CLINICAL TRIAL: INTERACTIONS BETWEEN PROGESTERONE AND COCAINE

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。 这项研究的目的是探索烟熏可卡因和外源性黄体酮之间的特定相互作用。一种假设是，女性在卵泡期服用外源性黄体酮会减少对可卡因和可卡因自身给药的主观反应。黄体酮或安慰剂治疗将在月经期间给予，当血浆雌二醇和黄体酮浓度通常较低时。月经周期的这个早期卵泡阶段提供了一个机会来研究外源性黄体酮的影响，同时最小化内源性雌二醇和黄体酮的潜在混杂影响。 对男性的假设是，黄体酮将减弱对可卡因的欲望和使用。这项研究的一个具体目的是在实验室模型中表征黄体酮对烟熏可卡因的生理、主观和增强效应的剂量相关影响。健康的可卡因依赖女性受试者将在月经早期(连续两个月经周期)进入GCRC，并开始口服黄体酮，Bid。男性受试者将连续两个月同时进入GCRC，并按女性接受剂量。所有受试者都将经历一个适应阶段，在这一阶段，他们将被介绍给该方案和一剂可卡因。在连续两天(3天和4天)的实验过程中，他们将被给予一定剂量的烟熏可卡因，并可以选择通过做计算机数学测试来赚取5枚代币。然后，他们可以用这些代币(最多5枚)换取5美元或一剂烟熏可卡因。将监测生理参数，GCRC护理人员将在实验期间建立静脉输液并抽血。将有一名内科医生在场。这项研究将使黄体酮的剂量效应得以研究。使用的可卡因剂量与以前关于GCRC的研究相同。

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.