CLINICAL TRIAL: INTERACTIONS BETWEEN PROGESTERONE AND COCAINE

临床试验：黄体酮和可卡因之间的相互作用

• 批准号: 7951657
• 负责人: SHEILA Mary SPECKER
• 金额: $ 3.48万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-12-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7951657
• 关键词: Attenuated; Blood; Clinical Research; Clinical Trials; Cocaine; Computer Retrieval of Information on Scientific Projects Database; Computers; Dose; Estradiol; Female; Funding; Grant; Institution; Laboratories; Menstrual cycle; Menstruation; Modeling; Monitor; Nursing Staff; Oral; Phase; Physicians; Physiological; Placebos; Plasma; Progesterone; Protocols documentation; Research; Research Personnel; Resources; Sampling; Self Administration; Smoke; Source; Testing; Time; United States National Institutes of Health; Woman; cocaine use; male; men; proliferative phase Menstrual cycle; research study; response

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. The purpose of this study is to explore specific interactions between smoked cocaine and exogenously administered progesterone. One hypothesis is that exogenous progesterone, adminstered during the follicular phase in women will reduce subjective responses to cocaine as well as cocaine self-administration. Progesterone or placebo treatment will be given during their menses when plasma estradiol and progesterone concentrations are normally low. This early follicular phase of the menstrual cycle provides an opportunity to investigate the effects of exogenously administered progesterone while minimizing the potential confounding influence of endogenous estradiol and progesterone. The hypothesis for men is that progesterone will attenuate the desire for and use of cocaine. A specific aim of the study will be to characterize the dose-related effects of progesterone on the physiological, subjective and reinforcing effects of smoked cocaine in a laboratory model. Healthy cocaine dependent female subjects will be admitted to the GCRC early in their menses (during two consecutive menstrual cycles) and begin oral progesterone, given BID. Male subjects will be admitted to the GCRC at the same time two consecutive months and receive dosing as per the females. All subjects will undergo an adaption phase where they will be introduced to the protocol and a dose of cocaine. During the experimental sessions on 2 consecutive days (3 & 4) they will be given a sample dose of smoked cocaine and have the option to earn 5 tokens from doing a computer math test. They may then exchange these tokens (up to 5) for money (5.00) or a dose of smoked cocaine. Physiologic parameters will be monitored and GCRC nursing personnel will establish IV's and draw blood during the experiment. A physician will be in attendance. This study will allow dose-effects of progesterone to be studied. The doses of cocaine used are the same as in previous studies on the GCRC.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 这项研究的目的是探索熏制可卡因和外源施用孕酮之间的特定相互作用。 一个假设是，在卵泡期间，女性构成的外源孕酮将减少对可卡因以及可卡因自我给药的主观反应。 当血浆雌二醇和孕酮浓度通常低时，孕酮或安慰剂治疗通常会在月经期间进行。 月经周期的早期卵泡期为研究外源给药的孕酮的影响提供了一个机会，同时最大程度地减少了内源性雌二醇和孕激素的潜在混杂影响。 男性的假设是孕酮会减轻对可卡因的渴望和使用。该研究的一个具体目的是表征孕酮对熏制可卡因在实验室模型中的生理，主观和增强作用的剂量相关作用。 健康依赖性的女性受试者将在月经的早期（在两个连续的月经周期）开始接受GCRC，并开始口服孕激素。男性受试者将连续两个月接纳GCRC，并根据女性接受给药。 所有受试者将经历适应阶段，将其引入方案和可卡因剂量。 在连续2天（3＆4）的实验性会话中，他们将获得样本剂量的熏制可卡因，并可以选择通过进行计算机数学测试来赚取5个令牌。 然后，他们可以将这些令牌（最多5）换成金钱（5.00）或一剂烟熏可卡因。 将监测生理参数，GCRC护理人员将在实验过程中建立IV并吸收血液。 医师将出席。 这项研究将允许研究孕酮的剂量效应。 使用的可卡因剂量与以前关于GCRC的研究相同。