NEW MEDICATIONS FOR COCAINE AND OPIATE DEPENDENCE

描述(申请人摘要)： 可卡因依赖和鸦片+可卡因依赖是重要的公众 健康问题。事实证明，这些疾病很难治疗。新药 必须进行检查，尽管行为环境因素可以 预计与药物联合作用，影响结果。 作用于多巴胺通路的药物直接或间接改变可卡因 临床前和人体研究中的摄入量和其他措施。这样的一个 药物利坦色林可能对可卡因依赖有效。 是一种治疗鸦片类药物的有效药物 依赖。美沙酮+利坦色林可能对 治疗并发的鸦片类可卡因依赖。 用药效果可以通过设定因素来调节。访问频率 是一种我们已经证明与药物联合作用的情况。 通过应急管理程序增强的行为治疗也 可能与药物相互作用。这些研究，就像我们之前的工作一样， 将考察药物和治疗元素的联合作用 使用干预措施的合理组合。 我们提出了两组平行研究。基准行为- 心理干预将是一种高度结构化的专业 给予治疗(2次/周)。在研究1和2中，可卡因治疗 药物将是利他色林(安慰剂，5或10毫克)。在研究3和 4、瑞坦色林(0、5或10毫克)+美沙酮(1.1毫克/公斤) 适用于可卡因+阿片类药物依赖患者。Ritanserin 成分将是双盲安慰剂对照。将会有150个 患者在每项研究中随机分配。可卡因依赖研究 (1和2)将进行12周和鸦片+可卡因依赖研究(3和 4)将是26周。所有研究包括自我报告、标准医学 通过艾滋病毒和结核病检测以及精神评估进行检查。阶段 包括：同意、服药、两周稳定、治疗和研究结束 疗程3个月，随访3个月。主要自变量有 用药和剂量与就诊频率的设置/治疗变量 (2或5次/周)，或标准行为VS强化治疗。 在强化治疗中，患者将有机会获得 补充性增强剂取决于药物筛查结果 连续几周。主要因变量是药物使用(2/wk尿 筛分)和保留率，以及其他二次分析。 拟议的研究将仔细进行临床试验。 研究新药和调节药物效果的因素 治疗结果。它们是我们正在进行的工作的逻辑延伸和 补充我们的其他研究。

DESCRIPTION (Applicant's Abstract): Cocaine dependence and opiate+cocaine dependence are important public health problems. They have proven difficult to treat. New medications must be examined, though behavioral-environmental factors can be expected to act jointly with medication, influencing outcome. Drugs that act at dopamine pathways directly or indirectly alter cocaine intake and other measures in pre-clinical and human studies. One such medication, ritanserin, may be effective for cocaine dependence.Methadone is an effective, well understood medication for treatment of opiate dependence. Methadone+ritanserin may be particularly effective in treating concurrent opiate cocaine dependence. Medication effects can be modulated by setting factors. Visit frequency is a condition we have demonstrated acts jointly with medication. Behavioral therapy enhanced with contingency management procedures also may interact with medication. These studies, like our earlier work, will examine the joint action of medications and treatments elements using logical combinations of interventions. We propose two sets of parallel studies. The baseline behavioral- psychological intervention will be a highly structured professionally delivered therapy (2/wk). In Studies 1 and 2, the cocaine treatment medication will be ritanserin (placebo, 5, or 10 mg). In Studies 3 and 4, ritanserin (0, 5, or 10 mg) + methadone (at 1.1 mg/kg) will be administered to cocaine + opiate dependent patients. Ritanserin components will be double- blind placebo-controlled. There will be 150 patients in each study randomly assigned. Cocaine dependence studies (1 and 2) will be 12 weeks and opiate+cocaine dependence studies (3 and 4) will be 26 weeks. All studies include self-report, standard medical examination with HIV and TB tests, and psychiatric evaluations. Phases are: consent, intake, 2 week stabilization, treatment, and study end periods, with a 3 month follow-up. Major independent variables are medication and dose with setting/treatment variables of visit frequency (2 or 5/week), or standard behavioral vs reinforcer enhanced therapy. In the enhanced therapy, patients will have the opportunity to obtain supplementary reinforcers contingent on drug screen results over successive weeks. Major dependent variables are drug use (2/wk urine screens) and retention, with other secondary analyses. The proposed studies will be carefully conducted clinical trials examining new medications and factors modulating medication effects and treatment outcome. They are logical extensions of our ongoing work and complement our other studies.