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: 10428613
• 负责人: Marcela Smid
• 金额: $ 11.44万
• 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 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10428613
• 关键词: Abstinence; Address; Affect; Allopregnanolone; Attention; Attenuated; Benzodiazepines; Biological; Caring; Cessation of life; Child; Clinic; Cocaine; Colorado; Control Groups; Data; Dependence; Disease remission; Drops; Drug usage; Enrollment; Epidemic; Frequencies; Goals; Health; Hormonal; Hormonal Change; Idaho; Intervention; Knowledge; Late pregnancy; Longevity; Mediating; Methamphetamine; Methamphetamine prevention; Methamphetamine use disorder; 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; Progesterone; Public Health; Questionnaires; Randomized; Recovery; Research; Resources; Review Committee; Risk; Safety; Salivary; Scientific Advances and Accomplishments; Stimulant; Supplementation; Testing; Time; Tobacco; Tobacco use; Twin Multiple Birth; United States; Universities; Utah; Vulnerable Populations; Woman; Wyoming; addiction; adverse outcome; cocaine use; cocaine use in pregnancy; 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; 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.

项目摘要 在OOid流行中，甲基苯丙胺的流行摧毁了美国西部， 这些双胞胎流行病严重影响了孕妇和产后妇女。确实，大多数妇女 在犹他大学的物质使用和怀孕接受护理 - 恢复，成瘾，依赖 诊所患有甲基苯丙胺使用障碍（MUD）。甲基苯丙胺的使用（MU）经常在 怀孕。怀孕的激素变化，特别是孕酮及其水平升高 代谢产物异烷醇酮可能会减少孕妇的渴望和吸毒。相反， 急剧的产后荷尔蒙下降可能会增加使用回报的风险。孕酮研究 产后时期的补充已显示出有望导致减少可卡因的返回和 产后妇女中使用烟草。我们的长期目标是促进对怀孕的理解 产后妇女的独特生理学会影响泥浆的轨迹，并将这些知识应用于 开发旨在减少该人群中MU的新型干预措施。该R21应用程序的目的是 测试补充孕激素的可行性，安全性和初步效率以减少对MU的回报 在产后妇女中，并探讨异源酮水平和 甲基苯丙胺的渴望。该项目的理由是，孕酮将减少回报率 产后妇女。这项研究将追求两个具体目标：（1）评估可行性，安全性和 在产后泥浆中降低微元素孕酮的初步效果，以减少泥浆的恢复； （2）评估唾液异烷酮水平与甲基苯丙胺渴望之间的关联 控制和治疗组。对于AIM 1，我们将随机将实现的泥浆产后妇女 在交付至微粉化孕酮之前至少禁止戒酒，该孕酮代谢 Allopregnanolone或安慰剂，将在12周内评估MU。我们将跟踪注册和保留 有泥浆的妇女，这种干预的安全和孕酮的初步效率以减少回报 去穆。对于AIM 2，我们将测试以下假设：增加的异烷酮水平与降低相关 产后妇女中的甲基苯丙胺渴望。该项目具有创新性，因为它解决了重要的 通过新的干预措施面临着脆弱人群面临的健康问题。拟议的研究很重要 因为它有潜力通过减少产后妇女中的MU来改善公共卫生并促进 通过研究Allopregnanolone和甲基苯丙胺渴望之间的关联，科学知识。