BEHAVIORAL/PHARMACOLOGIC TREATMENT OF ALCOHOLISM

描述：新墨西哥大学酒精中毒研究中心，物质 虐待和成瘾(CASAA)提出作为临床研究参与 多点试验中的单位(CRU)，行为/药理学相结合 酒精中毒的治疗。尽管试验方案最终将是 由试验指导委员会确定的这项提案反映了 CASAA可能会接洽该项目。我们的主(阶段)析因设计 M)试验跨越四个水平的药物(安慰剂，阿卡米松， 纳曲酮和联合用药)，有两个水平的行为 干预(认知-行为疗法和动机增强 治疗)，从手册和在项目比赛中的经验修改。 在最初的治疗期(1-3个月)之后，客户被分配到 在4-6个月期间随机接受或不接受强化治疗。 这项嵌入式试验将提供有关以下主要效果的可靠信息 更长(增强)的治疗与更短的治疗，以及关于客户的 与增强的差异化收益相关的特征 治疗。增强将保留在每个行为治疗中 模式，以避免混淆后续数据的可解释性。 不同“无反应”分类系统的预期效度 可通过此设计中的回溯分析进行测试。除了……之外 程序的可行性测试，初步(第二阶段)研究将 评估广泛预处理的主要效果和后续评估 关于治疗结果，这是一个关键问题，因为这种反应性可能会洗掉 试验治疗的主要或相互作用的影响--一种未解决的批评 在项目匹配中。第二阶段研究中的所有客户都将同时获得 阿卡米松和纳曲酮，并在2x2因子内进一步随机 设计要接受广泛或最低限度的评估，并且CBT或 相遇了。第二阶段研究设计还允许评估客户的 了解饮酒报告将通过附带面谈进行核实 影响自我报告的准确性。主要试用客户将随机 在有条件的情况下分配给治疗师，这样(与项目匹配不同)， 客户/治疗师匹配的真正测试可以在这么大的范围内进行 样本。在随机化之前，所有客户端都将接受挑战 初始用药剂量(在 少数人)，以缩小潜在的有问题的差异 药物组和安慰剂组的自然减员。自然主义的介入 将研究酗酒者互助会和其他互助组织 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.