Medication/Psychotherapy Tailored to Patient Resources

描述（由申请人提供）：本申请寻求两年的资金，以完成组合及其辅助成本效益和治疗反应研究的遗传预测因子。 COMBINE研究始于1997年，旨在回答有关结合的益处的问题。 行为和药物干预。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例受试者构成目标样本。符合研究标准的个体被随机分配到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2X2X2析因设计。后来，第九个细胞被包括在内，以测试没有“药丸”的CBI的功效。" 自COMBINE成立以来，已经取得了很大成就。超过70%的预期样本已随机分配至研究治疗组，反映了性别、种族、地理和临床多样性。 在16周的随访中，84%的患者完成了饮酒评估访谈。两项主要的试点研究已顺利完成，研究结果已在会议上和出版物中传播。请求的两年延期将允许招募、治疗和随访剩余参与者，并有足够的时间进行数据分析和手稿准备。COMBINE研究的结果预计将对酒精治疗输送系统产生重大影响。 提交每个研究中心的共同方案。这反映了合作进程，该进程指导了这项研究头五年的工作。但是，每个研究中心都提供了关于预算、预算理由、关键人员列表、顾问/联合体协议和各自提案中人类受试者部分的研究中心特定信息。

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 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. 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.