TY  - JOUR
T1  - A double-blind, placebo-controlled study of oral nalmefene for alcohol dependence
AU  - Mason BJ, Salvato FR, Williams LD, Ritvo EC, Cutler RB
Y1  - 1999/08/01
N1  - 10.1001/archpsyc.56.8.719
JO  - Archives of General Psychiatry
SP  - 719
EP  - 724
VL  - 56
IS  - 8
N2  - Background 
    Nalmefene is a newer opioid antagonist that is structurally similar to naltrexone but with a number of potential pharmacological advantages for the treatment of alcohol dependence, including no dose-dependent association with toxic effects to the liver, greater oral bioavailability, longer duration of antagonist action, and more competitive binding with opioid receptor subtypes that are thought to reinforce drinking.Methods 
    A double-blind, placebo-controlled trial was conducted to evaluate the safety and efficacy of 2 doses of oral nalmefene for alcohol dependence. The 105 outpatient volunteers were abstinent for a mean of 2 weeks prior to random assignment to the placebo or 20- or 80-mg/d dose nalmefene groups for 12 weeks. Cognitive behavioral therapy was provided weekly during treatment. Self-reported drinking or abstinence was confirmed by determinations of breath alcohol concentration and by collateral informant reports.Results 
    Outcomes did not differ between the 20- and 80-mg dose nalmefene groups. Significantly fewer patients treated with nalmefene than patients given placebo relapsed to heavy drinking through 12 weeks of treatment (P<.02), with a significant treatment effect at the first weekly study visit (P<.02). The odds ratio of relapsing to heavy drinking was 2.4 times greater with placebo compared with nalmefene (95% confidence interval, 1.05-5.59). Patients treated with nalmefene also had fewer subsequent relapses (P<.03) than patients given placebo.Conclusions 
    Treatment with nalmefene was effective in preventing relapse to heavy drinking relative to placebo in alcohol-dependent outpatients and was accompanied by acceptable side effects.
SN  - 0003-990X
M3  - doi: 10.1001/archpsyc.56.8.719
UR  - http://dx.doi.org/10.1001/archpsyc.56.8.719
ER  -