RITANSERIN AND RELAPSE PREVENTION FOR COCAINE DEPENDENCE

描述(申请人摘要)： 这项双盲、安慰剂对照的临床研究将评估 瑞坦色林和两种手导疗法治疗可卡因 依赖。198名可卡因依赖患者完成为期14天的 住院治疗计划将随机分配到六个人中的一个 用3×2析因设计比较药物组的处理细胞 (安慰剂，5毫克，10毫克)和心理治疗(预防复发，标准 药物咨询)。为期12周的门诊治疗将包括两次 每周一次的个人心理治疗接触。预防复发的技术 将强调应对技能培训，处理吸毒事件，以及 改变一般的生活方式以保持节欲。标准药品 咨询将是非指导性的和支持性的。吸毒史，成瘾 将测量严重程度、心理社会功能和应对技能。 在预处理处。在治疗期间，每两周进行一次尿检。 与每周对可卡因渴望的测量一起进行，Side 效果和情绪状态。短期结果将在以下方面进行评估 终止治疗，随后在一年内重复评估 检查治疗耐久性的期限。主要因变量 将包括可卡因的使用(尿检和自我报告)、治疗 出勤率、保留率和服药依从性。药物使用 将根据以下指标分析结果：(A)可卡因比例-- 尿液药物筛查呈阳性；(B)持续时间 戒除；(C)可卡因渴求评级；(D)复吸率 非法毒品。治疗改善的其他指数将包括： (A)ASI对问题严重性的评级；(B)在 情景能力测验；(C)心理社会功能(即， 抑郁、社会支持、感受到的压力)。我们预测 在与以下方面相关的结果指标上，利坦色林将优于安慰剂 吸食可卡因。此外，治疗的类型将与 药物对大多数结果指标的影响。具体来说， 接受利他色林和复发预防治疗的受试者将会减少 可能会复发到经常使用可卡因，并将报告 更好的短期和长期心理社会功能 对照组受试者。最后，这个项目将建立 一种药物治疗-心理治疗联合模式，以支持对 治疗可卡因依赖的药物开发。

DESCRIPTION (Applicant's Abstract): This double-blind, placebo-controlled clinical study will evaluate ritanserin and two manually-guided therapies in the treatment of cocaine dependence. Cocaine dependent patients (N = 198) completing a 14-day inpatient treatment program will be randomly assigned to one of six treatment cells in a 3 X 2 factorial design comparing drug group (placebo, 5 mg, 10 mg) and psychotherapy (relapse prevention, standard drug counseling). The 12-week outpatient treatment will involve twice weekly individual psychotherapy contacts. Relapse prevention techniques will emphasize coping skills training, handling drug use episodes, and general lifestyle changes to maintain abstinence. Standard drug counseling will be nondirective and supportive. Drug history, addiction severity, psychosocial functioning, and coping skills will be measured at pretreatment. During treatment, biweekly urinalysis testing will bs conducted, along with weekly measurement of cocaine craving, side effects, and mood state. Short-term outcome will be assessed at treatment termination, followed by repeated assessments over a 1-year period to examine treatment durability. Primary dependent variables will include cocaine use (urine screen and self-report), treatment attendance, retention rates, and medication compliance. Drug use outcomes will be analyzed according to: (a) proportion of cocaine- positive urine drug screens; (b) duration of continuous periods of abstinence; (c) cocaine craving ratings; (d) rates of relapse to other illicit drugs. Other indices of treatment improvement will include: (a) ASI ratings of problem severity; (b) coping scores on the Situational Competency Test; (c) psychosocial functioning (i.e., depression, social support, perceived stress). We predict that ritanserin will be superior to placebo on outcome measures related to cocaine consumption. Furthermore, type of therapy will interact with the effect of medication on most outcome measures. Specifically, subjects receiving ritanserin and relapse prevention therapy will be less likely to experience a relapse to regular cocaine use and will report better short- and long-term psychosocial functioning compared to subjects in the control groups. Finally, this project will establish a joint pharmacotherapy- psychotherapy model to support research on medications development for cocaine dependence.