Naltrexone in alcohol dependence: a randomised controlled trial of effectiveness in a standard clinical setting

Abstract

Objectives: To determine whether naltrexone is beneficial in the treatment of alcohol dependence in the absence of obligatory pyschosocial intervention. Design: Multicentre, randomised, double‐blind, placebo‐controlled trial. Setting: Hospital‐based drug and alcohol clinics, 18 March 1998 – 22 October 1999. Patients: 107 patients (mean age, 45 years) fulfilling Diagnostic and statistical manual of mental disorders (4th edition) criteria for alcohol dependence. Interventions: Patients with alcohol dependence were randomly allocated to naltrexone (50 mg/day) or placebo for 12 weeks. They were medically assessed, reviewed and advised by one physician, and encouraged to strive for abstinence and attend counselling and/or Alcoholics Anonymous, but this was not obligatory. Main outcome measures: Relapse rate; time to first relapse; side effects. Results: On an intention‐to‐treat basis, the Kaplan–Meier survival curve showed a clear advantage in relapse rates for naltrexone over placebo (log‐rank test, χ21 = 4.15; P = 0.042). This treatment effect was most marked in the first 6 weeks of the trial. The median time to relapse was 90 days for naltrexone, compared with 42 days for placebo. In absolute numbers, 19 of 56 patients (33.9%) taking naltrexone relapsed, compared with 27 of 51 patients (52.9%) taking placebo (P = 0.047). Naltrexone was well tolerated. Conclusions: Unlike previous studies, we have shown that naltrexone with adjunctive medical advice is effective in the treatment of alcohol dependence irrespective of whether it is accompanied by psychosocial interventions.

Anti-relapse medications: Preclinical models for drug addiction treatment

“…However, the pharmacological criterion validity of the reinstatement model appears promising in the cases of alcohol, heroin, and nicotine (Epstein et al, 2006). As we will discuss later, clinical trials have been conducted specifically to test medications (e.g., naltrexone and acamprosate) for relapse prevention in abstinent alcoholics (Latt et al, 2002; Tempesta et al, 2000). Drugs that modulate opioid function, specifically naltrexone (Comer et al, 2006), methadone (Leri et al, 2004), and buprenorphine (Sorge et al, 2005) showed promising results for prevention of opioid relapse.…”

Varenicline, low dose naltrexone, and their combination for heavy-drinking smokers: human laboratory findings

“…Naltrexone pharmacotherapy, at a standard dose of 50 mg/day, has been found to reduce: relapse rates (Heinala et al 2001; Latt et al 2002; Volpicelli et al 1992), the number of drinking days (O’Malley et al 1992; Volpicelli et al 1992), the frequency of heavy drinking days (Balldin et al 2003; Monti et al 2001; Rubio et al 2002), and drinks per drinking episode (Chick et al 2000; Guardia et al 2002; Morris et al 2001; O’Malley et al 1992) while increasing time to first relapse (Anton et al 1999; Guardia et al 2002; Kiefer et al 2003). In the large, multi-site, COMBINE Study, naltrexone (at a dose of 100 mg/day) was superior to placebo in term of percent days abstinent, when delivered in combination with medical management (Anton et al 2006), thus representing a first-line of treatment for alcoholism.…”

Understanding naltrexone mechanism of action and pharmacogenetics in Asian Americans via behavioral economics: A preliminary study.

“…Clinical trials have shown naltrexone to be a moderately effective treatment for alcohol dependence. Studies have found that naltrexone reduces the number of heavy drinking days (Balldin et al, 2003; Monti et al, 2001; Rubio et al, 2002; Rubio, Ponce, & Manzanares, 2002), increases time to relapse (Anton et al, 1999; Guardia et al, 2002; Kiefer et al, 2003), yields lower relapse rates (Heinala et al, 2001; Latt, Jurd, Houseman, & Wutzke, 2002; Volpicelli, Alterman, Hayashida, & O’Brien, 1992), reduces the number of drinking days (O’Malley et al, 1992; Volpicelli, et al, 1992), and reduces the number of drinks per drinking episode (Chick et al, 2000; Guardia, et al, 2002; Morris, Hopwood, Whelan, Gardiner, & Drummond, 2001; O’Malley, et al, 1992). A large multi-site controlled trial found that naltrexone was an effective treatment for alcohol dependence when delivered in combination with a brief medically-oriented behavioral intervention (Anton et al, 2006).…”