Calcium carbimide in alcoholism treatment. Part 2: Medical findings of a short-term, placebo-controlled, double-blind clinical trial.

Drug-induced toxicity in chronic alcoholics who participated in a 4-month placebo (Pl)--controlled clinical trial of the efficacy of calcium carbimide (CC) is reported. Daily monitoring of patients' compliance indicated that 85% of study medications were taken, and very little drinking took place during the study. Patients did not report more symptoms or experience more medical problems during CC administration than during placebo administration. There was no evidence of hepatotoxicity, or behavioural toxicity. Mean white blood cell count was slightly increased during CC treatment, and returned to baseline values when CC was stopped. Thyroid function was not affected by CC in patients with normal pretreatment function. However one patient with pretreatment reduced thyroid function became hypothyroid after CC administration, which indicates a need for systematic monitoring. We conclude that CC is safe for use in alcoholics with normal thyroid function, and may be the preferred alcohol-sensitizing drug in some situations.

Calcium carbimide in alcoholism treatment. Part 1: A placebo-controlled, double-blind clinical trial of short-term efficacy.

A randomized, double-blind, placebo-controlled single cross-over study of the alcohol sensitizing drug, calcium carbimide (CC), was conducted in 128 patients with alcohol dependence. Seventy-one (55%) completed the 4-month study. Patients reported drinking and pill-taking behaviour, and submitted urines (for analysis of alcohol and the tablet marker riboflavin) on 97%, and 91% of treatment days, respectively. All of the 69 analyzable completers were abstinent on at least 85% of days, and 58% (40) were alcohol-free during the study. Medications were taken on at least 85% of days. Symptoms and adverse clinical findings were not increased in frequency during CC, compared to placebo. Seventy-eight per cent of the patients believed they had received CC throughout the study, suggesting that CC exerts a strong psychological deterrent effect. Alcohol consumption was significantly reduced to the same extent with CC and placebo, compared to pre-treatment levels.