Table 1.

Key studies leading to FDA approval of acamprosate

Study	Design	Study subjects	Main findings
Pelc et al 1997	90-day, double-blind, placebo-controlled trial. Participants randomly assigned to 1 of 3 groups: acamprosate 1998 mg/day, 1332 mg/day, or placebo. Study medication initiated during 14-day inpatient detoxification program.	188 alcohol-dependent males and females (18–65 years, weighing >60 kg). Subjects were included after a 14-day inpatient detoxification program, during which the study medication was started.	Acamprosate superior to placebo (p<0.001) in maintaining abstinence, prolonging time to first drink. Trend towards a better effect at higher dosage. Acamprosate appeared to be extremely safe.
Sass et al 1996	48-week, double-blind, placebo-controlled trial. Participants randomized to acamprosate were dosed by weight (weight >60 kg received 1998 mg/day; weight <60 kg received 1332 mg/day). Study medication initiated after 14- to 28-day inpatient detoxification period.	272 newly detoxified alcohol-dependent patients from 12 psychiatric outpatient clinics in Germany. Subjects had to be abstinent from alcohol for a minimum of 14 days and maximum of 28 days, and be free of withdrawal symptoms.	Those receiving acamprosate showed higher continuous abstinence rate (p=0.05) and longer mean abstinence duration (p<0.001). Few side-effects with acamprosate were recorded.
Paille et al 1995	52-week, double-blind, placebo-controlled trial. Participants randomly assigned to 1 of 3 groups: acamprosate 1998 mg/day, 1332 mg/day, or placebo. Study medication initiated after 7- to 28-day detoxification period.	538 alcohol-dependent males and females (18–65 years). Subjects had to have undergone detoxification, be abstinent at the time of enrollment, and be participating in specialized outpatient treatment for alcoholism. These subjects were predominantly male and tended to have a stable lifestyle in terms of family and occupation.	Those on high dose acamprosate were more likely to remain abstinent than those on low dose or placebo (and those on low dose acamprosate were more likely to remain abstinent than placebo). Statistical difference at 6 months (p<0.02) but not at 12 months (p=0.096)