Evidence map›Paper›PMID 26659543›Full record

Trial reportBritish journal of clinical pharmacology2016

Pharmacokinetics and pharmacodynamics of γ-hydroxybutyrate in healthy subjects.

Matthias E Liechti, Boris B Quednow, Evangelia Liakoni, Dario Dornbierer, Robin von Rotz, Maria Salomé Gachet, Jürg Gertsch, Erich Seifritz, Oliver G Bosch

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

Trial report in British journal of clinical pharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
3.6field-weighted citation impact, top 7% 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

21 citing papers in PubMed, 54 citations in OpenAlex.

  1. Trial
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  5. Trial
  6. Gamma-Hydroxybutyrate Increases Resting-State Limbic Perfusion and Body and Emotion Awareness in Humans.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2017
    Trial
  7. Trial
  8. Review
  9. Review
  10. Characterization of the GHB Withdrawal Syndrome.Journal of clinical medicine · 2021
    Article
  11. Alcohol-Responsive Hyperkinetic Movement Disorders-a Mechanistic Hypothesis.Tremor and other hyperkinetic movements (New York, N.Y.) · 2020
    Review
  12. Review
  13. Review
  14. Article
  15. Article
  16. Article
  17. Review
  18. Article
  19. Review
  20. Presentations to an urban emergency department in Switzerland due to acute γ-hydroxybutyrate toxicity.Scandinavian journal of trauma, resuscitation and emergency medicine · 2016
    Article
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.

Matthias E LiechtiDivision of Clinical Pharmacology and Toxicology, Department of Biomedicine and Department of Clinical Research, University Hospital Basel, Βasel, CH-4031, Switzerland.
Boris B QuednowDepartment of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zurich, Lenggstrasse 31, Zurich, CH-8032, Switzerland.
Evangelia LiakoniDivision of Clinical Pharmacology and Toxicology, Department of Biomedicine and Department of Clinical Research, University Hospital Basel, Βasel, CH-4031, Switzerland.
Dario DornbiererDepartment of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zurich, Lenggstrasse 31, Zurich, CH-8032, Switzerland.
Robin von RotzDepartment of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zurich, Lenggstrasse 31, Zurich, CH-8032, Switzerland.
Maria Salomé GachetInstitute of Biochemistry and Molecular Medicine, University of Bern, Bühlstrasse 28, Bern, CH-3012, Switzerland.
Jürg GertschInstitute of Biochemistry and Molecular Medicine, University of Bern, Bühlstrasse 28, Bern, CH-3012, Switzerland.
Erich SeifritzDepartment of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zurich, Lenggstrasse 31, Zurich, CH-8032, Switzerland.
Oliver G BoschDepartment of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zurich, Lenggstrasse 31, Zurich, CH-8032, Switzerland.
University Hospital of Zurich · CHUniversity Hospital of Basel · CHUniversity of Bern · CHUniversity of Zurich · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsγ-Hydroxybutyrate (GHB) is used as a treatment for narcolepsy and alcohol withdrawal and as a recreational substance. Nevertheless, there are limited data on the pharmacokinetics and pharmacokinetic-pharmacodynamic relationships of GHB in humans. We characterized the pharmacokinetic profile and exposure-psychotropic effect relationship of GHB in humans.

methodsTwo oral doses of GHB (25 and 35 mg kg(-1) ) were administered to 32 healthy male subjects (16 for each dose) using a randomized, placebo-controlled, cross-over design.

resultsMaximal concentrations of GHB were (geometric mean and 95% CI): 218 (176-270) nmol ml(-1) and 453 (374-549) nmol ml(-1) for the 25 and 35 mg kg(-1) GHB doses, respectively. The elimination half-lives (mean ± SD) were 36 ± 9 and 39 ± 7 min and the AUC∞ values (geometric mean and 95% CI) were 15 747 (12 854-19 290) and 40 113 (33 093-48 622) nmol∙min ml(-1) for the 20 and 35 mg kg(-1) GHB doses, respectively. Thus, plasma GHB exposure (AUC0-∞ ) rose disproportionally (+40%) with the higher dose. γ-Hydroxybutyrate produced mixed stimulant-sedative effects, with a dose-dependent increase in sedation and dizziness. It did not alter heart rate or blood pressure. A close relationship between plasma GHB exposure and its psychotropic effects was found, with higher GHB concentrations associated with higher subjective stimulation, sedation, and dizziness. No clockwise hysteresis was observed in the GHB concentration effect plot over time (i.e., no acute pharmacological tolerance).

conclusionEvidence was found of a nonlinear dose-exposure relationship (i.e., no dose proportionality) at moderate doses of GHB. The effects of GHB on consciousness were closely linked to its plasma exposure and exhibited no acute tolerance.

Indexed as

Administration, OralAdultBlood PressureCross-Over StudiesDose-Response Relationship, DrugDrug ToleranceGABA AgonistsHealthy VolunteersHeart RateHumansHypnotics and SedativesMaleNarcolepsyPsychotropic DrugsSodium OxybateSubstance Withdrawal SyndromeGABA AgonistsHypnotics and SedativesPsychotropic DrugsSodium OxybateGHBliquid ecstasypharmacokineticsodium oxybate

Identifiers

PMID26659543
PMCPMC4834605
OpenAlexW2195705948

What OpenQuestion holds

Textmetadata
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.