BEHAVIORAL/PHARMACOLOGIC TREATMENT OF ALCOHOLISM

描述：新墨西哥州大学酒精中毒中心，物质 滥用和成瘾（CASAA）提供参与临床研究 多中心试验中的单位（CRU），联合行为/药理学 治疗酒精中毒。尽管试验方案最终将 由审判指导委员会决定，这一建议反映了如何 CASAA可能会接近该项目。我们的主因子设计（阶段 M）试验跨越四个水平的药物治疗（安慰剂，阿坎酸， 纳洛酮和联合药物）与两个水平的行为 干预（认知行为疗法和动机增强 治疗），两者都是根据手册和Project MATCH中的经验修改的。 在最初的治疗期（1-3个月）之后， 在4-6个月期间随机接受或不接受增强治疗。 这项嵌入式试验将提供关于以下主要影响的可靠信息： 较长（增强）治疗与较短治疗，以及关于客户 与从增强的 治疗在每次行为治疗中将保留增强 方式，以免混淆后续数据的可解释性。 各种“无应答者”分类系统的前瞻性有效性 可以通过本设计中的回顾性分析进行测试。除了 程序的可行性测试，初步（第二阶段）研究将 评价广泛的预处理和随访评估的主要效果 这是一个至关重要的问题，因为这种反应可能会影响治疗效果， 试验治疗的主要或相互作用效应-未解决的批评 在Project Match。第二阶段研究的客户将获得 阿坎酸和纳曲酮，并在2x2析因内进一步随机化 设计接受广泛或最低限度的评估，以及CBT或 MET. II期研究设计还允许评估客户的 了解饮酒报告将通过间接访谈进行核实 影响自我报告的准确性。主要试用客户将随机 分配给条件内的治疗师，以便（与项目匹配不同）， 客户/治疗师匹配的真正测试可以在这个大的 sample.随机化前，所有受试者将接受 初始药物剂量（在一种情况下产生立即的厌恶作用） 少数人），以减少潜在的问题差异 药物组和安慰剂组的损耗。自然主义参与 匿名戒酒会和其他互助组织将被研究， 确定它是否与这些治疗相互作用，以提高结果。

DESCRIPTION: The University of New Mexico's Center on Alcoholism, Substance Abuse, and Addictions (CASAA) offers to participate as a Clinical Research Unit (CRU) in the multisite trial, Combined Behavioral/Pharmacological Treatment of Alcoholism. Although the trial protocol will ultimately be determined by the trial's Steering Committee, this proposal reflects how CASAA might approach the project. Our factorial design for the main (Phase M) trial crosses four levels of medication (placebo, acamprosate, naltrexone, and combined medications) with two levels of behavioral intervention (Cognitive-Behavioral Therapy and Motivational Enhancement Therapy), both modified from manuals and experience in Project MATCH. Following the initial treatment period (months 1-3), clients are assigned at random to receive or not receive augmented treatment during months 4-6. This embedded trial will provide reliable information about main effects of longer (augmented) versus shorter treatment, and about client characteristics associated with differential benefit from augmented treatment. Augmentation will be retained within each behavioral treatment modality, so as not to confound the interpretableness of follow-up data. The prospective validity of various 'nonresponder' classification systems can be tested via retrospective analyses within this design. In addition to feasibility testing of procedures, the preliminary (Phase II) study will evaluate the main effect of extensive pretreatment and follow-up assessment on treatment outcomes, a crucial issue because such reactivity could wash out main or interaction effects of trial treatments - a critique unaddressed in Project MATCH. Clients in the Phase II study will all be given the both acamprosate and naltrexone, and further randomized within a 2x2 factorial design to receive either extensive or minimal assessment, and, either CBT or MET. The Phase II study design also allows evaluation of whether a client's knowledge that drinking reports will be verified via collateral interviews affects the accuracy of self-reports. Main trial clients will be randomly assigned to therapists within conditions, so that (unlike in Project MATCH), true tests of client/therapist matches can be conducted in this large sample. Prior to randomization, all clients will be challenged with an initial medication dose (which exerts immediate aversive effects in a minority of individuals), to diminish potentially problematic differential attrition from medication and placebo groups. Naturalistic involvement in Alcoholics Anonymous and other mutual help organizations will be studied to determine whether it interacts with these treatments to enhance outcomes.