LAB TRIALS TO DEVELOP MEDICATIONS FOR COCAINE DEPENDENCE--STUDY 1

开发治疗可卡因依赖药物的实验室试验——研究 1

• 批准号: 7951479
• 负责人: Bankole A Johnson
• 金额: $ 43.87万
• 依托单位: UNIVERSITY OF VIRGINIA
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-03-01 至 2010-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7951479
• 关键词: Acute; Affect; Arts; Behavioral; Clinical Research; Clinical Trials; Cocaine; Cocaine Abuse; Cocaine Dependence; Cognition; Computer Retrieval of Information on Scientific Projects Database; Crossover Design; Double-Blind Method; Effectiveness; Equilibrium; Fatigue; Female; Funding; Grant; Human; Individual; Institution; Laboratory Study; Mediating; Moods; Pharmaceutical Preparations; Physiological; Placebo Control; Positioning Attribute; Research; Research Personnel; Resources; Rewards; Safety; Solid; Source; Techniques; Testing; United States National Institutes of Health; base; male; pyranose; research study; response; topiramate

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. Topiramate, a substituted fructo-pyranose derivative, is a promising agent for the treatment of cocaine dependence, presumably because by reducing its rewarding affects associated with abuse liability. We propose an experiment using state-of-the-art human abuse liability assessment techniques to examine the subjective, behavioral, and physiological effects of cocaine both alone and in combination with topiramate. The study will be double-blind and placebo-controlled using a balanced (for sequence and position) cross-over design in male and female non treatment-seeking cocaine abusers (total N = 24). The experiment will test the hypothesis that chronically-administered topiramate will significantly reduces acute cocaine-mediated changes in subjective mood and other abuse liability assessments. As a secondary objective of this experiment, we will characterize cocaine's effects on cognition and physiological response in non-fatigued subjects during drug-taking, and determine if, and by how much, these effects are altered by topiramate. In summary, this experiment provides a proof-of-concept analysis of topiramate's ability to reduce cocaine's abuse potential. The results of this human laboratory study should provide a solid basis for planning clinical trials examining the safety and effectiveness of topiramate for the treatment of cocaine-dependent individuals.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 托吡酯是一种取代的吡喃果糖衍生物，是一种有前途的治疗可卡因依赖的药物，大概是因为它可以减少与滥用倾向相关的奖赏效应。我们提出了一项实验，使用最先进的人类滥用倾向评估技术来检查可卡因单独使用以及与托吡酯联合使用的主观、行为和生理影响。该研究将采用平衡（顺序和位置）交叉设计，对男性和女性非寻求治疗的可卡因滥用者（总 N = 24）进行双盲和安慰剂对照。该实验将验证以下假设：长期服用托吡酯将显着降低可卡因介导的主观情绪和其他滥用倾向评估的急性变化。作为本实验的次要目标，我们将描述可卡因在吸毒期间对非疲劳受试者的认知和生理反应的影响，并确定托吡酯是否会改变这些影响以及改变的程度。 总之，该实验对托吡酯减少可卡因滥用潜力的能力进行了概念验证分析。 这项人体实验室研究的结果应该为规划临床试验提供坚实的基础，以检验托吡酯治疗可卡因依赖者的安全性和有效性。