investigational group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
Change in ambient drug craving over time as measured by visual analog scale (VAS)
Scores are measured on a 0-100 point VAS, where 0= no craving, 100= maximum craving.

Secondary Outcome Measures

Change in blood pressure
Blood pressure measurements in mmHg. Both systolic and diastolic pressures will be assessed during the study period.
Change in heart rate
Heart rate measurements in beats per minute.
Change in respiratory rate
Respiratory rate in breaths per minute.
Absolute change in body weight
Body weight will be measured in kilograms (kg).
Percent change in body weight
Body weight will be measured in kilograms (kg) and change will measured in %.
Fasting blood samples for fructosamine
Fructosamine is measured in mmol/L
Fasting blood samples for A1c
A1c is measured in mmol/mol
Frequency of adverse events (AE) and serious adverse events (SAE)
Adverse events will only include those that are determined to be related to the study drug.

Full Information

First Posted
December 12, 2019
Last Updated
September 13, 2023
Sponsor
Milton S. Hershey Medical Center
Collaborators
National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT04199728
Brief Title
Use of a GLP-1R Agonist to Treat Opioid Use Disorder
Official Title
Use of a GLP-1R Agonist to Treat Opioid Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2021 (Actual)
Primary Completion Date
October 18, 2023 (Anticipated)
Study Completion Date
October 18, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
Collaborators
National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
The rationale for the proposed research is to develop an acute intervention that can improve treatment outcomes in opioid use disorder (OUD) by reducing craving, a primary factor contributing to early relapse. Although liraglutide was approved for human use in 2010, there are no data testing the effectiveness in patients with an OUD. The objective of the proposed research is to test whether treatment with a GLP-1R agonist can reduce craving in humans with OUD. Understanding how a 'satiety' agent may affect craving and brain responses to drug cues in an OUD population would provide entirely novel information. If liraglutide shows a trend towards efficacy, and safety of the GLP-1R agonist is demonstrated in this population, it would provide an indication to run the second phase, multi-center clinical trial of GLP-1R agonist in OUD patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opiate Substitution Treatment, Opioid-Related Disorders
Keywords
Opiate treatment, Opioid treatment, Glucagon-Like Peptide-1 Agonist, Opioid use disorder, Liraglutide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Investigational group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Liraglutide Pen Injector
Other Intervention Name(s)
Saxenda
Intervention Description
Liraglutide will be provided using an injection pen provided by the manufacturer
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo injection pen
Primary Outcome Measure Information:
Title
Change in self-reported cue-elicited drug craving as measured by visual analog scale (VAS)
Description
Scores are measured on a 0-100 point VAS, where 0= no craving, 100= maximum craving.
Time Frame
Baseline (Day 1), End of the target drug dose (Day 19) [and additionally until Day 31 for 5-dose intervention])
Title
Change in ambient drug craving over time as measured by visual analog scale (VAS)
Description
Scores are measured on a 0-100 point VAS, where 0= no craving, 100= maximum craving.
Time Frame
Baseline (Day 1), then four (4) times per day on the following days: Days 2-3; Days 6-9; Days 12-15; Days 18-21
Secondary Outcome Measure Information:
Title
Change in blood pressure
Description
Blood pressure measurements in mmHg. Both systolic and diastolic pressures will be assessed during the study period.
Time Frame
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])
Title
Change in heart rate
Description
Heart rate measurements in beats per minute.
Time Frame
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])
Title
Change in respiratory rate
Description
Respiratory rate in breaths per minute.
Time Frame
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])
Title
Absolute change in body weight
Description
Body weight will be measured in kilograms (kg).
Time Frame
Daily, from Days 1 to 21 [Days 1- 33 for 5-dose intervention])
Title
Percent change in body weight
Description
Body weight will be measured in kilograms (kg) and change will measured in %.
Time Frame
Daily, from Days 1 to 21 [Days 1- 33 for 5-dose intervention])
Title
Fasting blood samples for fructosamine
Description
Fructosamine is measured in mmol/L
Time Frame
Days 2 and 19 (and additionally at Day 31 for 5-dose intervention]
Title
Fasting blood samples for A1c
Description
A1c is measured in mmol/mol
Time Frame
Days 2 and 19 (and additionally at Day 31 for 5-dose intervention]
Title
Frequency of adverse events (AE) and serious adverse events (SAE)
Description
Adverse events will only include those that are determined to be related to the study drug.
Time Frame
Days 1-21 [Days 1-33 for 5-dose intervention]), and at 30 days post-intervention (Day 49 [Day 61 for 5-dose intervention]).
Other Pre-specified Outcome Measures:
Title
Change in blood oxygenation level response to visual opioid drug cues in prefrontal cortex using Functional Near Infrared Spectroscopy (fNIRs)
Description
fNIRs measures regional cerebral oxygenation saturation (%).
Time Frame
Baseline (Day 1) to end of the target drug dose (Day 19 [additionally Day 31 for 5-dose intervention])
Title
Rebound change in ambient drug craving over time as measured by visual analog scale (VAS)
Description
Scores are measured on a 0-100 point VAS, where 0= no craving, 100= maximum craving.
Time Frame
From end of rebound follow up (Day 21 [Day 33 for 5-dose intervention]) to baseline (Day 1) and to end of the target drug dose (Day 19 [Day 31 for 5-dose intervention])
Title
Rebound change in blood pressure
Description
Blood pressure measurements in mmHg. Both pressures will be assessed during the study period.
Time Frame
From end of the target drug dose (Day 19 [Day 31 for 5-dose intervention]) to rebound follow up (Day 21 [Day 33 for 5-dose intervention]).
Title
Rebound change in heart rate
Description
Heart rate measurements in beats per minute
Time Frame
From end of the target drug dose (Day 19 [Day 31 for 5- dose intervention]) to rebound follow up (Day 21 [Day 33 for 5-dose intervention]).
Title
Rebound change in respiratory rate
Description
Respiratory rate in breaths per minutes.
Time Frame
From end of the target drug dose (Day 19 [Day 31 for 5- dose intervention]) to rebound follow up (Day 21 [Day 33 for 5-dose intervention])
Title
Long-term change in HbA1c
Description
A1c is measured in %.
Time Frame
From Day 2 to end of the target drug dose (Day 19 [Day 31 for 5-dose intervention])
Title
Long-term change in fructosamine levels
Description
Fructosamine measured in mmol/L.
Time Frame
From Day 2 to end of the target drug dose (Day 19 [Day 31 for 5-dose intervention])

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Women of childbearing potential must consent to use a medically accepted method of birth control or to abstain from sexual intercourse while in the study Able and willing to provide informed consent prior to any study-related activities Must be able to read and communicate in English sufficiently to complete all study requirements, including EMA Exclusion Criteria: Age < 18 or > 75 years Women who are pregnant, planning pregnancy, breastfeeding, or unwilling to use adequate contraceptive measures History of angioedema, serious hypersensitivity reaction, or anaphylactic reaction to liraglutide or another glucagon-like peptide-1 receptor (GLP1R) agonist Personal or family history of medullary thyroid carcinoma (MTC) or patients with multiple endocrine neoplasia syndrome type 2 (MEN 2) or thyroid nodule Type I diabetes or history of diabetic ketoacidosis Type II diabetes mellitus Hypoglycemia on intake visit (blood glucose < 70 mg/dL) End-stated renal failure on dialysis or glomerular filtration rate (GFR) <30mL/min per 1.73 square meters or previous renal transplant Severe hepatic impairment (AST or ALT levels > 3 times upper limit of normal range) or previous liver transplant Current or past diagnosis of pancreatitis, gastroparesis, or other severe gastrointestinal disease Current or past diagnosis of gallbladder disease or gallstones Serious cardiovascular disease within the past 6 months (e.g. uncontrolled hypertension, heart failure, significant cardiac arrhythmias, myocardial infarction, presence of angina pectoris, symptomatic coronary artery disease, deep vein thrombosis, pulmonary embolism, second- or third-degree heart block, mitral valve or aortic stenosis, hypertrophic cardiomyopathy, stroke) Severe co-occurring psychiatric disorder (e.g., bipolar disorder, psychotic disorder, schizophrenia) that would, in the opinion of the Principle Investigator or study physician, interfere with participating in the study, such as if the patient needs a higher or different level of care and is going to be transferred out of Caron. Suicidal ideation within the past 1 month, or history of suicide attempts within the past 1 year, unless participation is cleared by clinician assessment and/or judgement. Treatment with any investigational drug in the one-month preceding the study Previous randomization for participation in this trial Abnormal physical exam findings, vital signs (blood pressure, heart rate, respiratory rate, body temperature), EKG measurements, and safety lab values that are deemed clinically significant by study physician
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dora Hunter
Phone
717-531-0003
Ext
343298
Email
dhunter2@pennstatehealth.psu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Bunce, PhD
Organizational Affiliation
Milton S. Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Milton S Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott Bunce, PhD
Phone
717-531-4127
Email
sbunce@pennstatehealth.psu.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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