Choosing pharmacotherapies for the COMBINE Study--process and procedures: an investigational approach to combination pharmacotherapy for the treatment of alcohol dependence.

Robert Swift, Helen M Pettinati
{"title":"Choosing pharmacotherapies for the COMBINE Study--process and procedures: an investigational approach to combination pharmacotherapy for the treatment of alcohol dependence.","authors":"Robert Swift,&nbsp;Helen M Pettinati","doi":"10.15288/jsas.2005.s15.141","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>This article describes the process by whichthe COMBINE investigators evaluated and chose the two pharmacotherapies to be studied in COMBINE.</p><p><strong>Method: </strong>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.</p><p><strong>Results: </strong>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</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":17056,"journal":{"name":"Journal of studies on alcohol. Supplement","volume":" 15","pages":"141-7; discussion 140"},"PeriodicalIF":0.0000,"publicationDate":"2005-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"12","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of studies on alcohol. Supplement","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.15288/jsas.2005.s15.141","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 12

Abstract

Objective: This article describes the process by whichthe COMBINE investigators evaluated and chose the two pharmacotherapies to be studied in COMBINE.

Method: 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.

Results: 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

Conclusions: 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.

为联合研究选择药物疗法——过程和程序:联合药物疗法治疗酒精依赖的研究方法。
目的:介绍联合用药研究人员评价和选择联合用药研究的两种药物治疗方法的过程。方法:药物治疗是通过一个共识过程来选择的,包括评估已知的神经药理学药物,以改变动物和人类的酒精消耗或其他与酒精相关的行为。根据已发表的证据对药物进行分类,在人体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、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结合等方面的证据。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,即联合应急事件处理系统评估。结果:纳曲酮的剂量为100毫克/天,阿坎普罗酸的剂量为3000毫克/天,被选择用于研究。药物治疗为期4个月,同时进行联合心理治疗。结论:药物治疗和安全监测方面的决策结果导致了一项计划良好、执行良好的研究,将参与者的风险降到最低。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
来源期刊
自引率
0.00%
发文量
0
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术官方微信