Table 1.
Review of open-label and single-blind acamprosate trials
| Authors | Treatment groups | Length | Sample | n | Outcomes | Side effects |
|---|---|---|---|---|---|---|
| Croissant et al45 | Acamprosate 1998 mg/day versus oxcarbazepine 150 mg/day to 1200 mg/day over 12 days | 24 weeks | Acutely detoxified alcohol-dependent patients | 30 | NS, oxcarbazepine had more days until first drinking day (96 days) compared with acamprosate (66 days). Days until severe relapse, oxcarbazepine (97 days) versus acamprosate (77 days) | Tiredness (n = 2), vegetative symptoms (n = 2) |
| de Sousa42 | Acamprosate 1998 mg/day, disulfiram 250 mg/day | 8 months | Detoxified alcohol-dependent patients | 100 | Days until lapse: disulfiram (123 days)* versus acamprosate (71 days). Continuous abstinence: disulfiram (88%)*, acamprosate (46%) | Insomnia (n = 28), nausea (3%–4% of subjects) |
| Kampman et al (2009) | Acamprosate 1998 mg/day versus placebo | 10 weeks | Alcohol-dependent patients start of detoxification | 40 | NS, placebo group had fewer percent drinking days (19%) compared with acamprosate (34%) | Aches and pains (n = 11), diarrhea (n = 7), headache (n = 7), skin rash (n = 7) |
| Kiritze-Topor et al43 | Acamprosate 1332 mg/day (weight < 60 kg), 1998 mg/day (weight > 60 kg) versus standard care | 12 months | Adult patients with alcohol dependence at beginning of detoxification | 422 | Cumulative abstinence days: acamprosate (81%)* versus standard care alone (67%) | Death (n = 10, not attributable to treatment), adverse events (n = 2, no specific side effects were mentioned) |
| Laaksonen et al41 | Acamprosate 1998 mg/day, disulfiram 200 mg/day, naltrexone 50 mg/day | 119 weeks | Voluntary treatment-seeking alcohol-dependent adult outpatients | 243 | Days to first heavy drinking day: acamprosate 17.6, disulfiram 46.6*, naltrexone 22.0. Abstinence days/week: acamprosate 4.5, disulfiram 6.3, naltrexone 4.6* | GI, nausea, vomiting (n = 14), skin symptoms (n = 7), dizziness (n = 4), sexual dysfunction (n = 1), other (n = 4) |
| Paille et al44 | Acamprosate 1332 mg/day or 1998 mg/day versus placebo | 12 months | Alcohol-dependent patients after detoxification | 538 | Continuous abstinence days greatest for high-dose group (153 days)*, followed by low-dose group (135 days)* then the placebo group (102 days) | Diarrhea |
| Pelc et al (2002) | Acamprosate 1332 mg/day (weight < 60 kg), 1998 mg/day (weight > 60 kg) + standard care | 24 weeks | Alcohol-dependent patients | 1289 | Median time to relapse (average 12 weeks). Total abstinence: average of 24.4% | GI (n = 278), headache (n = 88), nausea (n = 55), psychological disorders (n = 94), sleep disorders or tiredness (n = 107), pruritus (n = 49) |
| Rubio et al40 | Acamprosate 1665–1998 mg/day (based on weight) versus naltrexone 50 mg/day | 12 months | Recently detoxified alcohol-dependent men with moderate dependence | 157 | Time to heavy drinking day: naltrexone 63 days* versus acamprosate 42 days. Number of abstinent days at one-year: naltrexone 243 days* versus acamprosate 180 days | Headache (6%), nausea (4%), diarrhea (4%), epigastric discomfort (4%), drowsiness (2%), nasal congestion (1%) |
| Soyka et al46 | Acamprosate 1332 mg/day (weight < 60 kg), 1998 mg/day (weight > 60 kg) + psychotherapy | 24 weeks | Recently detoxified alcohol-dependent patients | 753 | Time until first drink was 81.5 days; 33.5% continuous abstinence; 101.6 cumulative abstinent days at 24 weeks | Diarrhea or loose stools (n = 90), itching (n = 36), headache (n = 28), fatigue (n = 16), sleep (n = 11), nausea (n = 10), viral infection (n = 10) |
*
Note: P < 0.05 versus comparison groups.
Abbreviations: NS, nonsignificant findings; GI, gastrointestinal.