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， 目前尚无有效的治疗方法。 的一个困难 证明了这组药物的疗效， 患者可能是可卡因滥用美沙酮对象通常 参与临床试验的患者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 通过招募两名患者来解决患者动机问题， 不同阶段的禁欲开始，并通过调查 这些阶段和两种不同剂量的马吲哚之间的相互作用。 198例美沙酮维持治疗的可卡因患者样本 依赖性将根据禁欲阶段进行分层 （a）在进入时滥用可卡因的患者 研究，和（B）患者戒断可卡因使用一至 四周。 然后他们将被随机接受低剂量 马吲哚（1 mg）、高剂量马吲哚（8 mg）或安慰剂治疗12周。 研究的具体目的是：确定马吲哚（1 mg或 8毫克）比安慰剂更有效的治疗可卡因 依赖性;以确定患者在不同阶段的禁欲 开始（目前使用与禁欲1-4周）是 对治疗有不同的反应;以确定是否存在 按戒断启动相互作用阶段划分的马吲哚;表征 患者在入组时处于不同的禁欲开始阶段， 研究，以评估沿着各个方面发生的变化， 治疗;并探索治疗结果的其他潜在预测因素 (e.g.,反社会人格障碍，抑郁症，性）。 咖啡使用， 通过每周三次尿液毒理学筛查证实， 主要结果测量。 其他指标包括：自我报告的频率 可卡因使用量，线索反应，变化阶段，自我 代表性，抑郁和成瘾的综合得分 严重度指数。 将在术后6个月收集随访数据， 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.