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

Overview

Journal Addict Sci Clin Pract

Publisher Biomed Central

Specialty Psychiatry

Date 2024 Jul 26

PMID 39061093

Authors

Christopher S Freet

Brianna Evans

Timothy R Brick

Erin Deneke

Emily J Wasserman

Sarah M Ballard

Dean M Stankoski

Lan Kong

Nazia Raja-Khan

Jennifer E Nyland

Amy C Arnold

Venkatesh Basappa Krishnamurthy

Julio Fernandez-Mendoza

H Harrington Cleveland

Adam D Scioli

Amanda Molchanow

Amy E Messner

Hasan Ayaz

Patricia S Grigson

Scott C Bunce

Affiliations

Soon will be listed here.

Abstract

Background: Despite continuing advancements in treatments for opioid use disorder (OUD), continued high rates of relapse indicate the need for more effective approaches, including novel pharmacological interventions. Glucagon-like peptide 1 receptor agonists (GLP-1RA) provide a promising avenue as a non-opioid medication for the treatment of OUD. Whereas GLP-1RAs have shown promise as a treatment for alcohol and nicotine use disorders, to date, no controlled clinical trials have been conducted to determine if a GLP-1RA can reduce craving in individuals with OUD. The purpose of the current protocol was to evaluate the potential for a GLP-1RA, liraglutide, to safely and effectively reduce craving in an OUD population in residential treatment.

Method: This preliminary study was a randomized, double-blinded, placebo-controlled clinical trial designed to test the safety and efficacy of the GLP-1RA, liraglutide, in 40 participants in residential treatment for OUD. Along with taking a range of safety measures, efficacy for cue-induced craving was evaluated prior to (Day 1) and following (Day 19) treatment using a Visual Analogue Scale (VAS) in response to a cue reactivity task during functional near-infrared spectroscopy (fNIRS) and for craving. Efficacy of treatment for ambient craving was assessed using Ecological Momentary Assessment (EMA) prior to (Study Day 1), across (Study Days 2-19), and following (Study Days 20-21) residential treatment.

Discussion: This manuscript describes a protocol to collect clinical data on the safety and efficacy of a GLP-1RA, liraglutide, during residential treatment of persons with OUD, laying the groundwork for further evaluation in a larger, outpatient OUD population. Improved understanding of innovative, non-opioid based treatments for OUD will have the potential to inform community-based interventions and health policy, assist physicians and health care professionals in the treatment of persons with OUD, and to support individuals with OUD in their effort to live a healthy life.

Trial Registration: ClinicalTrials.gov: NCT04199728. Registered 16 December 2019, https://clinicaltrials.gov/study/NCT04199728?term=NCT04199728 .

Protocol Version: 10 May 2023.

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