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Expert Opinion on Investigational Drugs Volume 18, 2009 - Issue 5
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Drug Evaluations

The therapeutic potential of gamma-hydroxybutyric acid for alcohol dependence: balancing the risks and benefits. A focus on clinical data

Giovanni Addolorato Catholic University of Rome, Institute of Internal Medicine, L.o A. Gemelli 8, I-00168 Rome, Italy +39 06 3015 4334; +39 06 3550 2775; [email protected]
, MD,
Lorenzo Leggio Catholic University of Rome, Institute of Internal Medicine, L.o A. Gemelli 8, I-00168 Rome, Italy +39 06 3015 4334; +39 06 3550 2775; [email protected]; Brown University Medical School, Center for Alcohol and Addiction Studies, Providence (RI), USA
, MD MSc,
Anna Ferrulli Catholic University of Rome, Institute of Internal Medicine, L.o A. Gemelli 8, I-00168 Rome, Italy +39 06 3015 4334; +39 06 3550 2775; [email protected]
, MD,
Fabio Caputo SS Annunziata Hospital, Department of Internal Medicine, Cento (FE), Italy
, MD PhD &
Antonio Gasbarrini Catholic University of Rome, Medical Pathology, Rome, Italy
, MD
Pages 675-686 | Published online: 21 Apr 2009

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Giovanni Addolorato, Otto-Michael Lesch, Icro Maremmani, Henriette Walter, Felice Nava, Quentin Raffaillac & Fabio Caputo. (2020) Post-marketing and clinical safety experience with sodium oxybate for the treatment of alcohol withdrawal syndrome and maintenance of abstinence in alcohol-dependent subjects. Expert Opinion on Drug Safety 19:2, pages 159-166.
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Mariangela Antonelli, Anna Ferrulli, Luisa Sestito, Gabriele A. Vassallo, Claudia Tarli, Carolina Mosoni, Maria M. Rando, Antonio Mirijello, Antonio Gasbarrini & Giovanni Addolorato. (2018) Alcohol addiction - the safety of available approved treatment options. Expert Opinion on Drug Safety 17:2, pages 169-177.
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Katrin Skala, Fabio Caputo, Antonio Mirijello, Gabriele Vassallo, Mariangela Antonelli, Anna Ferrulli, Henriette Walter, Otto Lesch & Giovanni Addolorato. (2014) Sodium oxybate in the treatment of alcohol dependence: from the alcohol withdrawal syndrome to the alcohol relapse prevention. Expert Opinion on Pharmacotherapy 15:2, pages 245-257.
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Jenny L. Wilkerson, Takato Hiranita, Wouter Koek & Lance R. McMahon. (2022) The discriminative stimulus effects of baclofen and gamma hydroxybutyrate in C57BL/6J mice. Behavioural Pharmacology 33:6, pages 427-434.
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Claudia Tarli, Antonio Mirijello & Giovanni Addolorato. (2022) Treating Alcohol Use Disorder in Patients with Alcohol-Associated Liver Disease: Controversies in Pharmacological Therapy. Seminars in Liver Disease 42:02, pages 138-150.
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Julien Guiraud, Giovanni Addolorato, Henri-Jean Aubin, Philippe Batel, Andrea de Bejczy, Fabio Caputo, Anna E. Goudriaan, Antoni Gual, Otto Lesch, Icro Maremmani, Pascal Perney, Roch Poulnais, Quentin Raffaillac, Bo Soderpalm, Rainer Spanagel, Henriette Walter & Wim van den Brink. (2021) Treating alcohol dependence with an abuse and misuse deterrent formulation of sodium oxybate: Results of a randomised, double-blind, placebo-controlled study. European Neuropsychopharmacology 52, pages 18-30.
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Louise Thiesen, Bente Frølund & Petrine Wellendorph. (2019) Lack of evidence for synaptic high‐affinity γ‐hydroxybutyric acid ( GHB ) transport in rat brain synaptosomes and 11 Na + ‐dependent SLC neurotransmitter transporters . Journal of Neurochemistry 149:2, pages 195-210.
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Hyeon-Seong Lee, Chan Seo, Young-A Kim, Meejung Park, Boyeon Choi, Moongi Ji, Sooyeun Lee & Man-Jeong Paik. (2019) Metabolomic study of polyamines in rat urine following intraperitoneal injection of γ-hydroxybutyric acid. Metabolomics 15:4.
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Mark Thursz, Antoni Gual, Caroline Lackner, Philippe Mathurin, Christophe Moreno, Laurent Spahr, Martina Sterneck & Helena Cortez-Pinto. (2018) EASL Clinical Practice Guidelines: Management of alcohol-related liver disease. Journal of Hepatology 69:1, pages 154-181.
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Harmen Beurmanjer, Rama M. Kamal, Cor A. J. de Jong, Boukje A. G. Dijkstra & Arnt F. A. Schellekens. (2018) Baclofen to Prevent Relapse in Gamma-Hydroxybutyrate (GHB)-Dependent Patients: A Multicentre, Open-Label, Non-Randomized, Controlled Trial. CNS Drugs 32:5, pages 437-442.
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Jacob Krall, Claus Hatt Jensen, Francesco Bavo, Christina Birkedahl Falk-Petersen, Anne Stæhr Haugaard, Stine Byskov Vogensen, Yongsong Tian, Mia Nittegaard-Nielsen, Sara Björk Sigurdardóttir, Jan Kehler, Kenneth Thermann Kongstad, David E. Gloriam, Rasmus Prætorius Clausen, Kasper Harpsøe, Petrine Wellendorph & Bente Frølund. (2017) Molecular Hybridization of Potent and Selective γ-Hydroxybutyric Acid (GHB) Ligands: Design, Synthesis, Binding Studies, and Molecular Modeling of Novel 3-Hydroxycyclopent-1-enecarboxylic Acid (HOCPCA) and trans -γ-Hydroxycrotonic Acid (T-HCA) Analogs . Journal of Medicinal Chemistry 60:21, pages 9022-9039.
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Giovanni Addolorato, Antonio Mirijello, Pablo Barrio & Antoni Gual. (2016) Treatment of alcohol use disorders in patients with alcoholic liver disease. Journal of Hepatology 65:3, pages 618-630.
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Rama M. Kamal, Boukje A.G. Dijkstra, Anton J. Loonen & Cornelis A.J. De Jong. (2016) The Effect of Co-occurring Substance Use on Gamma-hydroxybutyric Acid Withdrawal Syndrome. Journal of Addiction Medicine 10:4, pages 229-235.
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Fabio Caputo, Angelo GI Maremmani, Giovanni Addolorato, Marco Domenicali, Giorgio Zoli, Antonio D’Amore, Icro Maremmani & Mauro Bernardi. (2016) Sodium oxybate plus nalmefene for the treatment of alcohol use disorder: A case series. Journal of Psychopharmacology 30:4, pages 402-409.
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Boris B. Quednow & Marcus Herdener. 2016. Neuroscience for Addiction Medicine: From Prevention to Rehabilitation - Methods and Interventions. Neuroscience for Addiction Medicine: From Prevention to Rehabilitation - Methods and Interventions 227 250 .
Rama M Kamal, Arnt Schellekens, Cornelis AJ De Jong & Boukje AG Dijkstra. (2015) Baclofen as relapse prevention in the treatment of Gamma- Hydroxybutyrate (GHB) dependence: an open label study. BMC Psychiatry 15:1.
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Angelo G.I. Maremmani, Silvia Bacciardi, Luca Rovai, Fabio Rugani, Liliana Dell’Osso & Icro Maremmani. (2015) Sodium Oxybate as Off-label Treatment for Anxiety Disorder. Addictive Disorders & Their Treatment 14:4, pages 198-202.
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Nathalie Pross, Alain Patat, Philippe Vivet, Michelle Bidaut & Nicolas Fauchoux. (2015) Pharmacodynamic interactions of a solid formulation of sodium oxybate and ethanol in healthy volunteers. British Journal of Clinical Pharmacology 80:3, pages 480-492.
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Louise Thiesen, Jan Kehler, Rasmus P. Clausen, Bente Frølund, Christoffer Bundgaard & Petrine Wellendorph. (2015) In Vitro and In Vivo Evidence for Active Brain Uptake of the GHB Analog HOCPCA by the Monocarboxylate Transporter Subtype 1. Journal of Pharmacology and Experimental Therapeutics 354:2, pages 166-174.
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Ann-Sophie Korb & Gail Cooper. (2014) Endogenous Concentrations of GHB in Postmortem Blood from Deaths Unrelated to GHB Use. Journal of Analytical Toxicology 38:8, pages 582-588.
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Rama Kamal & Mary Janssen van Raay. (2014) Wat is gammahydroxyboterzuur (GHB)?. Verslaving 10:3, pages 5-16.
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Jennifer Casanova & Ramón Bataller. (2014) Alcoholic hepatitis: Prognosis and treatment. Gastroenterología y Hepatología 37:4, pages 262-268.
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Carolina L. Haass-Koffler, Lorenzo Leggio & George A. Kenna. (2014) Pharmacological Approaches to Reducing Craving in Patients with Alcohol Use Disorders. CNS Drugs 28:4, pages 343-360.
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Fabio Caputo & Mauro Bernardi. (2013) Sodium oxybate to treat alcohol dependence: 20 years of clinical experience. Addiction Biology 18:6, pages 901-903.
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