CLINICAL TRIAL OF ACUPUNCTURE FOR COCAINE DEPENDENCE

美沙酮维持治疗中的可卡因滥用是一个主要问题， 目前还没有有效的治疗方法。许多临床 报告和非对照研究表明，耳针 可能对治疗阿片类药物中的可卡因成瘾有效， 非鸦片依赖人群。然而，没有证据表明， 对照研究证实了这些疗效声明。拟议 这项研究是一项为期八周的耳针随机临床试验， 用于治疗美沙酮维持患者的可卡因依赖。 研究的具体目标有四个方面：（a）确定 耳针治疗可卡因疗效观察 （B）确定是否存在戒断 治疗期间开始的治疗维持在3个月和6个月后， （c）调查对治疗反应的性别差异;以及（d） 探索治疗结果的关键预测因素。两百二十二 可卡因依赖、美沙酮维持治疗的患者将按性别分层 并随机分配接受针灸治疗的区域， 可卡因成瘾，或两个对照组之一：针头插入 耳轮皮下注射或放松训练。所有治疗 协议是基于初步研究进行的-我们的研究 组每组中的受试者将每天接受治疗，每次5次， 每周一次，对于研究的前六周，每周三次， 最后两周通过尿液毒理学筛查验证的可卡因使用将被 主要的结果测量。 其他结果指标包括：自我- 报告的可卡因使用频率和数量， 线索，抑郁，焦虑，应对，改变动机，和复合 成瘾严重程度指数的得分。将收集随访数据 在治疗后的三个月和六个月。

Cocaine abuse in methadone maintenance programs is a major problem for which there is currently no effective treatment. A number of clinical reports and uncontrolled studies have suggested that auricular acupuncture may be efficacious for the treatment of cocaine addiction in opiate- and non-opiate-dependent populations. However, there is no evidence from controlled studies substantiating these claims of efficacy. The proposed study is an eight-week randomized clinical trial of auricular acupuncture for the treatment of cocaine dependence in methadone-maintained patients. The specific aims of the study are fourfold: (a) to determine the effectiveness of auricular acupuncture for the treatment of cocaine dependence in this patient population; (b) to determine if abstinence initiated during treatment is maintained at three- and six-month follow- up; (c) to investigate sex differences in response to treatment; and (d) to explore key predictors of treatment outcome. Two hundred and twenty-two cocaine-dependent, methadone-maintained patients will be stratified by sex and randomly assigned to receive acupuncture in regions used to treat cocaine addiction, or one of two control groups: needle insertion subcutaneously in the ear helix, or relaxation training. All treatment protocols are based on preliminary studies conducted by -our research group. Subjects in each group will receive treatment daily, five times per week, for the first six weeks of the study, and three times weekly for the last two weeks. Cocaine use, verified by urine toxicology screens, will be the primary outcome measure. Other outcome measures include: self- reported frequency and amount of cocaine use, craving in response to drug cues, depression, anxiety, coping, motivation for change, and composite scores on the Addiction Severity Index. Follow-up data will be collected at three and six months post-treatment.