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Opiate Substitution TreatmentPhase 1/2NCT04199728

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

A Phase 1/2 study testing Liraglutide Pen Injector in people with Opiate Substitution Treatment and Opioid-Related Disorders, run by Milton S. Hershey Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Liraglutide Pen Injector
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
27 participants
Where
1 siteUnited States
Study dates
18 Oct 2021to 13 Sep 2023
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033

Other trials in United States

About this study

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.

Read the 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.

Being tested
Liraglutide Pen Injector, Placebo
Keywords
Opiate treatment, Opioid treatment, Glucagon-Like Peptide-1 Agonist, Opioid use disorder, Liraglutide
Medical subject headings
Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Liraglutide Pen InjectorDrug

    Also called Saxenda

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

  • PlaceboDrug

    Placebo injection pen

Study groups in NCT04199728
Study groupRoleWhat they receive
Investigational groupExperimentalParticipants 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.
Receives: Drug: Liraglutide Pen Injector
Control groupPlacebo comparatorParticipants in the control group will have placebo administered by injection pen following the same low dose titration to 3.0 mg once per day.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline (Day 1), End of the target drug dose (Day 19)

  2. 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.

    Measured: Baseline (Day 1), Treatment Days (Days 2-19)

Secondary outcomes (8)

  1. Change in Blood Pressure

    Blood pressure measurements in mmHg. Both systolic and diastolic pressures will be assessed during the study period.

    Measured: Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14)

  2. Change in Heart Rate

    Heart rate measurements in beats per minute.

    Measured: Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14)

  3. Change in Respiratory Rate

    Respiratory rate in breaths per minute.

    Measured: Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14)

  4. Absolute Change in Body Weight

    Body weight will be measured in kilograms (kg).

    Measured: From Day 1 to Day 19

  5. Percent Change in Body Weight

    Body weight will be measured in kilograms (kg) and change will measured in %.

    Measured: From Day 1 to Day 19

  6. Change in Fasting Blood Samples for Fructosamine

    Fructosamine is measured in umol/L

    Measured: From Day 2 to Day 19

  7. Change in Fasting Blood Samples for HA1c

    HA1c is measured in %

    Measured: From Day 2 to Day 19

  8. Frequency of Adverse Events (AE) and Serious Adverse Events (SAE)

    Number of participants affected by probable drug-related adverse events.

    Measured: Days 1-21 and at 30 days post-intervention (Day 49).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2019
  2. Study start18 Oct 2021
  3. Primary completion13 Sep 2023
  4. Study completion13 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04199728
Sponsor's protocol ID
13559
Other IDs
1UG3DA050325-01
Status last verified
Nov 2024
First submitted
12 Dec 2019
Last updated
6 Nov 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39061093

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Liraglutide Pen Injector in people with Opiate Substitution Treatment and Opioid-Related Disorders, run by Milton S. Hershey Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04199728, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2024.

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