COCAINE DEPENDENCE--MEDICATION AND BEHAVIORAL TREATMENTS

可卡因依赖具有严重的后果，并已证明难以 请客我们将进行三种严格的创新的控制药物治疗 在确定的亚群中进行试验。 药物和剂量将是主要的独立变量。氟西汀（0或 40 mg）将在78名诊断为抑郁症（DSM-IV）的患者中进行检查， 可卡因依赖者40毫克的氟西汀，已被发现是很好的 在我们以前的研究中，它是可以耐受的，尽管对可卡因无效。 依赖本身。将在80例可卡因中检查双硫仑（0或375 mg） 依赖酒精的病人一些数据表明， 双硫仑，但由于已知的 “兴奋剂”和双硫仑之间的相互作用。激动剂（替代品） 模型已经成为最成功的药物治疗方法， 依赖（如美沙酮;尼古丁）。我们检查了哌醋甲酯， 现在将检查持续释放的D-安非他明对可卡因的依赖性- 仅使用人体实验室测试作为部分的双盲试验中的受试者 临床试验的诊断报告 将在手动驱动的行为治疗基线上研究药物 （i）电话筛查，（ii）医疗/行为/精神病摄入; (iii)2周稳定和剂量启动;（iv）12周药物试验 在第8周时具有研究3的特殊安全性规定;（v）第2周 终止期;（vi）3个月随访。相关措施包括： 每周两次尿液筛查、尿潴留、参加所需治疗 元素，并每周，每月和在 随访 分配将是随机的。患者将根据 摄入药物筛查结果氟西汀试验和d-安非他明 试验，但不是双硫仑试验，将是双盲的（根据审查）。 这些研究是我们工作的直接延伸。我们的指挥能力 采用专家数据分析方法的创新试验是一个主要优势 的中心。这些研究在概念上和技术上都很强， 适当考虑安全问题，并将产生重要的数据，NIDA和 关于目标人群中治疗药物组合的领域。

Cocaine dependence has serious consequences and has proven difficult to treat. We will conduct three rigorous, innovative, controlled medication trials in identified subpopulations. Medication and dose will be major independent variables. Fluoxetine (0 or 40 mg) will be examined in 78 patients diagnosed as depressed (DSM-IV) and cocaine dependent. 40 mg of fluoxetine, has been found to be well tolerated in our previous studies, though not effective for cocaine dependence per se. Disulfiram (0 or 375 mg) will be examined in 80 cocaine dependent patients who abuse alcohol. Some data suggest utility of disulfiram but research is needed with special precautions due to known interaction between 'stimulants' and disulfiram. Agonist (replacement) models have been the most successful medication approaches for drug dependence (e.g. methadone; nicotine). We examined methylphenidate and will now examine sustained release d-amphetamine for cocaine dependence- only subjects in a double blind trial using human laboratory tests as part of the diagnostic work-up for the trial. Medications will be studied on a manual driven behavioral therapy baseline with (i) telephone screening, (ii) medical/behavioral/psychiatric intake; (iii) 2 weeks stabilization and dose run-up; (iv) 12 week medication trial with special safety provisions for study 3 at week 8;(v) 2 week termination period; (vi) 3 month follow-up. Dependent measures include: twice weekly urine screens, retention, attendance at required treatment elements, and self-report measures obtained weekly, monthly, and at follow-up. Assignment will be random. Patients will be stratified based on intake drug screen results. The fluoxetine trial and d-amphetamine trials, but not the disulfiram trial, will be double blind (per reviews). These studies are direct extensions of our work. Our ability to conduct innovative trials with expert data analytic approaches is a major strength of the Center. These studies are conceptually and technically strong, with due regard for safety issues and will yield important data to NIDA and the field regarding therapy-medication combinations in target populations.