COCAINE DEPENDENCE--MEDICATION AND BEHAVIORAL TREATMENTS

可卡因依赖有严重的后果，事实证明很难 请客。我们将进行三次严格、创新、可控的用药 在已确定的亚群中进行试验。 药物和剂量将是主要的自变量。氟西汀(0或 40 mg)将在78名被诊断为抑郁症(DSM-IV)的患者中进行检查，并 对可卡因上瘾。40毫克的氟西汀，已经被发现是好的 在我们之前的研究中是耐受的，尽管对可卡因无效 依赖本身。将在80%的可卡因中检测到双硫胺(0或375毫克) 酗酒的依赖患者。一些数据表明， 双硫胺，但研究需要特别的预防措施，因为已知 “兴奋剂”和双硫兰之间的相互作用。激动剂(替代物) 模型已经成为最成功的药物用药方法 依赖(如美沙酮；尼古丁)。我们检查了哌醋甲酯和 现在将检查D-苯丙胺的缓释对可卡因的依赖- 仅在使用人体实验室测试的双盲试验中 为试验做的诊断工作。 药物治疗将在手动驱动的行为治疗基线上进行研究 通过(1)电话筛查，(2)医疗/行为/精神科收容； (3)2周的稳定和剂量增加；(4)12周的药物试验 在第8周为研究3提供特别安全规定；(V)2周 终止期；(Vi)3个月随访。从属措施包括： 每周两次尿检，尿液滞留，接受必要的治疗 要素，以及每周、每月和在 后续行动。分配将是随机的。患者将基于分层 关于吸食毒品的筛查结果。氟西汀试验和d-苯丙胺 试验，但不是双硫兰试验，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 具有专家数据分析方法的创新试验是主要优势 中心的一部分。这些研究在概念和技术上都很强大， 适当考虑安全问题，并将为NIDA和 目标人群中的治疗-药物组合领域。

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.