Evidence map›Paper›PMID 23934621›Full record

Trial reportJournal of clinical pharmacology2013

The effects of alcohol on the pharmacokinetics and pharmacodynamics of the selective mu-opioid receptor antagonist GSK1521498 in healthy subjects.

Hisham Ziauddeen, Pradeep J Nathan, Chris Dodds, Kay Maltby, Sam R Miller, Dawn Waterworth, Kijoung Song, Liling Warren, Louise Hosking, Mauro Zucchetto and 8 more

Open access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical pharmacology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 36% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Effect of alcohol on blood pressure.The Cochrane database of systematic reviews · 2020
    Pooled it
  2. Trial
  3. Addictive behaviour in experimental animals: prospects for translation.Philosophical transactions of the Royal Society of London. Series B, Biological sciences · 2018
    Review
  4. The Novel μ-Opioid Receptor Antagonist GSK1521498 Decreases Both Alcohol Seeking and Drinking: Evidence from a New Preclinical Model of Alcohol Seeking.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2015
    Article
  5. 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

18 authors at 6 institutions in 3 countries.

Hisham ZiauddeenMedicines Discovery and Development, GlaxoSmithKline, Clinical Unit Cambridge, Addenbrooke's Centre for Clinical Investigations, Cambridge, UK; Department of Psychiatry, Behavioural and Clinical Neuroscience Institute, Cambridge Biomedical Campus, University of Cambridge, Cambridge, UK; Metabolic Research Laboratories, Institute of Metabolic Science, University of Cambridge, Cambridge, UK; Cambridgeshire and Peterborough NHS Foundation Trust (CPFT), Cambridge, UK.
Pradeep J Nathan
Chris Dodds
Kay Maltby
Sam R Miller
Dawn Waterworth
Kijoung Song
Liling Warren
Louise Hosking
Mauro Zucchetto
Mark Bush
Lakshmi Vasist Johnson
Bhopinder Sarai
Karin Mogg
Brendan P Bradley
Duncan B Richards
Paul C Fletcher
Edward T Bullmore
GlaxoSmithKline (United Kingdom) · GBGlaxoSmithKline (United States) · USTriangle · USUniversity of Southampton · GBResearch Triangle Park Foundation · USUniversity of Cambridge · GB

Funding

Wellcome Trust 095692
6 · The paper itself

Abstract

The mu-opioid system has a key role in hedonic and motivational processes critical to substance addiction. However, existing mu-opioid antagonists have had limited success as anti-addiction treatments. GSK1521498 is a selective and potent mu-opioid antagonist being developed for the treatment of overeating and substance addictions. In this study, 28 healthy participants were administered single doses of GSK1521498 20 mg, ethanol 0.5 g/kg body weight, or both in combination, in a double blind placebo controlled four-way crossover design. The primary objective was to determine the risk of significant adverse pharmacodynamic and pharmacokinetic (PK) interactions. The effects of GSK1521498 on hedonic and consummatory responses to alcohol and the attentional processing of alcohol-related stimuli, and their modulation by the OPRM1 A118G polymorphism were also explored. GSK1521498 20 mg was well tolerated alone and in combination with ethanol. There were mild transient effects of GSK1521498 on alertness and mood that were greater when it was combined with ethanol. These effects were not of clinical significance. There were no effects of GSK1521498 on reaction time, hedonic or consummatory responses. These findings provide encouraging safety and PK data to support continued development of GSK1521498 for the treatment of alcohol addiction.

Indexed as

AdultAffectCross-Over StudiesDouble-Blind MethodDrug InteractionsEthanolHumansIndansMiddle AgedPolymorphism, GeneticReceptors, Opioid, muTriazolesYoung AdultEthanolIndansN-((3,5-difluoro-3'-(1H-1,2,4-triazol-3-yl)-4-biphenylyl)methyl)-2,3-dihydro-1H-inden-2-amineOPRM1 protein, humanReceptors, Opioid, muTriazolesaddictionalcoholmu-opioid receptorOPRM1pharmacodynamicspharmacogeneticspharmacokineticssafety

Identifiers

PMID23934621
PMCPMC4282435
OpenAlexW1498082644

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.