POST TREATMENT EFFECTS OF NALTREXONE

申请人摘要：申请人的长期研究目标 研究者的目的是最大限度地提高治疗的临床效果， 酒精中毒 本方案的具体目的是比较3个月和6个月 纳洛酮（NTX）作为两种范围不同的心理治疗的辅助药物 和强度。 这些治疗的效果将与患者一起评估 他们的社会心理需求和社会心理资源不同， 处理方式和对酒精的渴望程度。 在这项随机临床试验中，每日50 mg NTX和 增强治疗（MET），或更全面的广谱 将在12周内提供治疗（BST）（I期）。 在第一阶段之后， 在两种心理治疗条件下接受NTX的组中， 以双盲方式交叉至安慰剂。 每日用药将继续 3个月（第二阶段）。 MET将在第一阶段结束， 那些有更大的心理社会需求和更少的心理社会资源的患者 可以在第二阶段继续进行BST。 药物治疗和BST结束 然后对患者进行为期12个月的随访（III期）。 所有治疗阶段的结果指标包括：1）饮酒结果 (time第一次饮酒; %戒酒天数; %酗酒天数）; 2）阴性 饮酒的后果; 3）心理社会适应。 总的来说，预计最佳的一揽子处理方案将是 针对患者的大多数独特的心理需求， 解决酒精依赖的生物学方面， 药物管理。

APPLICANT'S ABSTRACT: The long-term research goal of the applicant investigators is to maximize the clinical effectiveness of treatment for alcoholism. The specific aims of this protocol are to compare 3 and 6 months of naltrexone (NTX) as an adjunct to two psychotherapies that differ in scope and intensity. The effect of these treatments will be assessed with patients who differ in their psychosocial need and psychosocial resources at their disposal, and in their level of cravings for alcohol. In this randomized clinical trial, 50 mg of NTX daily and either Motivational Enhancement Treatment (MET), or the more comprehensive Broad Spectrum Treatment (BST), will be provided over 12 weeks (Phase I). Following Phase I, half of the group receiving NTX in both psychotherapy conditions will crossover to placebo, in double-blind fashion. Daily medication will continue for an additional 3 months (Phase II). MET will terminate in Phase I, while those patients with greater psychosocial need and fewer psychosocial resources may continue in BST during Phase II. Medication and BST terminate at the end of Phase II, and patients are then followed for 12 months (Phase III). Outcome measures during all treatment phases include: 1) drinking outcomes (time to first drink; % days abstinent; % heavy drinking days); 2) negative drinking consequences; and 3) psychosocial adjustment. Overall, it is anticipated that the optimum treatment package will be one that targets the majority of the unique psychosocial needs of the patient while addressing the biological aspects of alcohol dependence via effective medication management.