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

NCT04199728 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: 135591UG3DA050325-01
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Opiate Substitution Treatment; Opioid-Related Disorders

Keywords

Opiate treatment; Opioid treatment; Glucagon-Like Peptide-1 Agonist; Opioid use disorder; Liraglutide

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

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).

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 Injector DRUG

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

Also known as: Saxenda

Investigational group

Placebo DRUG

Placebo injection pen

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

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: 39061093 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

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

sbunce@pennstatehealth.psu.edu

215-510-8295

Study Officials

• Scott Bunce, PhD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• 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
• Primary Completion: September 13, 2023
• Study Completion: September 13, 2023
• Last Updated: November 6, 2024
• Results First Posted: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)