Lack of Efficacy of Naltrexone in the Prevention of Alcohol Relapse: Results From a German Multicenter Study

Abstract

In a placebo-controlled, double-blind German multicenter study (seven sites) the efficacy of naltrexone as an adjunctive treatment in alcoholism to maintain abstinence was assessed for 12 weeks. A total of 171 detoxified patients (97.7% met the DSM-III-R criteria for alcohol dependence) were included. Patients had been abstinent for a mean of 19.5 +/- 9.4 days at study entry. Eighty-four and 87 patients were randomized to receive naltrexone (50 mg/day) and placebo, respectively. Each site was instructed to provide its usual psychosocial alcohol treatment program. The primary effectiveness measure was the time to first heavy drinking as derived from self-reports of drinking (timeline-follow-back method). Secondary effectiveness measures included time to first drink, amount of alcohol consumption, intensity of craving, severity of alcoholism problems, and liver enzymes. Thirty-three (38%) placebo patients and 28 (33%) naltrexone patients discontinued the study. At endpoint, 62% of the patients in each group did not have an episode of heavy drinking. Also, there were no significant differences between the study groups concerning secondary effectiveness measures as well as compliance and adverse clinical events--with the exception of the gamma-GT, which was significantly greater reduced in the naltrexone group throughout the study. Based upon an intention-to-treat population, this study confirms the safety but not the efficacy of naltrexone in prevention of alcohol relapse. Nevertheless, the question arises whether self-reports of drinking are more reliable than gamma-GT as a measure of recent alcohol consumption.

Prolonged Central μ-Opioid Receptor Occupancy after Single and Repeated Nalmefene Dosing

“…The current guidelines for the pharmacotherapy of alcohol dependence with opioid antagonist recommends daily use of naltrexone alongside nonpharmacological interventions (Balldin et al, 2003;O'Malley et al, 2003;O'Malley, 1995;Srisurapanont and Jarusuraisin, 2002). However, the treatment regimen has failed to reduce alcohol drinking in several studies (Gastpar et al, 2002;Krystal et al, 2001) and patients treated with naltrexone have experienced adverse effects that have led to poor medication compliance and impaired treatment outcome (Kranzler et al, 2000;Oncken et al, 2001).…”

Pharmacological Relapse Prevention of Alcoholism: Clinical Predictors of Outcome

“…Up to now, the results of eleven controlled studies with a total of about 1,500 patients have been published [18][19][20][21][22][23][24][25][26][27][28] . With the exception of three trials [24,27,28] , results revealed a superiority of naltrexone to placebo. Patients receiving naltrexone were less likely to relapse to heavy drinking and had fewer drinking days.…”

How Many Cravings? Pharmacological Aspects of Craving Treatment in Alcohol Addiction: A Review

“…In line with these last data, the subsequent multicenter study by Gastpar et al [21] also confi rmed the safety but not the effi cacy of naltrexone in alcohol relapse prevention.…”