Progesterone for Postpartum Cocaine Relapse

描述(申请人提供)：临床前数据显示，雌激素增加了刺激剂自我给药的可能性；黄体酮具有相反的作用，可以逆转雌二醇的作用。有限的人体数据显示，黄体酮可以减轻女性对兴奋剂的渴望和主观上的积极反应。以循环孕酮水平高为特征的妊娠与物质使用量的减少有关。不幸的是，分娩后毒品使用量再次增加。随着孕酮水平的升高，孕期药物使用量逐渐减少，而孕酮水平下降时，分娩后药物使用量增加，这表明孕酮可能会影响药物使用。这项申请寻求资金，以获得关于孕酮治疗是否减少产后妇女可卡因使用的初步数据。孕酮治疗将抵消分娩过程中黄体酮的损失。因此，我们提出了一项双盲、随机、安慰剂对照试验，该试验将获得口服微粒化孕酮对有可卡因依赖或滥用史的产后妇女的疗效的初步数据。我们将随机选择50名产后妇女，在三个月内每周对她们进行评估，然后在试验结束后三个月再次进行评估。参与者还将接受药物使用的认知行为咨询。结果测量包括在试验期间随机进入两种(安慰剂或黄体酮)条件之一的女性的天数和可卡因使用量。 公共卫生相关性：以循环孕酮水平高为特征的怀孕与物质使用的减少有关。这项申请寻求资金，以获得关于孕酮治疗是否减少产后妇女可卡因使用的初步数据。孕酮治疗将抵消分娩过程中黄体酮的损失。因此，我们提出了一项双盲、随机、安慰剂对照试验，该试验将获得口服微粒化孕酮对有可卡因依赖或滥用史的产后妇女的疗效的初步数据。

DESCRIPTION (provided by applicant): Pre-clinical data show that estrogen increases the likelihood of stimulant self- administration; progesterone has the opposite effect and can reverse the effect of estradiol. Limited human data show that progesterone attenuates cravings for and subjective positive response to stimulants in women. Pregnancy, which is characterized by high circulating progesterone levels, is associated with decreased substance use. Unfortunately, drug use increases again after delivery. The incremental decrease in drug use over the course of pregnancy as progesterone levels increase, and the escalation in drug use after delivery when progesterone levels drop, suggests the possibility that progesterone influences drug use. This application seeks funding to obtain preliminary data on whether treatment with progesterone, which would counterbalance the progesterone lost with parturition, reduces cocaine use among postpartum women. Accordingly, we propose a double-blind, randomized, placebo-controlled trial that would obtain preliminary data on the efficacy of oral micronized progesterone for postpartum women with a history of cocaine dependence or abuse. We would randomize 50 postpartum women and evaluate them weekly for three months and then again 3 months after the end of the trial. Participants would also receive cognitive-behavioral counseling for drug use. Outcome measures include the percentage of days and amount of cocaine use during the trial for women randomized to one or the other of the two (placebo or progesterone) conditions. PUBLIC HEALTH RELEVANCE: Pregnancy, which is characterized by high circulating progesterone levels, is associated with decreased substance use. This application seeks funding to obtain preliminary data on whether treatment with progesterone, which would counterbalance the progesterone lost with parturition, reduces cocaine use among postpartum women. Accordingly, we propose a double-blind, randomized, placebo- controlled trial that would obtain preliminary data on the efficacy of oral micronized progesterone for postpartum women with a history of cocaine dependence or abuse.