HIGH AND LOW DOSE MAZINDOL FOR COCAINE ABUSE

美沙酮维持患者中的可卡因滥用是一个问题， 目前还没有有效的治疗方法。有一个困难是 在这组患者中显示药物治疗药物的有效性 患者可能是滥用可卡因的美沙酮受试者通常 参加临床试验的人停止滥用的动机较低 可卡因。在拟议的马吲哚双盲研究中，我们计划 通过在两个月内招募患者来解决患者的积极性问题 禁欲启动的不同阶段，并通过调查 这三个阶段与两种不同剂量的马吲哚之间的相互作用。 198例服用美沙酮并有记录的可卡因受试者样本 依赖将根据禁欲的阶段进行分层 启蒙：(A)病人在进入医院时滥用可卡因 研究，以及(B)戒除可卡因一至五个月的患者 四周。然后，他们将被随机分成两组，分别接受低剂量 马吲哚(L毫克)、大剂量马吲哚(8毫克)或安慰剂，疗程12周。 这项研究的具体目的是：确定马吲哚(1毫克或 8毫克)比安慰剂治疗可卡因更有效 依赖；以确定处于不同戒断阶段的患者 入门(目前使用禁欲1-4周)是 对治疗有不同的反应；以确定是否有 马吲哚通过阶段性戒断启动相互作用； 处于不同禁欲阶段的患者进入戒酒中心 研究，以评估沿不同维度发生的变化 治疗；以及探索治疗结果的其他潜在预测因素 (例如，反社会人格障碍、抑郁、性)。可卡因的使用， 通过每周三次尿液毒理筛查证实的是 主要结果衡量标准。其他衡量标准包括：自我报告频率 以及可卡因使用量、线索反应性、变化阶段、自我 成瘾的表征、抑郁和综合得分 严重性指数。后续数据将在6个月后收集 治疗。

Cocaine abuse among methadone-maintained patients is a problem for which there is currently no effective treatment. One difficulty in demonstrating efficacy for pharmacotherapeutic agents in this group of patients may be that cocaine-abusing methadone subjects typically enrolled in clinical trials possess low motivation to stop abusing cocaine. In the proposed double-blind study of mazindol we plan to address the issue of patient motivation by enrolling patients at two different stages of abstinence initiation, and by investigating the interaction between these stages and two different doses of mazindol. A sample of 198 methadone-maintained subjects with documented cocaine dependence will be stratified on the basis of stage of abstinence initiation: (a) patients abusing cocaine at time of entry into the study, and (b) patients abstinent from cocaine use for between one and four weeks. They will then be randomized to receive either low-dose mazindol (l mg), higher dose mazindol (8 mg), or placebo for 12 weeks. The specific aims of the study are: to determine if mazindol (1 mg or 8 mg) is more effective than placebo for the treatment of cocaine dependence; to determine if patients at different stages of abstinence initiation (currently using vs. abstinent for 1-4 weeks) are differentially responsive to treatment; to determine if there is a mazindol by stage of abstinence initiation interaction; to characterize patients at different stages of abstinence initiation at entry into the study, to assess changes that occur along various dimensions with treatment; and to explore other potential predictors of treatment outcome (e.g., Antisocial Personality Disorder, depression, sex). Cocaine use, verified by three times weekly urine toxicology screens will be the primary outcome measure. Other measures include: self-reported frequency and amount of cocaine use, cue reactivity, stage of change, self- representation, depression, and composite scores on the Addiction Severity Index. Follow-up data will be collected at six months post- treatment.