Prevention of Methamphetamine Use among Postpartum Women (PROMPT)

预防产后妇女使用甲基苯丙胺 (PROMPT)

基本信息

批准号：
10631709
负责人：
Marcela Smid
金额：
$ 7.68万
依托单位：
UNIVERSITY OF UTAH
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-06-01 至 2024-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10631709
关键词：
Abstinence Address Affect Allopregnanolone Attention Attenuated Benzodiazepines Caring Cessation of life Clinic Cocaine Colorado Control Groups Data Dependence Disease remission Drops Enrollment Epidemic Event Family Funding Goals Health Hormonal Change Idaho Individual Intervention Knowledge Late pregnancy Life Mediating Methamphetamine Methamphetamine prevention Methamphetamine use disorder Montana Nevada Opioid Oral Outcome Parental Leave Parents Perinatal mortality demographics Pharmaceutical Preparations Pharmacology Physiology Placebos Population Postpartum Period Postpartum Women Pregnancy Pregnant Women Principal Investigator Productivity Progesterone Public Health Qualifying Questionnaires Randomized Randomized Controlled Trials Recovery Research Research Support Resources Review Committee Risk Safety Salivary Scientific Advances and Accomplishments Stimulant Supplementation Testing Time Tobacco Twin Multiple Birth United States National Institutes of Health Universities Utah Vulnerable Populations Wages Woman Wyoming addiction adverse outcome cocaine use cocaine use in pregnancy craving drug craving effective intervention improved innovation methamphetamine use novel novel therapeutics opioid epidemic opioid use opioid use disorder parent grant participant retention pregnant prenatal randomized placebo controlled trial recruit research study substance use treatment group

项目摘要

PROJECT SUMMARY PRevention Of Methamphetamine Use among Postpartum Women Trial (PROMPT) is a randomized controlled trial of postpartum individuals with methamphetamine use disorder to micronized progesterone or placebo. This research study is pursuing two specific aims: (1) To assess feasibility, safety, and preliminary efficacy of micronized progesterone to decrease return to methamphetamine use among postpartum individuals with methamphetamine use disorder; (2) To evaluate the association between salivary allopregnanolone levels and methamphetamine craving in control and treatment groups. For Aim 1, we are randomizing 40 postpartum individuals with methamphetamine use disorder within 12 weeks of the end of pregnancy who have achieved abstinence for four weeks to micronized progesterone or placebo and will assess methamphetamine use over 12 weeks. We are tracking enrollment and retention of postpartum individuals, safety of this intervention and establishing preliminary efficacy of progesterone to reduce return to methamphetamine use. For Aim 2, we are testing the hypothesis that increased allopregnanolone levels, an active metabolite of micronized progesterone, are correlated with reduced methamphetamine cravings among postpartum individuals. Our long-term goal is to advance the understanding of how postpartum individual’s unique physiology impacts methamphetamine use disorder and to apply this knowledge to developing novel interventions aimed at reducing methamphetamine use in this population. 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 methamphetamine use among postpartum women and to advance scientific knowledge by investigating the association between allopregnanolone and methamphetamine cravings. The rationale for this supplement to the parent grant is to address the Principal Investigator’s qualifying life event which delayed the start-up of PROMPT study. The supplement’s funding will be used to fund research coordinator time to continue recruitment, enrollment and retention of participants in the PROMPT study.

项目概要预防产后妇女使用甲基苯丙胺试验 (PROMPT) 是一项随机对照试验对患有甲基苯丙胺使用障碍的产后个体进行微粉化黄体酮或安慰剂的试验。研究性研究追求两个具体目标：（1）评估可行性、安全性和初步有效性微粉化黄体酮可减少产后患有甲基苯丙胺的人重新使用甲基苯丙胺甲基苯丙胺使用障碍；（2）评估唾液异孕酮水平与对于目标 1，我们将 40 名产后患者随机分组。怀孕结束后 12 周内患有甲基苯丙胺使用障碍且已达到戒断微粉化黄体酮或安慰剂四个星期，并将评估甲基苯丙胺的使用情况 12 周，我们正在跟踪产后个体的注册和保留情况、该干预措施的安全性以及确定黄体酮对减少甲基苯丙胺重新使用的初步功效。对于目标 2，我们正在研究。验证异孕酮水平升高的假设，异孕酮是微粉化黄体酮的活性代谢物，与产后个体对甲基苯丙胺的渴望减少相关，我们的长期目标是。促进对产后个体独特的生理机能如何影响甲基苯丙胺使用的理解并将这些知识应用于制定旨在减少甲基苯丙胺使用的新干预措施该项目具有创新性，因为它解决了这一弱势群体面临的重大健康问题。拟议的研究具有重要意义，因为它具有改善的潜力。通过减少产后妇女使用甲基苯丙胺并促进科学发展来促进公共卫生通过调查四氢孕酮和甲基苯丙胺渴望之间的关联来了解知识。对家长补助金进行补充的理由是为了解决首席研究员的合格生活事件这推迟了 PROMPT 研究的启动。该补充资金将用于资助研究。协调员继续招募、登记和保留 PROMPT 研究参与者的时间。