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: 10381663
• 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/10381663
• 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; Overdose reduction; 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; Recovery Support; 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; 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.

项目摘要 阿片类药物过量是与怀孕相关死亡率的主要原因，其中大多数发生 在交货后的12个月内，而不是交货前的9个月。从历史上看，大部分研究 关于阿片类药物使用障碍（OUD），该人群的重点是怀孕而不是产后。第四 妊娠中期有巨大的独特压力，鉴于ADDI- 他们面临着特定于成瘾的压力。怀孕期间的全面治疗包括医疗 OUD（MOUD）具有环绕式服务，例如行为健康和产前护理。但是， Partum Oud治疗延续率很差，阿片类药物相关的死亡人数增加，甚至对于女性 穆德在分娩的月份内，产后过量风险不会减少。我们迫切需要证据 指导如何不仅改善产后治疗延续，还可以改善其在强度方面的有效性 - 恢复，以禁欲或改善的物质使用，并改善了生活质量。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，然后使用该信息来调整治疗方案（例如，给药 分娩后，丁丙诺啡，其他药物的添加，针对性的行为疗法）。 确定一个人的概况的多维（“表型”）变量包括生物学，神经行为和 社会心理因素。该策略符合我们目前对增加神经生物学的理解 通过一个人的社会心理环境来修改的基础，这些环境可能会随着生命的方式而变化。拟议的研究已经 三个目的：（1）从穆德（Moud）的女性和围产期成瘾的妇女获得定性数据。 特定于产后时期的恢复的长度和启动子，（2）使用此数据系统修订 NIDA与VCU毒品和酒精研究所合作开发的电池，以量身定制 产后过渡中的妇女，在繁忙的临床环境中可行，（3）评估相关性 在分娩后12个月内，多维变量，治疗和恢复结果之间。这 这项创新研究的数据将为产后的个性化治疗方案提供临床试验 穆德的女人。该项目侧重于NIDA的两个高优先级 - 成瘾治疗的人格化 - 在围产期期间和OUD。 PI Martin博士是一名早期研究员，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的培训NEC的空白 - 当她过渡到成瘾研究中的独立性（与特殊兴趣的通知一致） DA-20-037）。特别是，马丁博士将提高她在临床试验中的知识和技能，混合方法重新培养 搜索，成瘾疗法，神经行为科学，高级统计分析，专业发展 - 男性以及负责任的研究行为。她将与Mentalship团队紧密合作 以及在这些专业中具有专业知识的顾问，以实现她的职业目标和研究目标。