LABORATORY MODELS OF COCAINE SELF ADMINISTRATION

可卡因自我给药的实验室模型

• 批准号: 8166772
• 负责人: Thomas Frederick Newton
• 金额: $ 2.67万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-12-01 至 2010-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8166772
• 关键词: Admission activity; Adverse event; Clinical Trials; Cocaine; Cocaine Dependence; Computer Retrieval of Information on Scientific Projects Database; Development; Disulfiram; Dose; Double-Blind Method; Enrollment; Exclusion Criteria; Funding; Grant; Human; Informed Consent; Inpatients; Institution; Laboratories; Medical center; Modeling; Outcome; Outpatients; Participant; Pharmaceutical Preparations; Phase; Placebo Control; Placebos; Predictive Value; Process; Publishing; Randomized; Research; Research Personnel; Resources; Screening procedure; Self Administration; Source; Study Subject; United States National Institutes of Health; Visit; cocaine use; design; effective therapy; payment; treatment effect; volunteer

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. After completing the informed consent process, potential volunteers will complete outpatient screening, including assessment of inclusion/exclusion criteria. This will be a double-blind, placebo-controlled, within-subjects study. The study will be conducted in 20 non-treatment seeking cocaine (COC)-dependent subjects who will reside in the Michael De Bakey VA Medical Center during two separate 5-day visits. After admission and stabilization (day 1), participants will be randomly assigned to placebo or disulfiram (250mg qd). Participants will take the study drug on days 2-4. On day 4, participants will participate in two COC self-administration in which they will have the opportunity to choose between COC (0 and 20 mg, IV) or money alternatives. On day 5, participants will be discharged from the study and will return a minimum of 7 days for enrollment and randomization to alternate disulfiram dosing conditions. During the 2nd inpatient phase, participants will receive payment for prior enrollment and staff will assess late emerging adverse events. Participants will receive payments of $50 per day provided they abstain from illicit cocaine use. We anticipate that disulfiram treatment will be associated with reduced cocaine self-administration. Results of the proposed research will provide information about the predictive value of two different laboratory models of cocaine self-administration. If results from either or both of these laboratory models are congruent with outcomes from published clinical trials of disulfiram, then further research aimed at optimizing design parameters would be indicated to further develop these approaches. The development of valid laboratory models would greatly facilitate the search for more effective treatments for cocaine dependence. To determine the effects of treatment with disulfiram on cocaine self-administration using a human laboratory model of cocaine self-administration.

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 在完成知情同意程序后，潜在志愿者将完成门诊筛查，包括评估纳入/排除标准。这将是一项双盲、安慰剂对照、受试者内的研究。这项研究将在20名非治疗寻求可卡因(COC)依赖的受试者中进行，他们将在Michael de Bakey VA医疗中心分别进行两次为期5天的访问。 在入院和稳定后(第1天)，参与者将被随机分配给安慰剂或双硫仑(250 mg，qd)。参与者将在第2-4天服用学习药物。在第4天，参与者将参加两次COC自我管理，他们将有机会在COC(0和20 mg，IV)或Money替代品之间进行选择。在第5天，参与者将从研究中出院，并将返回至少7天的登记和随机到替代的双硫仑剂量条件。在第二个住院阶段，参与者将收到先前登记的费用，工作人员将评估后期出现的不良事件。参与者将获得每天50美元的报酬，前提是他们不使用非法可卡因。 我们预计，双硫兰治疗将与减少可卡因的自我给药有关。拟议的研究结果将提供关于两种不同的可卡因自我给药实验室模型的预测价值的信息。如果这两个实验室模型中的一个或两个的结果与已公布的双硫仑临床试验的结果一致，则应进行旨在优化设计参数的进一步研究，以进一步开发这些方法。开发有效的实验室模型将极大地促进寻找更有效的可卡因依赖治疗方法。 利用可卡因自身给药的人体实验室模型，确定双硫仑治疗对可卡因自我给药的影响。