Improving Alcoholism Treatment

描述(申请人提供)：凭借这一新的高级研究奖(K05)，首席研究员将继续追求她的临床研究生涯目标，通过1)整合临床研究的三个领域：心理治疗干预、药物治疗开发、人类生物行为实验室研究，2)培训新的临床研究人员，以及3)教育治疗社区了解新的治疗方法。她还将对酒精和烟草的相互作用进行研究。为了保持她在临床研究和精神药理学方面的领先地位，她将继续在跨学科研究方面进行广泛的合作。科学的持续增长也将受益于与指导和参与研究审查和咨询小组参与有关的活动。 研究计划的重点是结合学习。未来的研究计划包括使用人体实验室范例来筛选治疗酒精依赖的新药，并将这些药物用于临床试验。联合研究是一项由NIAAA赞助的多点临床试验，旨在回答有关行为和药物干预相结合的益处的问题。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。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个临床地点的1375名受试者组成了这项为期16周的长期随访试验的目标样本。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。其中包括第九个单元，用于测试不使用“药丸”的CBI的疗效。最终，这项研究的结果将对美国酒精中毒的治疗产生重要影响。

DESCRIPTION (provided by applicant): With this new Senior Research Award (K05), the principal investigator will continue to pursue her clinical research career goal of improving the treatment of alcohol dependence by 1) integrating three domains of clinical research; psychotherapeutic interventions, pharmacotherapy development, human bio-behavioral laboratory studies, 2) training new clinical researchers, and 3) educating the treatment community about new treatments. She will also conduct research on alcohol and tobacco interactions. In order to sustain her performance as a leader in clinical research and psychopharmacology, she will continue extensive collaborations in interdisciplinary research. Continued scientific growth will benefit as well from activities related to mentoring and participation in research review and advisory group participation. The research plan is focused on the COMBINE Study. Plans for future research include using human laboratory paradigms to screen new medications for alcohol dependence and to take these into clinical trials. The COMBINE study is a NIAAA sponsored multi-site clinical trial designed 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 Behavioral 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 for this 16 week trial with long-term follow-up. Individuals meeting study criteria are 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 is included to test the efficacy of CBI without "pills." Ultimately, the results of this study will have important implications for the treatment of alcoholism in the United States.