Regular article Naltrexone improves outcome of a controlled drinking program Gabriel Rubio, M.D., Ph.D. a, *, Jorge Manzanares, Ph.D. a , Francisco Lopez-Mun ˜ oz, M.D., Ph.D. b , Cecilio Alamo, M.D., Ph.D. b , Guillermo Ponce, M.D. a , Miguel A. Jimenez-Arriero, M.D. a , Toma ´s Palomo, M.D., Ph.D. a a Unidad de Conductas Adictivas, Servicio de Psiquiatria, Pabellon de Medicina Comunitaria, Hospital Universitario 12 de Octubre, Avda de Co ´rdoba s/n,. 28041 Madrid, Spain b Departamento de Farmacologı ´a y Fisiologı ´a, Universidad de Alcala ´ de Henares, Madrid, Spain Received 29 September 2001; received in revised form 5 July 2002; accepted 7 August 2002 Abstract Naltrexone is widely used in therapeutic programs with abstinence as a goal. However, it has been used in only a few studies aimed at reducing alcohol consumption. The purpose of this study was to evaluate the efficacy of naltrexone as an adjunct in controlled drinking programs. This was an open randomized study of 12 weeks duration that compared two therapeutic strategies: use of naltrexone in a controlled drinking program (NTX + CD) and the controlled drinking program alone (CD), without NTX. Each group comprised 30 male patients with mild alcohol dependence. During treatment, there were no differences between groups in drinking behavior, though the NTX + CD group showed significantly less craving. In the 12-month follow-up period, the NTX + CD group showed significantly fewer drinking days and heavy drinking days and less craving than the CD group. The results of this study suggest a role for naltrexone in controlled drinking programs. D 2002 Elsevier Science Inc. All rights reserved. Keywords: Naltrexone; Controlled drinking; Alcoholism; Outcome; Follow-up 1. Introduction Controlled drinking programs are among the most con- troversial forms of treatment for alcohol dependence (Sobell et al., 1995). Some authors have defended their use in certain groups of subjects (Miller, Leckman, Delaney, & Tinkcom, 1992; Orford and Keddie, 1986; Sobell and Sobell, 1994), whereas others have questioned their validity and even the ethics of this type of therapy (Pendery, Maltzman, & West, 1982). In an extensive review on the efficacy of these kinds of programs it was suggested that they could be useful in young patients with mild to moderate dependence and a short dependence course (Miller and Caddy, 1977). This kind of patient is usually seen by the general practitioner and treated with brief interventions, although some are referred to a psychiatrist for longer-term therapies, such as controlled drinking programs (Rubio, Bardo ´n, & Lertxundi, 2000). In recent years, naltrexone has been introduced in the treatment of alcohol dependence, and has proved more effective than placebo in both short and long term studies (Chick et al., 2000; O’Malley et al., 1996; Rubio, Jime ´nez-Arriero, Ponce, & Palomo, 2001; Volpicelli et al., 1997). It has also been found to improve outcome of cognitive behavioral therapy (Anton et al., 1999). Naltrexone reduces the craving before drinking and also that elicited by alcohol consumption. It also reduces the number of drinking days and the number of drinks taken each time (O’Malley et al., 1996; Volpicelli et al., 1997). Considering the ability of naltrexone to reduce craving elicited by alcohol and the large number of patients with mild dependence seen in primary care, it is surprising how few studies have used this drug as a coadjuvant in programs aimed at reducing alcohol consumption in this population. To our knowledge, only two noncontrolled open studies have been published in which the efficacy of naltrexone has been demonstrated in reducing consumption in early problem drinkers (Bohn, Kranzler, Beazoglou, & Staehler, 1994; Kranzler, Tennen, Penta, & Bohn, 1997). The purpose of this study was to determine the ability of naltrexone to improve the results of a controlled drinking program and to establish the duration of the effect after discontinuing the medication. 0740-5472/02/$ – see front matter D 2002 Elsevier Science Inc. All rights reserved. PII:S0740-5472(02)00296-9 * Corresponding author. Tel.: +34-1-390-8022; fax: +34-1-390-8598. E-mail address: garuva@inicia.es (G. Rubio). Journal of Substance Abuse Treatment 23 (2002) 361 – 366