Naltrexone and acamprosate reduce relapse in alcohol dependence. They have
not yet been compared in a published trial. The aim of this study was to co
mpare the efficacy of these compounds in conditions similar to those in rou
tine clinical practice. Random allocation to a year of treatment with naltr
exone (50 mg/day) or acamprosate (1665-1998 mg/day) was made in 157 recentl
y detoxified alcohol-dependent men with moderate dependence (evaluated usin
g the Addictions Severity Index and Severity of Alcohol Dependence Scale).
All were patients whom a member of the family would accompany regularly to
appointments. Alcohol consumption, craving and adverse events were recorded
weekly for the first 3 months, and then bi-weekly, by the treating psychia
trist who was not blinded. At 3-monthly intervals, investigators who were b
linded to the treatment documented patients' alcohol consumption based on p
atients' accounts, information given by the psychiatrists when necessary, a
nd reports from patients' families. Serum gamma-glutamyltransferase (GGT) w
as also measured. Efforts were made to sustain the blindness of the investi
gators. The same investigator did not assess the same patient twice. The in
tegrity of the blindness was not checked. There was no difference between t
reatments in mean time to first drink (naltrexone 44 days, acamprosate 39 d
ays) but the time to first relapse (five or more drinks in a day) was 63 da
ys (naltrexone) versus 42 days (acamprosate) (P = 0.02). At the end of 1 ye
ar, 41% receiving naltrexone and 17% receiving acamprosate had not relapsed
(P = 0.0009). The cumulative number of days of abstinence was significantl
y greater, and the number of drinks consumed at one time and severity of cr
aving were significantly less, in the naltrexone group compared to the acam
prosate group, as was the percentage of heavy drinking days (P = 0.038). Mo
re patients in the acamprosate than the naltrexone group were commenced on
disulfiram during the study. Naltrexone patients attended significantly mor
e group therapy sessions, though this could not explain their better outcom
e. There were non-significant trends for the naltrexone group to comply bet
ter with medication, to stay in the study longer, and to show greater impro
vement over baseline in serum GGT.