Romach Myroslava K, Sellers Edward M, Somer Gail R, Landry Michel, Cunningham Graeme M, Jovey Roman D, McKay Charles, Boislard Jean, Mercier Céline, Pépin Jean-Marc, Perreault Jean, Lemire Eliane, Baker Raymond P, Campbell William, Ryan Daniel
Department of Psychiatry, University of Toronto.
Can J Clin Pharmacol. 2002 Fall;9(3):130-6.
Alcohol dependence is a prevalent psychiatric disorder affecting approximately 12% of the adult population at some point in their lifetime. Psychosocial treatments are associated with only modest success rates. The first Canadian clinical trial with naltrexone, an opiate antagonist, was conducted to evaluate its safety and usefulness as an adjunctive treatment in the management of alcohol dependence.
One hundred twenty alcohol-dependent individuals were assessed to receive treatment with 50 mg of naltrexone orally for 12 weeks in an open-label trial. Patients were seen biweekly and received a concurrent psychosocial intervention. Treatment was conducted at multiple sites in Canada.
Fifty-four per cent of subjects completed the entire 12 weeks of treatment. During the study, 39% of patients abstained, while of the individuals reporting drinking at baseline, 86% were consuming less alcohol by their final visit. These reductions were accompanied by a significant decrease in craving for alcohol at week 12, as measured by the Obsessive Compulsive Drinking Scale (P<0.01). Naltrexone was well tolerated and no serious adverse events were experienced.
The data lend support to the hypothesis that endogenous opioid activity is involved in the regulation of alcohol intake, and that antagonists of endogenous opioids decrease craving and drinking. Opiate antagonists such as naltrexone are a new strategy in the treatment of alcohol dependence. Naltrexone can be safely given to female and male alcoholics, is acceptable to patients, and plays a role in reducing alcohol consumption and preventing relapse to heavy drinking.
酒精依赖是一种常见的精神疾病，在一生中的某个阶段影响着约12%的成年人口。心理社会治疗的成功率仅为中等。在加拿大进行了第一项关于纳曲酮（一种阿片类拮抗剂）的临床试验，以评估其作为酒精依赖管理辅助治疗的安全性和有效性。
在一项开放标签试验中，对120名酒精依赖个体进行评估，给予口服50毫克纳曲酮治疗12周。患者每两周就诊一次，并接受同步的心理社会干预。治疗在加拿大的多个地点进行。
54%的受试者完成了整个12周的治疗。在研究期间，39%的患者戒酒，而在基线报告饮酒的个体中，86%在最后一次就诊时饮酒量减少。这些减少伴随着通过强迫性饮酒量表测量的第12周对酒精渴望的显著降低（P<0.01）。纳曲酮耐受性良好，未出现严重不良事件。
数据支持内源性阿片类活性参与酒精摄入调节的假说，并且内源性阿片类拮抗剂可减少渴望和饮酒。诸如纳曲酮之类的阿片类拮抗剂是治疗酒精依赖的一种新策略。纳曲酮可安全地给予男性和女性酗酒者，患者可接受，并且在减少酒精消费和预防重度饮酒复发方面发挥作用。
