Prevention of Methamphetamine Use among Postpartum Women (PROMPT)

预防产后妇女使用甲基苯丙胺 (PROMPT)

• 批准号: 10194890
• 负责人: Marcela Smid
• 金额: $ 30.5万
• 依托单位: UNIVERSITY OF UTAH
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-06-15 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10194890
• 关键词: Abstinence; Address; Affect; Allopregnanolone; Attention; Attenuated; Benzodiazepines; Biological; Caring; Cessation of life; Child; Clinic; Cocaine; Colorado; Control Groups; Data; Dependence; Disease; Disease remission; Drops; Drug usage; Enrollment; Epidemic; Frequencies; Goals; Health; Hormonal; Hormonal Change; Idaho; Intervention; Knowledge; Late pregnancy; Longevity; Mediating; Methamphetamine; Montana; Morbidity - disease rate; Mothers; Multi-Institutional Clinical Trial; National Institute of Drug Abuse; Nevada; Opioid; Oral; Outcome; Perinatal mortality demographics; Pharmaceutical Preparations; Pharmacology; Physiology; Placebos; Population; Postpartum Period; Postpartum Women; Pregnancy; Pregnant Women; Prevention; Progesterone; Public Health; Questionnaires; Randomized; Recovery; Research; Resources; Review Committee; Risk; Safety; Salivary; Scientific Advances and Accomplishments; Supplementation; Testing; Time; Tobacco; Tobacco use; Twin Multiple Birth; United States; Universities; Utah; Vulnerable Populations; Woman; Wyoming; addiction; adverse outcome; cocaine abuse in pregnancy; cocaine use; craving; drug craving; effective intervention; feasibility testing; improved; innovation; maternal methamphetamine use; methamphetamine use; mortality; novel; novel therapeutics; opioid epidemic; opioid use; opioid use disorder; polysubstance use; pregnant; prenatal; prescription opioid; prevent; randomized placebo controlled trial; research study; substance use; treatment group

PROJECT SUMMARY In the midst of the opioid epidemic, the methamphetamine epidemic has devastated the Western United States, These twin epidemics have profoundly affected pregnant and postpartum women. Indeed, the majority of women receiving care at the University of Utah's Substance Use and Pregnancy – Recovery, Addiction, Dependence clinic have methamphetamine use disorder (MUD). Methamphetamine use (MU) frequently decreases during pregnancy. The hormonal changes of pregnancy, specifically the increased levels of progesterone and its metabolite allopregnanolone, may decrease craving and drug use among pregnant women. Conversely, the precipitous postpartum hormonal drop may increase the risk of return to use. Studies of progesterone supplementation in the postpartum period have shown promising results in reducing return to cocaine and tobacco use among postpartum women. Our long-term goal is to advance the understanding of how pregnant and postpartum women's unique physiology impacts the trajectory of MUD and to apply this knowledge to developing novel interventions aimed at reducing MU in this population. The objective of this R21 application is to test the feasibility, safety and preliminary efficacy of progesterone supplementation to reduce return to MU among postpartum women and to explore the association between allopregnanolone levels and methamphetamine craving. The rationale for this project is that progesterone will reduce return to MU among postpartum women. This research study will pursue two specific aims: (1) To assess feasibility, safety, and preliminary efficacy of micronized progesterone to decrease return to MU among postpartum women with MUD; (2) To evaluate the association between salivary allopregnanolone levels and methamphetamine craving in control and treatment groups. For Aim 1, we will randomize postpartum women with MUD who have achieved abstinence for at least one month prior to delivery to micronized progesterone, which metabolizes into allopregnanolone, or placebo and will assess MU over 12 weeks. We will track enrollment and retention of women with MUD, safety of this intervention and establish preliminary efficacy of progesterone to reduce return to MU. For Aim 2, we will test the hypothesis that increased allopregnanolone levels are correlated with reduced methamphetamine cravings among postpartum women. This project is innovative as it addresses a significant health issue facing this vulnerable population with a novel intervention. The proposed research is significant because of its potential to improve public health by decreasing MU among postpartum women and to advance scientific knowledge by investigating the association between allopregnanolone and methamphetamine cravings.

项目总结 在阿片类药物流行的过程中，甲基苯丙胺流行已经摧毁了美国西部， 这两种流行病深刻地影响了孕妇和产后妇女。事实上，大多数女性 在犹他大学接受治疗的药物使用和怀孕--康复、上瘾、依赖 临床上有甲基苯丙胺使用障碍(MUD)。甲基苯丙胺使用量(MU)在 怀孕了。妊娠激素的变化，特别是孕酮及其受体水平的升高。 代谢物别孕酮，可能会减少孕妇的渴求和药物使用。反之， 产后荷尔蒙急剧下降可能会增加重新使用的风险。孕酮的研究进展 产后补充剂在减少可卡因的回升和 产后妇女的烟草使用情况。我们的长期目标是促进对怀孕方式的理解 产后妇女独特的生理影响泥浆的运动轨迹，并将这一知识应用于 开发新的干预措施，旨在减少这一人群的MU。此R21应用程序的目标是 试验补充孕酮减少小鼠复发率的可行性、安全性和初步疗效 对产后妇女的影响，并探讨别孕酮水平与 对冰毒的渴望。这个项目的基本原理是，黄体酮将减少MU的返回率 产后妇女。本研究将追求两个具体目标：(1)评估可行性、安全性和 目的探讨微粒化黄体酮治疗产后MU的临床疗效。 (2)评价唾液别孕酮水平与儿童对甲基苯丙胺渴求的关系。 对照组和治疗组。对于目标1，我们将随机选择患有MUD的产后妇女 在服用微粒化黄体酮之前至少禁欲一个月，黄体酮将代谢成 别孕酮，或安慰剂，将在12周内评估MU。我们将跟踪注册和保留 对患有泥浆的妇女，这种干预的安全性并初步确立了黄体酮减少复发的疗效 致密歇根大学。对于目标2，我们将检验这样的假设，即增加的别孕酮水平与减少的 产后妇女对甲基苯丙胺的渴望。这个项目是创新的，因为它解决了一个重要的 通过一种新的干预措施解决这一弱势群体面临的健康问题。这项拟议的研究具有重要意义 因为它有可能通过降低产后妇女的MU来改善公共健康，并促进 通过调查别孕酮和甲基苯丙胺渴求之间的联系，获得科学知识。