Sodium oxybate in the treatment of alcohol dependence: From the alcohol withdrawal syndrome to the alcohol relapse prevention

Expert Opinion on Pharmacotherapy

Volumn 15, Issue 2, 2014, Pages 245-257

  Skala, Katrin ^a   Caputo, Fabio ^b,c   Mirijello, Antonio ^d   Vassallo, Gabriele ^d   Antonelli, Mariangela ^d   Ferrulli, Anna ^d   Walter, Henriette ^a   Lesch, Otto ^a   Addolorato, Giovanni ^d  

^a MEDICAL UNIVERSITY OF VIENNA   (Austria)

^b Division of Endocrinology and Metabolism   (Italy)

^c UNIVERSITY OF BOLOGNA   (Italy)

^d FONDAZIONE POLICLINICO UNIVERSITARIO A GEMELLI IRCCS   (Italy)

Author keywords

Alcoholism; Gamma hydroxybutyric acid; GHB; SMO

Indexed keywords

ALCOHOL; OXYBATE SODIUM;

ALCOHOL ABSTINENCE; ALCOHOL ABUSE; ALCOHOL CONSUMPTION; ALCOHOL WITHDRAWAL; ALCOHOLISM; ARTICLE; CHEMOPROPHYLAXIS; DEPENDENT PERSONALITY DISORDER; DRUG COMBINATION; DRUG COMPARISON; DRUG EFFICACY; DRUG METABOLISM; DRUG SAFETY; HUMAN; NEUROMODULATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); RELAPSE; RISK ASSESSMENT; RISK FACTOR;

ALCOHOL DRINKING; ALCOHOLISM; ANIMALS; DRUG APPROVAL; HUMANS; RECURRENCE; SODIUM OXYBATE; SUBSTANCE WITHDRAWAL SYNDROME; TEMPERANCE; TREATMENT OUTCOME;

EID: 84892185974     PISSN: 14656566     EISSN: 17447666     Source Type: Journal    
DOI: 10.1517/14656566.2014.863278     Document Type: Article

References (91)

1. Schuckit MA. Alcohol-use disorders. Lancet 2009;37:492-501
2. Rehm J, Mathers C, Popova S, et al. Global burden of disease and injury and economic cost attributable to alcohol use and alcohol-use disorders. Lancet 2009;373:2223-33
3. Lim SS, Vos T, Flaxman AD, et al. A comparative risk assessment of burden of disease and injury attributable to 67 risk factors and risk factor clusters in 21 regions, 1990-2010: a systematic analysis for the Global Burden of Disease Study, 2010. Lancet 2012;380:2224-60
4. Friedmann PD. Alcohol use in adults. New Engl J Med 2013;368:365-73
5. Suh JJ, Pettinati HM, Kampman KM, et al. The status of disulfiram: a half of a century later. J Psychopharmacol 2006;26:290-302
6. Rosner S, Hackl-errwerth A, Leucht S, et al. Opioid antagonists for alcohol dependence. Cochrane Database Syst Rev 2010;8:CD001867
7. Rosner S, Hackl-Herrwerth A, Leucht S, et al. Acamprosate for alcohol dependence. Cochrane Database Syst Rev 2010;8:CD004332
8. van den Brink W, Aubin HJ, Bladstrom A, et al. Efficacy of as-needed nalmefene in alcohol-dependent patients with at least a high drinking risk level: results from a subgroup analysis of two randomized controlled 6-month studies. Alcohol Alcohol 2013;48:570-8
9. Addolorato G, Mirijello A, Leggio L. Alcohol addiction: towards a patientoriented pharmacological treatment. Expert Opin Pharmacother 2013; [Epub ahead of print]
10. Snead OC, Gibson KM. Gamma-hydroxybutyric acid. N Engl J Med 2005;352:2721-32
11. Palatini P, Tedeschi L, Frison G, et al. Dose-dependent absorption and elimination of gamma-hydroxybutyric acid in healthy volunteers. Eur J Clin Pharmacol 1993;45:353-6
12. Carter LP, Koek W, France CP. Behavioral analyses of GHB: receptor mechanisms. Pharmacol Ther 2009;121:100-4
13. Absalom N, Eghorn LF, Villumsen IS, et al. alpha4betadelta GABA(A) receptors are high-Affinity targets for gammahydroxybutyric acid (GHB). Proc Natl Acad Sci USA 2012;109:13404-9
14. Bessmann SP, Fishbein WM. Gamma-hydroxybutyric acid, a normal brain metabolite. Nature 1963;200:1207-8
15. Laborit H, Jouany JM, Gerard J, Fabiani F. Summary of an experimental and clinical study on a metabolic substrate with inhibitory central action: sodium 4-hydroxybutyrate. Presse Med 1960;68:1867-9
16. Aldrete JA, Barnes DP. 4-hydroxybutyrate anaesthesia for cardiovascular surgery. A comparison with halothane. Anaesthesia 1968;23:558-65
17. Kleinschmidt S, Grundmann U, Janneck U, et al. Total intravenous anaesthesia using propofol, gammahydroxybutyrate or midazolam in combination with sufentanil for patients undergoing coronary artery bypass surgery. Eur J Anaesthesiol 1997;14:590-9
18. Kleinschmidt S, Grundmann U, Knocke T, et al. Total intravenous anaesthesia with gamma-hydroxybutyrate (GHB) and sufentanil in patients undergoing coronary artery bypass graft surgery: a comparison in patients with unimpaired and impaired left ventricular function. Eur J Anaesthesiol 1998;15:559-64
19. Mamelak M, Escriu JM, Stokan O. The effects of gamma-hydroxybutyrate on sleep. Biol Psychiatry 1977;2:273-88
20. Mamelak M, Scharf MB, Woods M. Treatment of narcolepsy with gammahydroxybutyrate. A review of clinical and sleep laboratory findings. Sleep 1986;9:285-9
21. Broughton R, Mamelak M. Effects of nocturnal gamma-hydroxybutyrate on sleep/waking patterns in narcolepsy-cataplexy. Can J Neurol Sci 1980;7:23-31
22. Fiellin DA, OConnor PG, Holmboe ES, Horwitz RI. Risk for delirium tremens in patients with alcohol withdrawal syndrome. Subst Abuse 2002;23:83-94
23. OConnor PG, Schottenfeld RS. Patients with alcohol problems. N Engl J Med 1998;338:592-602
24. Mayo-Smith MF. Pharmacological management of alcohol withdrawal: a meta-Analysis and evidence-based practice guideline: american Society of Addiction Medicine Working Group on Pharmacological Management of Alcohol Withdrawal. JAMA 1997;278:144-51
25. Leggio L, Kenna GA, Swift RM. New developments for the pharmacological treatment of alcohol withdrawal syndrome. A focus on nonbenzodiazepine GABAergic medications. Prog Neuropsychopharmacol Biol Psychiatry 2008;32(5):1106-17
26. Gessa GL, Agabio R, Carai M, et al. Mechanism of the anti-Alcohol effect of gamma hydroxybutyric acid (GHB). Alcohol 2000;20:271-6
27. Fadda F, Colombo G, Mosca E, Gessa GL. Suppression by gammahydroxybutyric acid of ethanol withdrawal syndrome in rats. Alcohol Alcohol 1989;24:447-51
28. Gallimberti L, Canton G, Gentile N, et al. Gamma-hydroxybutyric acid for the treatment of alcohol withdrawal syndrome. Lancet 1989;2:787-9
29. Addolorato G, Balducci G, Capristo E, et al. Gamma-hydroxybutyric acid (GHB) in the treatment of alcohol withdrawal syndrome: a randomized comparative study versus benzodiazepine. Alcohol Clin Exp Res 1999;23:1596-604
30. Nava F, Premi S, Manzato E, et al. Gamma-hydroxybutyrate reduces both withdrawal syndrome and hypercortisolism in severe abstinent alcoholics: an open study vs. diazepam. Am J Drug Alcohol Abuse 2007;33:379-92
31. Nimmerrichter AA, Walter H, Gutierrez-Lobos KE, Lesch OM. Double blind controlled trial of gamma-hydroxybutyrate and clomethiazole in the treatment of alcohol withdrawal. Alcohol Alcohol 2002;37:67-73
32. Sullivan JT, Sykora K, Schniederman J, et al. Assessment of alcohol withdrawal: the revised clinical institute withdrawal assessment for alcohol scale (CIWA-Ar). Br J Addict 1989;84:1353-7
33. Elsing C, Stremmel W, Grenda U, Herrmann T. Gamma-hydroxybutyric acid versus clomethiazole for the treatment of alcohol withdrawal syndrome in a medical intensive care unit: an open, single-center randomized study. Am J Drug Alcohol Abuse 2009;35(3):189-92
34. Leone MA, Vigna-Taglianti F, Avanzi GC, et al. Gamma-hydroxybutyrate (GHB) for treatment of alcohol withdrawal and prevention of relapses. Cochrane Database Syst Rev 2010(2):CD006266
35. Ungur LA, Neuner B, John S, et al. Prevention and therapy of alcohol withdrawal on intensive care units: systematic review of controlled trials. Alcohol Clin Exp Res 2013;37(4):675-86
36. Agabio R, Colombo G, Loche A, et al. Gamma-hydroxybutyric acid reducing effect on ethanol intake: evidence in favour of a substitution mechanism. Alcohol Alcohol 1998;33:465-74
37. Colombo G, Agabio R, Lobina C, et al. Cross tolerance to ethanol and gammahydroxybutyric acid. Eur J Pharmacol 1995;273:235-8
38. Gessa GL, Agabio R, Carai MA, et al. Mechanism of the anti-Alcohol effect of gamma-hydroxybutyric acid. Alcohol 2000;20:271-6
39. Biggio G, Cibin M, Diana M, et al. Suppression of voluntary ethanol intake in rats and alcoholics by gammahydroxybutyric acid: a non-GABAergic mechanism. Adv Biochem Psychopharmacol 1992;47:281-8
40. Gallimberti L, Ferri M, Ferrara SD, et al. Gamma-hydroxybutyric acid in the treatment of alcohol dependence: a double-blind study. Alcohol Clin Exp Res 1992;16:673-6
41. Addolorato G, Castelli E, Stefanini GF, et al. An open multicentric study evaluating 4-hydroxybutyric acid sodium salt in the medium-term treatment of 179 alcohol-dependent subjects. GHB Study Group. Alcohol Alcohol 1996;31:341-5
42. Palatini P, Tedeschi L, Frison G, et al. Dose-dependent absorption and elimination of gamma-hydroxybutyric acid in healthy volunteers. Eur J Clin Pharmacol 1993;45:353-6
43. Ferrara SD, Zotti S, Tedeschi L, et al. Pharmacokinetics of gammahydroxybutyric acid in alcohol dependent patients after single and repeated oral doses. Br J Clin Pharmacol 1992;34:231-5
44. Addolorato G, Cibin M, Caputo F, et al. Gamma-hydroxybutyric acid in the treatment of alcoholism: dosage fractioning utility in non-responder alcoholic patients. Drug Alcohol Depend 1998;53:7-10
45. Maremmani I, La Manna F, Tagliamone A. Long-term therapy using GHB (sodium gamma-hydroxybutyrate) for treatment-resistant chronic alcoholics. J Psychoactive Drug 2001;33:135-42
46. Thai D, Dyer JE, Benowitz NL, Haller CA. Gamma-hydroxybutyrate and ethanol effects and interactions in humans. J Clin Psychopharmacol 2006;26:524-9
47. Vivet P, Pross N, Denot C, et al. Pharmacodynamic interactions of a solid formulation of sodium oxybate and alcohol in healthy volunteers. Alcohol Alcohol 2013;48:S1-i34
48. Caputo F, Addolorato G, Lorenzini F, et al. Gamma-hydroxybutyric acid versus naltrexone in maintaining alcohol abstinence: an open randomized comparative study. Drug Alcohol Depend 2003;70:85-91
49. Caputo F, Addolorato G, Stoppo M, et al. Comparing and combining gammahydroxybutyric acid (GHB) and naltrexone in maintaining abstinence from alcohol: an open randomised comparative study. Eur Neuropsychopharmacol 2007;17:781-9
50. Caputo F, Stoppo M, Vignoli T, et al. Use of alcohol during the treatment of alcohol dependence with gamma-Hydroxybutyric Acid: risk of severe events are avoided by the dose fractioning of the drug. J Clin Psychopharmacol 2007;27:418
51. Caputo F, Skala K, Walter H, et al. Sodium Oxybate in the prevention of alcohol relapses in alcohol dependent patients (GATE 2 study). Alcohol Alcohol 2013;48:S1-i33
52. Cacciaglia R, Lesch OM, Vivet P. GATE 2 Study: sodium oxybate in the maintainance of alcohol abstinence and prevention of alcohol relapse. Alcohol Alcohol 2013;48:S1-i47
53. Pombo S, Lesch OM. The alcoholic phenotypes among different multidimensional typologies: similarities and their classification procedures. Alcohol Alcohol 2009;44:46-54
54. Lesch OM, Kefer J, Lentner S, et al. The course of alcoholism. Long termprognosis in different subtypes. Forensic Sci Int 1988;36:121-38
55. Anton RF, OMalley SS, Ciraulo DA, et al. Combine Study Research Group (2006) Combine pharmacotherapies and behavioural intervention for alcohol dependence: the COMBINE study: a randomized controlled study. JAMA 2006;295:2003-17
56. Nava F, Premi S, Manzato E, et al. Comparing treatments of alcoholism on craving and bio-chemical measures of alcohol consumptions. J Psychoactive Drug 2006;38:211-17
57. Caputo F, Vignoli T, Lorenzini F, et al. Suppression of craving for gamma-hydroxybutyric acid by naltrexone administration: three case reports. Clin Neuropharmacol 2005;28:87-9
58. Stella L, Addolorato G, Rinaldi B, et al. An open randomized study of the treatment of escitalopram alone and combined with gamma-hydroxybutyric acid and naltrexone in alcoholic patients. Pharmacol Res 2008;57:312-17
59. Verheul R, Van Den Brink W, Geerlings P. A three-pathway psychological model of craving for alcohol. Alcohol Alcohol 1999;34:197-222
60. Addolorato G, Abenavoli L, Leggio L, Gasbarrini G. How many cravings? Pharmacological aspects of craving treatment in alcohol addiction: a review. Neuropsychobiology 2005;51:59-66
61. Leggio L, Kenna GA, Fenton M, et al. Typologies of alcohol dependence from Jellinek to genetics and beyond. Neuropsychol Rev 2009;19(1):115-29
62. Maremmani AG, Pani PP, Rovai L, et al. Long-term gamma-hydroxybutyric acid (GHB) and disulfiram combination therapy in GHB treatment-resistant chronic alcoholics. Int J Environ Res Public Health 2011;8:2816-27
63. Wong CGT, Gibson KM, Snead OC. From the street to the brain: neurobiology of the recreational drug gamma-hydroxybutyric acid. Trends Pharmacol Sci 2004;25:29-34
64. Addolorato G, Caputo F, Capristo E, et al. Gamma-hydroxybutyric acid efficacy, potential of abuse, and dependence in the treatment of alcohol addiction. Alcohol 2000;20:217-22
65. Addolorato G, Leggio L, Ferrulli A, et al. The therapeutic potential of gammahydroxybutyric acid for alcohol dependence: balancing the risks and benefits. A focus on clinical data. Expert Opin Investig Drugs 2009;18(5):675-86
66. Tunnicliff G. Site of action of Gammahydroxybutyrate (GHB) -A neuroactive drug with abuse potential. J Toxicol Clin Toxicol 1997;35:581-90
67. Nicholson KL, Balster RL. GHB: a new and novel drug of abuse. Drug Alcohol Depend 2000;63:1-22
68. Drasbek KR, Christensen J, Jensen K. Gamma-hydroxybutyrate -A drug of abuse. Acta Neurol Scand 2006;114:145-56
69. Friedman J, Westlake R, Furman M. Grievous bodily harm: gamma hydroxybutyrate abuse leading to the Wernicke-Korsakoff syndrome. Neurology 1996;46:469-71
70. Addolorato G, Capristo E, Gessa GL, et al. Long-term administration of GHB does not affect muscular mass in alcoholics. Life Sci 1999;65:191-6
71. Korf DJ, Nabben T, Benschop A, et al. Risk factors of gamma-hydroxybutyrate overdosing. Eur Addict res 2014;20:66-74
72. Liechti ME, Kunz I, Greminger P, et al. Clinical features of gammahydroxybutyrate and gammabutyrolactone toxicity and concomitant drug and alcohol use. Drug Alcohol Depend 2006;81:323-6
73. Sumnall HR, Woolfall K, Edwards S, et al. Use, function, and subjective experiences of gamma-hydroxybutyrate (GHB). Drug Alcohol Depend 2008;92:286-90
74. Dyer J. Gamma-hydroxybutyrate: a health food product producing coma and seizure-like activity. Am J Emerg Med 1991;9:321-4
75. Van Amsterdam JG, Brunt TM, McMaster MT, Niesink RJ. Possible long-term effects of gammahydroxybutyric acid (GHB) due to neurotoxicity and overdose. Neurosci Biobehav Rev 2012;36:1217-27
76. Addolorato G, Caputo F, Capristo E, et al. A case of gamma-hydroxybutyric acid withdrawal syndrome during alcohol addiction treatment: utility of diazepam administration. Clin Neuropharmacol 1999;22:60-2
77. Dyer JE, Roth B, Hyma BA. Gamma-hydroxybutyrate withdrawal syndrome. Ann Emerg Med 2001;37:147-53
78. Nightingale SL. From the Food and Drug Administration: warning about GHB. JAMA 1991;265:1802
79. Tunnicliff G, Raess BU. Gamma-Hydroxybutyrate (orphan medical). Curr Opin Investig Drugs 2002;3:278-83
80. Wang GY, Swick TJ, Carter LP, et al. Safety overview of postmarketing and clinical experience of sodium oxybate (XYREM-): abuse, misuse, dependence, and diversion. J Clin Sleep Med 2009;5:4-365-71
81. Beghe F, Carpanini MT. Safety and tolerability of gamma-hydroxybutyric acid in the treatment of alcoholdependent patients. Alcohol 2000;20:223-5
82. Gallimberti L, Spella MR, Soncini CA, Gessa GL. Gamma-hydroxybutyric acid in the treatment of alcohol and heroin dependence. Alcohol 2000;20:257-62
83. Addolorato G, Cibin M, Capristo E, et al. Maintaining abstinence from alcohol by gamma-hydroxybutyric acid. Lancet 1998;351:38
84. Caputo F, Francini S, Stoppo M, et al. Incidence of craving for and abuse of gamma-hydroxybutyric acid (GHB) in different populations of treated alcoholics: an open comparative study. J Psychopharmacol 2009;23:883-90
85. Caputo F, Francini S, Brambilla R, et al. Sodium oxybate in maintaining alcohol abstinence in alcoholic patients with and without psychiatric comorbidity. Eur Neuropsychopharmacol 2011;21:450-6
86. Chick J, Nutt DJ. Substitution therapy for alcoholism: time for a reappraisal? J Psychopharmacol 2012;26:205-12
87. Lesch OM, Henriette W, Wetschka C, et al. Alcohl and tobacco-medical and sociological aspects of use, abuse and addiction. Springerverlag Wien; New York; 2011. p. 134-69
88. Johnson BA, Ait-Daoud N, Seneviratne C, et al. Pharmacogenetic approach at the serotonin transporter gene as a method of reducing the severity of alcohol drinking. Am J Psychiatry 2011;168:265-75
89. Anton RF, Oroszi G, OMalley S, et al. An evaluation of mu-opioid receptor (OPRM1) as a predictor of naltrexone response in the treatment of alcohol dependence: results from the Combined Pharmacotherapies and Behavioural Interventions for Alcohol Dependence (COMBINE) study. Arch Gen Psychiatry 2008;65:135-44
90. Kiefer F, Witt SH, Frank J, et al. Involvement of the atrial natriuretic peptide transcription factor GATA4 in alcohol dependence, relapse risk and treatment response to acamprosate. Pharmacogenomics J 2011;11:368-74
91. Mutschler J, Abbruzzese E, Witt SH, et al. Functional polymorphism of the dopamine b-hydroxylase gene is associated with increased risk of disulfiram-induced adverse effects in alcohol-dependent patients. J Clin Psychopharmacol 2012;32:578-80