Efficacy and safety of acamprosate in the treatment of detoxified alcohol-dependent patients. A 90-day placebo-controlled dose-finding study. Acamprosate treatment in a long-term community-based alcohol rehabilitation programme. Double-blind randomized multicentre trial of acamprosate in maintaining abstinence from alcohol. Relapse prevention by acamprosate. Results from a placebo-controlled study on alcohol dependence. Acamprosate and relapse prevention in the treatment of alcohol dependence: a placebo-controlled study. Acamprosate in alcohol dependence: a randomized controlled efficacy study in a standard clinical setting. Acamprosate and its efficacy in treating alcohol dependent adolescents. Acamprosate during and after acute alcohol withdrawal: a double-blind placebo-controlled study in Spain. [Acamprosate--a stabilizing factor in long-term withdrawal of alcoholic patients].
Acamprosate is a newly registered drug that appears to reduce alcohol-drinking in both animal models and clinical conditions.
                In order to assess the efficacy and safety of the drug in the treatment of detoxified alcoholics, we performed a 90-day double-blind trial comparing two dosages of acamprosate (1332 mg/day and 1998 mg/day).
                For all efficacy parameters, acamprosate appeared to be significantly superior to placebo, with a trend towards a better effect at the higher dosage. Furthermore, acamprosate appeared to be extremely safe.
                This study confirms that acamprosate could be an interesting adjuvant for maintaining abstinence in detoxified alcoholics. To evaluate the efficacy of acamprosate in maintaining abstinence in weaned alcohol-dependent patients.
                A multicentre, double-blind, randomized control trial. Patients were individually randomly allocated to active or placebo conditions. Abstinence was assessed during a 6-month treatment period and after a 6-month follow-up period.
                A community-based, outpatient alcohol rehabilitation programme.
                Two hundred and forty-six alcohol-dependent patients between the ages of 18 and 65 years were recruited immediately following acute, inpatient withdrawal treatment.
                The primary outcome measure was self-reported abstinence from alcohol since the previous sessions at 3, 6, 9 and 12 months following the start of treatment, with treatment taking place for a period of 6 months.
                A significantly higher proportion of patients in the acamprosate group were abstinent after 3 months and 6 months of treatment. The percentage of patients with continuous abstinence at the end of the treatment period was almost double for the acamprosate group than for the placebo group (40.7% vs. 20.8%, respectively). Acamprosate significantly increased the retention of patients in the treatment programme. Six months after drug treatment ceased, the criterion of abstinence since the previous visit was reached by significantly more patients from the acamprosate group (43.4%) than from the placebo group (29.8%), but this difference was not statistically significant at the 3-month point after cessation of study medication.
                Acamprosate may be a useful pharmacological compound for the long-term treatment of alcohol-dependence when applied in a community-based rehabilitation programme. A prospective placebo-controlled, randomized double-blind study of Acamprosate at two dose levels in alcohol-dependent patients followed up for 12 months was performed. After detoxification, each of the 538 patients included was randomly assigned to one of three groups: 177 patients received placebo, 188 received Acamprosate at 1.3 g/day (low dose group) and 173 received 2.0 g/day (high dose group) for 12 months. This was followed by a single blind 6 month period on placebo. The patients' mean age was 43.2 +/- 8.6 years. Their mean daily alcohol intake was high (nearly 200 g/day) and of long duration (9.5 +/- 7.1 years). Abstinence figures followed the order high dose > low dose > placebo. The difference was significant at 6 months (P < or = 0.02) but not at 12 months (P = 0.096). The number of days of continuous abstinence after detoxification was 153 +/- 197 for the high-dose group versus 102 +/- 165 for the placebo group (P = 0.005), with the lose-dose group reporting 135 +/- 189 days. Clinic attendance was significantly better in the Acamprosate groups than in the placebo group at 6 months (P = 0.002) and 12 months (P = 0.005). During the 6-month post-treatment period, no increased relapse rate or residual drug effect was observed. The side effect profile for Acamprosate was good compared with controls with only diarrhoea being reported more frequently (P < 0.01). This study confirms the pharmacological efficacy of Acamprosate and its good acceptability. As an adjunct to psychotherapy, this study supports the inclusion of Acamprosate in a strategy for treating alcoholism. The effectiveness of acamprosate (calcium bisacetylhomotaurinate) as a treatment to maintain abstinence in alcohol-dependent patients was assessed for 1 year.
                After short-term detoxification, 272 patients participated in a randomized, double-blind, placebo-controlled study. Patients received routine counseling and either the study medication or placebo for 48 weeks; they were followed up for another 48 weeks without medication. Statistical analysis was performed according to the intention-to-treat principle.
                Patients who were receiving acamprosate showed a significantly higher continuous abstinence rate within the first 60 days of treatment compared with patients who were assigned to placebo treatment (67% vs 50%) until completion of the treatment period (43% vs 21%, log rank P = .005), and they had a significantly longer mean abstinence duration of 224 vs 163 days, or 62% vs 45% days abstinent (P < .001); however, there was no difference in psychiatric symptoms. Of the patients who were receiving acamprosate, 41% had dropped out, whereas 60% of the placebo-treated patients dropped out of the study. Few side effects (mainly diarrhea and headache) were recorded. At the end of a further 48 weeks without receiving study medication, 39% and 17% of the acamprosate- and placebo-treated patients, respectively, had remained abstinent (P = .003).
                Acamprosate proved to be a safe and effective aid in treating alcohol-dependent patients and in maintaining the abstinence of patients during 2 years. The objective of this study was to compare acamprosate with placebo in the treatment of alcohol-dependent patients during a 6-month post-detoxification treatment and a 3-month medication-free follow-up. Patients (n = 330) were detoxified and randomized to treatment with acamprosate (1998 mg/day) or placebo within an out-patient programme including medical counselling, psychotherapy and self-help groups. The main outcome criterion was drinking behaviour as assessed by: abstinence/relapse ratio, cumulative abstinence duration (CAD) and the period of continued abstinence. Anxiety, depression and craving were also monitored. Intention to treat (ITT) statistical principles were followed. Twenty-five per cent of patients dropped out over the first 6 months. At the end of the treatment period, the abstinence rate was 57.9% for acamprosate and 45.2% for placebo (P = 0.03). The CAD was 110+/-77 days for acamprosate and 89+/-77 days for placebo (P = 0.016). Patients on acamprosate had a higher continuous abstinence rate and experienced less severe relapses. No differential effect was noted for anxiety, depression or craving. Treatment remained positive, but not significant, 3 months after termination of study medication. No significant difference in adverse events was noted between treatment groups. Acamprosate treatment over 180 days was consistently more effective than placebo to maintain abstinence and to diminish relapse severity. This study was undertaken to evaluate the efficacy and safety of acamprosate in the treatment of alcohol dependence.
                The investigation was a double-blind, placebo-controlled, 24-week study carried out at the University of São Paulo, Brazil. The sample comprised 75 patients, 18-60 years of age, with an International Classification of Diseases (ICD-10) diagnosis of alcohol dependence. After a 1-week detoxification period the patients were randomly divided into two groups: the first received acamprosate (1.998 mg/day) and the second received placebo. After the first 12 weeks, the patients continued follow-up for a similar length of time without medication. The main outcome measures were relapse rates, side effects and time to first relapse.
                On an intention-to-treat basis, the Kaplan-Meier survival curve showed an advantage in relapse rates for acamprosate over placebo (log-rank test, p = .02), and acamprosate was well tolerated.
                Acamprosate seems to be an effective treatment for alcohol dependence in a Brazilian population. About 50 % of adult alcoholic patients relapse within 3 months of treatment. Previous studies have suggested that acamprosate may help to prevent such relapse. The aim of our study was to assess the efficacy and safety of long-term acamprosate treatment in alcohol dependence of adolescents.
                In this, double-blind, placebo-controlled study, we recruited 26 patients, aged 16-19 years, with chronic or episodic alcohol dependence. Patients were randomly allocated treatment with acamprosate (1332 mg daily) or placebo for 90 days. Patients were assessed on the day treatment started and on days 30, and 90 by interview, self report, questionnaire, and laboratory screening.
                13 acamprosate-treated and 13 placebo-treated patients completed the treatment phase: of those withdrawn, 11 (1 vs 6) relapsed, 5 (3 vs 2) refused to continue treatment, 3 (1 vs 2) had concurrent illness, and 2 (1 vs 1) had adverse side-effects. At the end of treatment, 7 acamprosate treated and 2 placebo-treated patients had been continuously abstinent (p = 0.0076). Mean cumulative abstinence duration was significantly greater in the acamprosate group than in the placebo group (79.8 [SD 37.5] vs 32.8 [19.0] days; p = 0.012).
                Acamprosate is an effective and well-tolerated pharmacological adjunct to psychosocial treatment programmes. To test acamprosate's role as an aid in preventing relapse after detoxification, 296 alcohol-dependent patients entered a prospective, multicentre, randomized, double-blind, parallel comparison of acamprosate treatment consisting of two 333 mg tablets given three times daily for 180 days with matching placebo treatment. Unlike previous studies, acamprosate was prescribed from the start of alcohol withdrawal, rather than after the detoxification process. During the treatment period, 110 patients dropped out. The two treatment groups were balanced with regard to baseline values and reasons for discontinuation. There was no difference between the groups in the severity of withdrawal symptoms as measured by the CIWA-Ar (Clinical Institute Withdrawal Assessment for Alcohol scale). Acamprosate given during withdrawal did not cause unwanted effects. The cumulative abstinence duration (CAD, main end-point) was 19 days longer in the acamprosate treatment group than the placebo treatment group (analysis of variance on ranks, P = 0.0006) and the stable recovery duration, defined as the number of abstinent days between the last relapse into any drinking and the end of the trial, was 16 days longer in the acamprosate treatment group (P = 0.021). Continuous abstinence, estimated by survival analysis on time to first relapse, was achieved by 35% of acamprosate-treated patients and 26% of placebo-treated patients (log rank P = 0.068). The geometric mean of the ratio final/baseline values for serum carbohydrate-deficient transferrin was 0.802 (placebo) and 0.733 (acamprosate) (P = 0.059). The geometric mean of the ratio final/baseline values for serum gamma-glutamyltransferase was 0.496 (placebo) and 0.415 (acamprosate) (P = 0.024) which corroborated the greater abstinence reported by the acamprosate group. In a one-year double-blind-treatment study with acamprosat (six months with and six months without substance) the efficiency of this new medicament could be proved. The number of relapses in the treatment group was significantly lower during the first 30 days with a trend to further 150 days. The substance caused very few side effects.
Acamprosate appears to be an effective and safe treatment strategy for supporting continuous abstinence after detoxification in alcohol dependent patients. Even though the sizes of treatment effects appear to be rather moderate in their magnitude, they should be valued against the background of the relapsing nature of alcoholism and the limited therapeutic options currently available for its treatment.