Evidence map›Paper›PMID 39061093›Full record

ArticleAddiction science & clinical practice2024

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.

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 and 10 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Addiction science & clinical practice, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04199728 (Use of a GLP-1R Agonist to Treat Opioid Use Disorder), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04199728 phase1 / phase2completednot on this map

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

TypeinterventionalSponsorMilton S. Hershey Medical CenterRan2021 to 2023Enrolled27ConditionsOpiate Substitution Treatment, Opioid-Related DisordersArmsLiraglutide Pen Injector, Placebo
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Article
  5. Review
  6. Article
  7. Article
  8. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Christopher S FreetDepartment of Psychiatry and Behavioral Health, The Pennsylvania State University College of Medicine, Hershey, PA, USA.
Brianna EvansDepartment of Neural and Behavioral Sciences, The Pennsylvania State University College of Medicine, Hershey, PA, USA.
Timothy R BrickDepartment of Human Development and Family Studies, The Pennsylvania State University, University Park, PA, USA.
Erin DenekeFran and Doug Tieman Center for Research, Caron Treatment Centers, Wernersville, PA, USA.
Emily J WassermanDepartment of Public Health Sciences, The Pennsylvania State University College of Medicine, Hershey, PA, USA.
Sarah M BallardDepartment of Neural and Behavioral Sciences, The Pennsylvania State University College of Medicine, Hershey, PA, USA.
Dean M StankoskiFran and Doug Tieman Center for Research, Caron Treatment Centers, Wernersville, PA, USA.
Lan KongDepartment of Public Health Sciences, The Pennsylvania State University College of Medicine, Hershey, PA, USA.
Nazia Raja-KhanDepartment of Psychiatry and Behavioral Health, The Pennsylvania State University College of Medicine, Hershey, PA, USA.
Jennifer E NylandDepartment of Neural and Behavioral Sciences, The Pennsylvania State University College of Medicine, Hershey, PA, USA.
Amy C ArnoldDepartment of Neural and Behavioral Sciences, The Pennsylvania State University College of Medicine, Hershey, PA, USA.
Venkatesh Basappa KrishnamurthyDepartment of Medicine and Psychiatry, Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
Julio Fernandez-MendozaDepartment of Psychiatry and Behavioral Health, The Pennsylvania State University College of Medicine, Hershey, PA, USA.
H Harrington ClevelandDepartment of Human Development and Family Studies, The Pennsylvania State University, University Park, PA, USA.
Adam D ScioliFran and Doug Tieman Center for Research, Caron Treatment Centers, Wernersville, PA, USA.
Amanda MolchanowSynergy Pharmacy Services LLC, Norristown, PA, USA.
Amy E MessnerSynergy Pharmacy Services LLC, Norristown, PA, USA.
Hasan AyazSchool of Biomedical Engineering, Science and Health Systems, Drexel University, Philadelphia, PA, USA.
Patricia S GrigsonDepartment of Neural and Behavioral Sciences, The Pennsylvania State University College of Medicine, Hershey, PA, USA.
Scott C BunceDepartment of Psychiatry and Behavioral Health, The Pennsylvania State University College of Medicine, Hershey, PA, USA. sbunce@pennstatehealth.psu.edu.ORCID 0000-0002-1233-8709

Funding

Penn State Clinical and Translational Science InstituteUL1TR002014 · NCATS · PENNSYLVANIA STATE UNIV HERSHEY MED CTR · PI KRASCHNEWSKI, JENNIFER L. · 2016 to 2025
$33.7M
Use of a GLP-1 Agonist to Treat Opioid Use Disorder in Rats and ManUH3DA050325 · NIDA · PENNSYLVANIA STATE UNIV HERSHEY MED CTR · PI TIMOTHY R. BRICK, SCOTT C BUNCE · 2024 to 2026
$12.6M
Use of a GLP-1 Agonist to Treat Opioid Use Disorder in Rats and ManUG3DA050325 · NIDA · PENNSYLVANIA STATE UNIV HERSHEY MED CTR · PI BUNCE, SCOTT C, GRIGSON, PATRICIA SUE · 2019 to 2021
$5.4M
NCATS NIH HHS UL1 TR002014NIDA NIH HHS UG3 DA050325NIDA NIH HHS UG3DA050325NIDA NIH HHS UH3 DA050325Novo Nordisk ISS-Drug
6 · The paper itself

Abstract

backgroundDespite 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.

methodThis 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 registrationClinicalTrials.gov: NCT04199728. Registered 16 December 2019, https://clinicaltrials.gov/study/NCT04199728?term=NCT04199728 . PROTOCOL VERSION: 10 May 2023.

Indexed as

CravingEcological Momentary AssessmentGlucagon-Like Peptide-1 Receptor AgonistsLiraglutideOpioid-Related DisordersAdultCuesDouble-Blind MethodFemaleHumansMaleMiddle AgedRandomized Controlled Trials as TopicResidential TreatmentGlucagon-Like Peptide-1 Receptor AgonistsLiraglutideCravingEMAfNIRSFunctional near infrared spectroscopyGLP-1RAGlucagon-like peptide 1 receptor agonistLiraglutideSubstance use disorder

Identifiers

PMID39061093
PMCPMC11282646

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.