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

NCT ID: NCT04199728

Last Updated: 2024-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-18
• Study Completion Date: 2023-09-13

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.

Conditions

Opiate Substitution Treatment; Opioid-Related Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Liraglutide Pen Injector

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo injection pen

Interventions

Liraglutide Pen Injector

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

Intervention Type: DRUG

Placebo

Placebo injection pen

Intervention Type: DRUG

Other Intervention Names

Saxenda

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 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Scott C Bunce, PhD

Associate Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Scott Bunce, PhD

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Locations

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39061093 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1UG3DA050325-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

13559

Identifier Type: -

Identifier Source: org_study_id