Swift Robert, Pettinati Helen M
Center for Alcohol and Addiction Studies, Department of Psychiatry and Human Behavior, Brown University, Box G-BH, Providence, Rhode Island 02912, USA.
J Stud Alcohol Suppl. 2005 Jul(15):141-7; discussion 140. doi: 10.15288/jsas.2005.s15.141.
This article describes the process by whichthe COMBINE investigators evaluated and chose the two pharmacotherapies to be studied in COMBINE.
The pharmacotherapies were chosen through a consensus process that involved the evaluation of neuropharmacological agents known to modify alcohol consumption or other alcohol-related behaviors in animals and humans. Medications were classified according to the published evidence, with the highest ranking given to those with evidence of efficacy in human clinical trials. The investigators also considered evidence for safety, potential drug-drug interactions, management of side effects, optimal dose, treatment duration, availability of the medication and integration with the psychosocial therapies. The full evaluation required conducting two pilot studies and the development of an instrument to monitor safety, the COMBINE Systematic Assessment for Treatment Emergent Events.
Naltrexone, at a dose of 100 mg per day, and acamprosate, at a dose of 3,000 mg per day, were chosen for the study. The medications were administered for a period of 4 months, concurrent with the COMBINE psychosocial therapies
The results of the decision making with respect to medications and safety monitoring resulted in a well-planned and well-executed study that minimized risks to the participants.
本文描述了联合研究组评估并选择两种药物疗法用于联合研究（COMBINE）的过程。
通过一个共识过程选择药物疗法，该过程涉及对已知可改变动物和人类饮酒量或其他与酒精相关行为的神经药理学药物进行评估。药物根据已发表的证据进行分类，在人类临床试验中有疗效证据的药物排名最高。研究人员还考虑了安全性证据、潜在的药物相互作用、副作用管理、最佳剂量、治疗持续时间、药物的可获得性以及与心理社会疗法的整合。全面评估需要进行两项试点研究，并开发一种监测安全性的工具，即联合治疗突发事件系统评估（COMBINE Systematic Assessment for Treatment Emergent Events）。
选择了每日剂量为100毫克的纳曲酮和每日剂量为3000毫克的阿坎酸用于该研究。这些药物与联合心理社会疗法同时给药4个月。
关于药物和安全监测的决策结果促成了一项精心策划和执行的研究，将参与者的风险降至最低。
