Joint Behavior/Pharmacologic Treatment of Alcoholism

描述(由申请人提供)：本申请寻求两年的资金，以完成联合治疗及其辅助成本效益和遗传预测治疗反应的研究。 联合研究始于1997年，目的是回答有关联合益处的问题。 行为和药物干预。在美国和欧洲的一些临床试验中，纳曲酮和氨基己酸酯这两种药物在减少酗酒复发和改善戒酒方面显示出了希望。这两种行为疗法，医疗管理(MM)和联合行为干预(CBI)，有可能成为药物治疗的有价值的辅助手段。MM似乎具有成本效益，适合由非专科医生在初级保健或管理性保健环境中分娩。基本假设是，对于酒精依赖患者，将这两种药物(纳曲酮和氨基己酸酯)与中等强度的行为治疗(CBI)相结合将比强度较小的方法(如安慰剂和MM；阿卡米松或纳曲酮和MM)产生更好的结果。来自11个临床站点的1375名受试者组成了目标样本。符合研究标准的患者被随机分配到9种药理(纳曲酮和氨基己酸酯)和行为治疗(MM和CBI)组合中的一种，以形成完整的2x2x2析因设计。后来又加入了第九个细胞，用来测试没有“药片”的CBI的疗效。 自联合公司成立以来，已经取得了许多成就。超过70%的预期样本已被随机分配到研究治疗中，反映了性别、种族、地理和临床多样性。在为期16周的随访中，84%的客户完成了饮酒评估访谈。成功地完成了两项主要的试点研究，并在各次会议和出版物上散发了研究结果。所要求的两年延期将允许对其余参与者进行征聘、治疗和后续行动，并为数据分析和手稿准备留出足够的时间。联合研究的结果预计将对酒精治疗输送系统产生重大影响。 提交了一份跨每个研究地点的通用方案。这反映了指导该研究头五年工作的合作进程。然而，每个研究地点都提供了关于预算、预算理由、关键人员名单、顾问/联合体协议以及各自提案中的人类科目部分的具体地点信息。

DESCRIPTION (provided by applicant): The present application seeks two years of funding to complete COMBINE and its ancillary cost-effectiveness and genetic predictors of treatment response studies. The COMBINE study was initiated in 1997 to answer questions about the benefits of combining behavioral and pharmacological interventions. Two medications, naltrexone and acamprosate, have shown promise in reducing relapse to heavy drinking and improving abstinence in a number of U.S. and European clinical trials. The two behavioral treatments, Medical Management (MM) and Combined BehavioraI Intervention (CBI), have potential to be valuable adjuncts to pharmacotherapy. MM appears to be cost-effective and suitable for delivery in primary care or managed care settings by non-specialists. The primary hypothesis is that combining the two medications (naltrexone and acamprosate) with a moderate intensity behavioral treatment (CBI) will yield better outcomes than less intensive approaches (e.g., placebo and MM; acamprosate or naltrexone and MM) for alcohol dependent patients. A total of 1375 subjects from 11 clinical sites comprise the targeted sample. Individuals meeting study criteria have been randomly assigned to one of nine pharmacological (naltrexone and acamprosate) and behavioral treatment (MM and CBI) combinations to form a complete 2X2X2 factorial design. A ninth cell was later included to test the efficacy of CBI without "pills." Much has been accomplished since COMBINE's initiation. Over 70% of the intended sample has been randomized to the study treatments, reflecting gender, ethnic, geographic, and clinical diversity. Drinking assessment interviews have been completed for 84% clients at the 16-week follow-up. Two major pilot studies were successfully completed and the findings have been disseminated at conferences and in publications. The requested two-year extension will allow for the recruitment, treatment, and follow-up of the remaining participants, and allow sufficient time for data analysis and manuscript preparation. Results from the COMBINE study are expected to have a major impact on the alcohol treatment delivery system. A common protocol across each of the study sites is submitted. This reflects the cooperative process that has guided the study's efforts across the first five years of operation. However, each study site has provided site-specific information on the budget, budget justifications, listing of key personnel, consultant/consortium agreements, and human subjects sections of their respective proposals.