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Trial · Interventional

CompletedPhase 1/2Results postedRegistry data

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

NCTNCT04199728 (opens ClinicalTrials.gov in a new tab)Other id13559Other id1UG3DA050325-01

Overview

Status
Completed
Phase
Phase 1/2
Enrollment
27 participants (actual)
Sponsor
Milton S. Hershey Medical Center · Other
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
18 Oct 2021
Primary completion
13 Sept 2023
Completion
13 Sept 2023
First posted
16 Dec 2019
Last update posted
6 Nov 2024
Conditions
Opiate Substitution Treatment · Opioid-Related Disorders

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2021202220232024
  1. Ph 1/2

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

    NCT04199728

    18 Oct 2021 to 13 Sept 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Liraglutide Pen InjectorDrug
  • PlaceboDrug

Arms2

  • 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.

  • 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.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. 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)

    Registry description

    Scores are measured on a 0-100 point VAS, where 0= no craving, 100= maximum craving.

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

    Time frame · Baseline (Day 1), Treatment Days (Days 2-19)

    Registry description

    Scores are measured on a 0-4 point VAS, where 0= no craving, 4= maximum craving.

Secondary outcomes(8)
  1. Change in Blood Pressure

    Time frame · Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14)

    Registry description

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

  2. Change in Heart Rate

    Time frame · Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14)

    Registry description

    Heart rate measurements in beats per minute.

  3. Change in Respiratory Rate

    Time frame · Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14)

    Registry description

    Respiratory rate in breaths per minute.

  4. Absolute Change in Body Weight

    Time frame · From Day 1 to Day 19

    Registry description

    Body weight will be measured in kilograms (kg).

  5. Percent Change in Body Weight

    Time frame · From Day 1 to Day 19

    Registry description

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

  6. Change in Fasting Blood Samples for Fructosamine

    Time frame · From Day 2 to Day 19

    Registry description

    Fructosamine is measured in umol/L

  7. Change in Fasting Blood Samples for HA1c

    Time frame · From Day 2 to Day 19

    Registry description

    HA1c is measured in %

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

    Time frame · Days 1-21 and at 30 days post-intervention (Day 49).

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline (Day 1), End of the target drug dose (Day 19)

Change in Self-reported Cue-elicited Drug Craving as Measured by Visual Analog Scale (VAS)

GroupValue (score on a scale)Spread
Investigational Group-5.00NA
Control Group-13.3419.58
Primary outcomeMean· Baseline (Day 1), Treatment Days (Days 2-19)

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

GroupValue (score on a scale)Spread
Investigational Group-0.55NA
Control Group-1.410.99
Secondary and other outcome results(6)
Secondary outcomeMean· Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14)

Change in Blood Pressure

GroupValue (mmHg)Spread
Investigational Group4.00NA
Control Group-0.594.69
Secondary outcomeMean· Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14)

Change in Heart Rate

GroupValue (beats per minute)Spread
Investigational Group10.75NA
Control Group-5.785.10
Secondary outcomeMean· Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14)

Change in Respiratory Rate

GroupValue (breaths per minute)Spread
Investigational Group-1.00NA
Control Group0.082.83
Secondary outcomeMean· From Day 1 to Day 19

Absolute Change in Body Weight

GroupValue (kg)Spread
Investigational Group0.27NA
Control Group1.051.86
Secondary outcomeMean· From Day 1 to Day 19

Percent Change in Body Weight

GroupValue (% change)Spread
Investigational Group0.33NA
Control Group1.382.39
Secondary outcomeMean· From Day 2 to Day 19

Change in Fasting Blood Samples for Fructosamine

GroupValue (umol/L)Spread
Investigational Group-14.00NA
Control Group2.7121.48

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Investigational GroupParticipants 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. Liraglutide Pen Injector: Liraglutide will be provided using an injection pen provided by the manufacturer0 / 122 / 1210 / 12
Control GroupParticipants in the control group will have placebo administered by injection pen following the same low dose titration to 3.0 mg once per day. Placebo: Placebo injection pen0 / 131 / 138 / 13

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

0 studies on this page

Indexing hint: Clinical trial · 2024

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.

Freet et al. 2024Addiction science & clinical practicecited by 18

PMID 39061093PMC11282646DOI 10.1186/s13722-024-00481-7PUB-39061093

CC BY
Download PDF

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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