Improving Alcoholism Treatment

描述（由申请人提供）：通过这项新的高级研究奖（K 05），主要研究者将继续追求她的临床研究职业目标，即通过1）整合临床研究的三个领域来改善酒精依赖的治疗;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。为了保持她作为临床研究和精神药理学领导者的表现，她将继续在跨学科研究中进行广泛的合作。与指导、参与研究审查和参加咨询小组有关的活动也将使科学的持续发展受益。 该研究计划的重点是联合收割机研究。未来的研究计划包括使用人类实验室范式来筛选治疗酒精依赖的新药，并将其纳入临床试验。 联合收割机研究是一项由NIAAA赞助的多中心临床试验，旨在回答有关行为和药物干预相结合的益处的问题。两种药物，纳洛酮和阿坎酸，在一些美国和欧洲的临床试验中显示出减少酗酒复发和改善禁欲的希望。两种行为治疗，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替代品。MM似乎是具有成本效益的，适合在初级保健或管理的医疗机构由非专家交付。 主要假设是，将两种药物（纳洛酮和阿坎酸）与中等强度的行为治疗（CBI）相结合将产生比强度较低的方法（例如，安慰剂和MM;阿坎酸或纳洛酮和MM）。来自11个临床研究中心的共计1375例受试者构成了这项为期16周的长期随访试验的目标样本。将符合研究标准的个体随机分配至9种药物（纳洛酮和阿坎酸）和行为治疗（MM和CBI）组合中的一种，以形成完整的2X2 X2析因设计。包括第九个单元以测试没有“药丸”的CBI的功效。“最终，这项研究的结果将对美国酗酒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.