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: 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
• 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

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.

项目摘要 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孕酮或安慰剂的试验。这 研究的目的有两个：（1）评估药物的可行性、安全性和初步疗效， 微粉化孕酮，以减少产后个体中甲基苯丙胺的使用 甲基苯丙胺使用障碍;（2）评估唾液别孕烯醇酮水平与 控制组和治疗组对甲基苯丙胺的渴望。对于目标1，我们随机选择40名产后 在妊娠结束后12周内患有甲基苯丙胺使用障碍的人， 戒断四周的微粉化孕酮或安慰剂，并将评估甲基苯丙胺的使用超过 12周我们正在跟踪产后个体的登记和保留情况，这种干预措施的安全性， 确定孕酮减少甲基苯丙胺复吸的初步疗效。目标2： 测试增加的别孕烯醇酮水平，微粉化孕酮的活性代谢物， 与产后个体对甲基苯丙胺的渴望减少有关。我们的长期目标是 促进对产后个体独特生理学如何影响甲基苯丙胺使用的理解 并将这些知识应用于开发旨在减少甲基苯丙胺使用的新干预措施 在这个人群中。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。 一个新的干预人群。这项研究具有重要意义，因为它有可能改善 通过减少产后妇女使用甲基苯丙胺， 通过调查别孕烯醇酮和甲基苯丙胺的渴望之间的关联知识。的 对父母补助金进行补充的理由是解决主要研究者的合格生活事件 这延迟了PROMPT研究的启动。补充资金将用于资助研究 协调员继续招募、入组和保留PROMPT研究受试者的时间。