Evidence map›Paper›PMID 31557492›Full record

ArticleNeuropharmacology2020

Endocrine effects of the novel ghrelin receptor inverse agonist PF-5190457: Results from a placebo-controlled human laboratory alcohol co-administration study in heavy drinkers.

Mary R Lee, Mehdi Farokhnia, Enoch Cobbina, Anitha Saravanakumar, Xiaobai Li, Jillian T Battista, Lisa A Farinelli, Fatemeh Akhlaghi, Lorenzo Leggio

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase I
In one paragraph

Article in Neuropharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02039349 (A Novel Compound for Alcoholism Treatment), which is not on this map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
1.6field-weighted citation impact, top 18% of its field
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.

NCT02039349 phase1completednot on this map

A Novel Compound for Alcoholism Treatment: A Translational Strategy

TypeinterventionalSponsorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Ran2014 to 2017Enrolled14ConditionsAlcoholism, Alcohol-Related Disorders, Alcohol Dependence, Alcohol Drinking Related ProblemsArmsPF-05190457
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 citations in OpenAlex.

  1. Pooled it
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  13. The Role of Ghrelin/GHS-R1A Signaling in Nonalcohol Drug Addictions.International journal of molecular sciences · 2022
    Review
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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

9 authors at 4 institutions in 1 country.

Mary R LeeSection on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research and National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Bethesda, MD, USA.
Mehdi FarokhniaSection on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research and National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Bethesda, MD, USA; Center on Compulsive Behaviors, National Institutes of Health, Bethesda, MD, USA.
Enoch CobbinaClinical Pharmacokinetics Research Laboratory, Department of Biomedical & Pharmaceutical Sciences, College of Pharmacy, University of Rhode Island, Kingston, RI, USA.
Anitha SaravanakumarClinical Pharmacokinetics Research Laboratory, Department of Biomedical & Pharmaceutical Sciences, College of Pharmacy, University of Rhode Island, Kingston, RI, USA.
Xiaobai LiBiostatistics and Clinical Epidemiology Service, Clinical Center, National Institutes of Health, Bethesda, MD, USA.
Jillian T BattistaSection on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research and National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Bethesda, MD, USA.
Lisa A FarinelliSection on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research and National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Bethesda, MD, USA.
Fatemeh AkhlaghiClinical Pharmacokinetics Research Laboratory, Department of Biomedical & Pharmaceutical Sciences, College of Pharmacy, University of Rhode Island, Kingston, RI, USA.
Lorenzo LeggioSection on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research and National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Bethesda, MD, USA; Center on Compulsive Behaviors, National Institutes of Health, Bethesda, MD, USA; Medication Development Program, National Institute on Drug Abuse Intramural Research Program, National Institutes of Health, Baltimore, MD, USA; Center for Alcohol and Addiction Studies, Department of Behavioral and Social Sciences, Brown University, Providence, RI, USA. Electronic address: lorenzo.leggio@nih.gov.
National Institute on Drug Abuse · USUniversity of Rhode Island · USNational Institutes of Health · USNational Institutes of Health Clinical Center · US

Funding

Clinical Psychoneuroendocrinology and Neuropsychopharmacology (CPN)ZIAAA000218 · NIAAA · NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM · PI LEGGIO, LORENZO · 2013 to 2020
$22.8M
Clinical Psychoneuroendocrinology and Neuropsychopharmacology (CPN)ZIADA000635 · NIDA · NATIONAL INSTITUTE ON DRUG ABUSE · PI LEGGIO, LORENZO · 2020 to 2025
$15.2M
A Novel Compound for Alcoholism Treatment: a Translational StrategyUH3TR000963 · NCATS · UNIVERSITY OF RHODE ISLAND · PI AKHLAGHI, FATEMEH, LEGGIO, LORENZO · 2014 to 2016
$1.1M
A Novel Compound for Alcoholism Treatment: a Translational StrategyUH2TR000963 · NCATS · UNIVERSITY OF RHODE ISLAND · PI AKHLAGHI, FATEMEH, LEGGIO, LORENZO · 2013 to 2013
$550k
Translational Addiction MedicineZIADA000634 · NIDA · NATIONAL INSTITUTE ON DRUG ABUSE · PI LEGGIO, LORENZO · 2020 to 2021
$505k
Intramural NIH HHS ZIA AA000218NCATS NIH HHS UH2 TR000963NCATS NIH HHS UH3 TR000963
6 · The paper itself

Abstract

Both animal and human work suggests that the ghrelin system may be involved in the mechanisms that regulate the development and maintenance of alcohol use disorder. Previously, in a Phase 1b study, we tested pharmacological blockade of the growth hormone secretagogue receptor 1a (GHS-R1a, also known as the ghrelin receptor), in heavy drinking individuals with PF-5190457, an orally bioavailable, potent and selective GHS-R1a inverse agonist. We report here the effects of PF-5190457 on endocrine blood concentrations of amylin, gastric inhibitory polypeptide, glucagon-like peptide 1, insulin, leptin, pancreatic polypeptide, peptide YY, thyroid stimulating hormone, free triiodothyronine (T3), thyroxine (T4), cortisol, prolactin, and glucose during PF-5190457 dosing, as compared to placebo, in absence of alcohol as well as during an alcohol challenge when PF-5190457 was on steady-state. Blood hormone levels were largely unaffected by PF-5190457, both during dosing and in the context of alcohol challenge. The safety-related relevance of these findings to further develop PF-5190547 in alcohol use disorder is discussed. CLINICALTRIALS.GOV: NCT02039349. This article is part of the special issue on 'Neuropeptides'.

Indexed as

Drug Inverse AgonismAdultAlcoholic IntoxicationAzetidinesDose-Response Relationship, DrugEthanolFemaleGhrelinHormonesHumansIslet Amyloid PolypeptideLeptinMaleProlactinReceptors, GhrelinSingle-Blind MethodAzetidinesEthanolGhrelinHormonesIslet Amyloid PolypeptideLeptinPF-5190457ProlactinReceptors, GhrelinSpiro CompoundsAlcoholAlcohol use disorderGhrelinGHS-R1aHeavy drinkingHormonesNeuroendocrinologyPF-5190457

Identifiers

PMID31557492
PMCPMC7085971
OpenAlexW2977093108

What Socratic holds

Textmetadata
LicenceTDM
Read underepoch 390

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 Socratic graph.