Progesterone for Postpartum Cocaine Relapse

描述（由申请人提供）：临床前数据显示雌激素增加自我给药的可能性；黄体酮有相反的作用，可以逆转雌二醇的作用。有限的人类数据表明，黄体酮可以减轻女性对兴奋剂的渴望和主观积极反应。妊娠，其特点是高循环孕酮水平，与减少药物使用有关。不幸的是，分娩后吸毒再次增加。随着孕酮水平的升高，妊娠期间药物使用的逐渐减少，分娩后孕酮水平下降时药物使用的增加，提示孕酮可能影响药物使用。这项申请寻求资金，以获得孕酮治疗是否能减少产后妇女可卡因使用的初步数据，孕酮治疗可以抵消分娩时失去的孕酮。因此，我们建议进行一项双盲、随机、安慰剂对照试验，以获得口服微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。我们将随机选取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。参与者还将接受有关吸毒的认知行为咨询。结果测量包括试验期间随机分配到两种情况（安慰剂或黄体酮）中的一种或另一种的妇女使用可卡因的天数百分比和数量。

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.