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

November 1, 2024 updated by: Scott C Bunce, PhD, Milton S. Hershey Medical Center
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Milton S Hershey Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Ecology Momentary Assessment (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-stage renal failure on dialysis or glomerular filtration rate (GFR) <30 mL/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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: Liraglutide Pen Injector
Liraglutide will be provided using an injection pen provided by the manufacturer
Other Names:
  • Saxenda
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.
Drug: Placebo
Placebo injection pen

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
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)
Time Frame: Baseline (Day 1), Treatment Days (Days 2-19)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Blood Pressure
Time Frame: Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14)
Blood pressure measurements in mmHg. Both systolic and diastolic pressures will be assessed during the study period.
Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14)
Change in Heart Rate
Time Frame: Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14)
Heart rate measurements in beats per minute.
Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14)
Change in Respiratory Rate
Time Frame: Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14)
Respiratory rate in breaths per minute.
Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14)
Absolute Change in Body Weight
Time Frame: From Day 1 to Day 19
Body weight will be measured in kilograms (kg).
From Day 1 to Day 19
Percent Change in Body Weight
Time Frame: From Day 1 to Day 19
Body weight will be measured in kilograms (kg) and change will measured in %.
From Day 1 to Day 19
Change in Fasting Blood Samples for Fructosamine
Time Frame: From Day 2 to Day 19
Fructosamine is measured in umol/L
From Day 2 to Day 19
Change in Fasting Blood Samples for HA1c
Time Frame: From Day 2 to Day 19
HA1c is measured in %
From Day 2 to Day 19
Frequency of Adverse Events (AE) and Serious Adverse Events (SAE)
Time Frame: Days 1-21 and at 30 days post-intervention (Day 49).
Number of participants affected by probable drug-related adverse events.
Days 1-21 and at 30 days post-intervention (Day 49).

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Blood Oxygenation Level Response to Visual Opioid Drug Cues in Prefrontal Cortex Using Functional Near Infrared Spectroscopy (fNIRs)
Time Frame: Baseline (Day 1), end of the target drug dose (Day 19)
fNIRs indexes regional cerebral oxygenation saturation (%) by optical density (OD). Increased OD indicates increased blood oxygen saturation.
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)
Time Frame: Treatment (averaged across Days 2-19), Rebound follow up (averaged across Days 20-21)
Scores are measured on a 0-4 point VAS, where 0= no craving, 4= maximum craving. Treatment score is the average scores across Days 2-19. Rebound follow up score is the average scores across Days 20-21.
Treatment (averaged across Days 2-19), Rebound follow up (averaged across Days 20-21)
Rebound Change in Blood Pressure
Time Frame: From end of the target drug dose (Day 19) to rebound follow up (Day 21).
Blood pressure measurements in mmHg. Both pressures will be assessed during the study period.
From end of the target drug dose (Day 19) to rebound follow up (Day 21).
Rebound Change in Heart Rate
Time Frame: From end of the target drug dose (Day 19) to rebound follow up (Day 21).
Heart rate measurements in beats per minute
From end of the target drug dose (Day 19) to rebound follow up (Day 21).
Rebound Change in Respiratory Rate
Time Frame: From end of the target drug dose (Day 19) to rebound follow up (Day 21).
Respiratory rate in breaths per minutes.
From end of the target drug dose (Day 19) to rebound follow up (Day 21).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Milton S. Hershey Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)
National Institutes of Health (NIH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Scott Bunce, PhD, Milton S. Hershey Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 18, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 13, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 13, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 12, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 13559
  • 1UG3DA050325-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

Rare Diseases

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