Comparing and combining gamma-hydroxybutyric acid (GHB) and naltrexone in maintaining abstinence from alcohol: An open randomised comparative study Fabio Caputo a,b, ⁎ ,1 , Giovanni Addolorato c , Michela Stoppo a , Sara Francini a , Teo Vignoli a , Francesca Lorenzini a , Arfedele Del Re b , Claudio Comaschi b , Pietro Andreone a , Franco Trevisani a , Mauro Bernardi a a “G. Fontana” Centre for the Study and Multidisciplinary Treatment of Alcohol Addiction, Department of Internal Medicine, Cardioangiology and Hepatology, University of Bologna, Italy b Unit for Addiction Treatment, Department of Mental Health, ASL of Bologna, Italy c Institute of Internal Medicine, Catholic University of Sacred Hearth, Roma, Italy Received 23 December 2006; received in revised form 17 April 2007; accepted 25 April 2007 Abstract Maintaining abstinence from alcohol is the main goal in treating alcohol dependence. Our aim was to evaluate the efficacy of gamma-hydroxybutyric acid (GHB) and naltrexone (NTX), and their combination in maintaining abstinence. Fifty-five alcoholics were randomly enrolled in three groups and treated for 3 months with GHB, GHB plus NTX, and NTX, respectively. At the end of treatments, abstinence was maintained by 13 patients (72.2%) in combination group, 8 patients (40%; P =0.03) in GHB group, and one patient (5.9%; P =0.0001) in NTX group. Relapses in heavy drinking tended to occur more frequently in GHB group (15%) than in either combination group (no cases) or NTX group (5.9%), but such differences were not statistically significant. The GHB/NTX combination was more effective than either drug given alone; this suggests that the two drugs combine their different actions synergistically without suppressing the favourable effects of each other. © 2007 Elsevier B.V. and ECPN. All rights reserved. KEYWORDS Gamma-hydroxybutyric acid; Naltrexone; Combined pharmacological treatment; Maintaining abstinence from alcohol 1. Introduction Sustained abstinence from alcohol is the main goal in the treatment of alcohol dependence. Although several phar- macological agents are effective in maintaining abstinence from alcohol and preventing relapses (Heilig and Egli, 2006; Johnson et al., 2005), the rate of treatment failures within a year of detoxification program remains still high (Mann, 2004). Combination therapies have been employed and proved to be effective in achieving alcohol abstinence ⁎ Corresponding author. “G. Fontana” Centre for the Study and Multidisciplinary Treatment of Alcohol Addiction, Department of Internal Medicine, Cardioangiology and Hepatology, University of Bologna, Via Massarenti 9, 40138 Bologna, Italy. Tel.: +39 051 6364109; fax: +39 051 6362930. E-mail address: fabio-caputo@libero.it (F. Caputo). 1 Present address: Department of Internal Medicine, SS Annunziata Hospital, Via Vicini 2, 44042 Cento (Ferrara), Italy. Tel.: +39 051 6838309; fax: +39 051 6838304. 0924-977X/$ - see front matter © 2007 Elsevier B.V. and ECPN. All rights reserved. doi:10.1016/j.euroneuro.2007.04.008 www.elsevier.com/locate/euroneuro European Neuropsychopharmacology (2007) xx, xxx–xxx ARTICLE IN PRESS NEUPSY-09988; No of Pages 9 Please cite this article as: Caputo, F. et al. Comparing and combining gamma-hydroxybutyric acid (GHB) and naltrexone in maintaining abstinence from alcohol: An open randomised .... Eur. Neuropsychopharmacol. (2007), doi:10.1016/j.euroneuro.2007.04.008