Adaptation and Refinement of a Clinically Applicable Phenotypic Battery to Individualize Opioid Use Disorder Treatment for Women Through the Postpartum Period

临床适用的表型组合的调整和完善，用于对产后妇女进行阿片类药物使用障碍的个体化治疗

• 批准号: 10191241
• 负责人: Caitlin Eileen Martin
• 金额: $ 20.53万
• 依托单位: VIRGINIA COMMONWEALTH UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-01 至 2026-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10191241
• 关键词: Abstinence; Address; Aftercare; Alcohols; Anxiety; Area; Behavior Therapy; Biological; Birth; Buprenorphine; Cause of Death; Child; Child Custody; Clinical; Clinical Trials; Cohort Studies; Collaborations; Data; Data Reporting; Development; Dose; Effectiveness; Emotional; Environment; Ethics; Event; Face; Funding; Future; Goals; Gynecologist; Healthcare; Impairment; Impulsivity; Individual; Infant Health; Institutes; Insurance; Interview; K-Series Research Career Programs; Knowledge; Measures; Medicine; Mental Depression; Mentorship; Methods; Moods; National Institute of Drug Abuse; Neonatal; Neurobiology; Opioid; Outcome; Overdose; Patients; Pattern; Perinatal; Periodicity; Pharmaceutical Preparations; Phenotype; Physicians; Pilot Projects; Population; Postpartum Period; Postpartum Women; Pregnancy; Prenatal care; Provider; Psychosocial Factor; Qualitative Methods; Quality of Care; Quality of life; Recovery; Regimen; Reporting; Research; Research Personnel; Research Training; Resources; Science; Scientist; Services; Social Work; Statistical Data Interpretation; Stress; Structure; Testing; Therapeutic; Time; Training; Treatment Protocols; Treatment outcome; Withdrawal; Woman; Work; addiction; alcohol use disorder; antidepressant effect; behavioral health; biopsychosocial; biopsychosocial factor; career; clinical application; clinical care; evidence base; fourth trimester; improved; improved outcome; individualized medicine; innovation; insight; interest; medical specialties; neurobehavioral; novel strategies; opioid mortality; opioid overdose; opioid use disorder; overdose risk; perinatal period; personalized approach; personalized medicine; pregnancy associated death; prenatal; prescription opioid; programs; promoter; prospective; psychologic; psychosocial; routine care; skills; social; stressor; substance use; targeted treatment; treatment optimization; treatment response

PROJECT SUMMARY Opioid overdose is a leading cause of pregnancy-associated mortality with most of these events occurring through the 12 months after delivery rather than the 9 months before delivery. Historically, the bulk of research on opioid use disorder (OUD) in this population has focused on pregnancy rather than postpartum. The ‘Fourth Trimester’ carries significant unique stressors, and women with OUD are especially vulnerable given the addi- tional stressors they face specific to addiction. Comprehensive treatment during pregnancy includes medica- tion for OUD (MOUD) with wrap-around services such as behavioral health and prenatal care. However, post- partum OUD treatment continuation rates are poor, opioid-related deaths increase, and even for women on MOUD within the month of delivery, postpartum overdose risk is not diminished. We urgently need evidence to guide how to improve not only postpartum OUD treatment continuation but also its effectiveness at strengthen- ing recovery, operationalized as abstinence or decreased substance use with improved quality of life. A novel approach to address this critical knowledge gap is to assess a woman’s multidimensional profile (‘phenotype’) at the pregnancy to postpartum transition then use that information to tailor her treatment regimen (e.g., dosing of buprenorphine, addition of other medications, targeted behavioral therapies) going forward after delivery. Multidimensional (‘phenotypic’) variables that determine one’s profile include biological, neurobehavioral and psychosocial factors. This strategy is in line with our current understanding of addiction having a neurobiologi- cal basis modified by one’s psychosocial context that can vary over the lifecourse. The proposed research has three aims: (1) Obtain qualitative data from women on MOUD and providers in perinatal addiction on chal- lenges and promoters of recovery specific to the postpartum period, (2) Use this data to systematically revise a battery developed by NIDA in collaboration with the VCU Institute for Drug and Alcohol Studies to tailor it for women in the postpartum transition and to be feasible in a busy clinical environment, (3) Assess correlations between multidimensional variables, treatment and recovery outcomes through 12 months after delivery. The data from this innovative study will inform a clinical trial of an individualized treatment regimen for postpartum women on MOUD. This project focuses on two high priority areas to NIDA –personalization of addiction treat- ments and OUD through the perinatal period. The PI, Dr. Martin, is an Early-Career Investigator, obstetrician- gynecologist and addiction medicine physician. This career development award will fill gaps in her training nec- essary for her transition to independence in addictions research (in line with Notice of Special Interest NOT- DA-20-037). Specifically, Dr. Martin will advance her knowledge and skills in clinical trials, mixed methods re- search, addiction therapeutics, neurobehavioral science, advanced statistical analyses, professional develop- ment as well as the responsible and ethical conduct of research. She will work closely with a mentorship team and consultants with expertise across these specialties to carry out her career objectives and research aims.

项目概要 阿片类药物过量是妊娠相关死亡的主要原因，其中大多数事件都会发生 分娩后 12 个月，而不是分娩前 9 个月。从历史上看，大部分研究 对这一人群中阿片类药物使用障碍（OUD）的关注重点是妊娠期而非产后。 ‘第四个 三个月期带有显着的独特压力源，患有 OUD 的女性尤其容易受到伤害，因为 他们面临的特定于成瘾的心理压力源。怀孕期间的综合治疗包括药物治疗 为 OUD (MOUD) 提供全方位服务，例如行为健康和产前护理。然而，后 产妇 OUD 治疗持续率很低，与阿片类药物相关的死亡人数增加，甚至对于接受阿片类药物治疗的妇女来说也是如此。 MOUD在分娩当月内，产后服用过量的风险并未减少。我们迫切需要证据 指导如何不仅改善产后 OUD 治疗的持续性，而且改善其在强化方面的有效性 康复，具体表现为戒酒或减少药物使用，提高生活质量。一本小说 解决这一关键知识差距的方法是评估女性的多维概况（“表型”） 在怀孕到产后过渡期间，然后使用该信息来定制她的治疗方案（例如，剂量 丁丙诺啡、添加其他药物、有针对性的行为疗法）在分娩后继续进行。 决定一个人特征的多维（“表型”）变量包括生物、神经行为和 心理社会因素。这一策略符合我们目前对具有神经生物学特征的成瘾的理解。 一个人的心理社会背景会改变其基础，而心理社会背景在整个生命过程中可能会发生变化。拟议的研究有 三个目标：(1) 从 MOUD 妇女和围产期成瘾提供者那里获得关于 Chal- 的定性数据。 产后恢复的具体过程和促进因素，(2) 使用这些数据系统地修正 NIDA 与 VCU 药物和酒精研究所合作开发的电池，专门针对 处于产后过渡期的女性，并在繁忙的临床环境中可行，(3) 评估相关性 产后 12 个月内的多维变量、治疗和恢复结果之间的关系。这 这项创新研究的数据将为产后个体化治疗方案的临床试验提供信息 MOUD 上的女性。该项目重点关注 NIDA 的两个高度优先领域——成瘾治疗的个性化—— 整个围产期的精神状况和 OUD。 PI，Martin 博士，是一名早期职业研究员、产科医生 妇科医生和成瘾医学医师。该职业发展奖将填补她在培训方面的空白 她在成瘾研究中向独立过渡的essary（根据特殊兴趣通知不- DA-20-037）。具体来说，马丁博士将提高她在临床试验、混合方法重新开发方面的知识和技能。 搜索、成瘾治疗、神经行为科学、高级统计分析、专业发展 以及负责任和道德的研究行为。她将与导师团队密切合作 以及具有这些专业知识的顾问，以实现她的职业目标和研究目标。