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 阿片类药物过量是妊娠相关死亡的主要原因，其中大多数事件发生在 在分娩后的12个月内，而不是分娩前的9个月。从历史上看， 阿片类药物使用障碍（OUD）在这一人群中的重点是怀孕，而不是产后。'第四 三个月的“携带显着的独特的压力源，和妇女与OUD是特别脆弱的，考虑到额外的， 他们面对的特定于成瘾的心理压力。妊娠期综合治疗包括药物治疗， 提供行为健康和产前护理等综合服务。然而，后- 分娩OUD治疗继续率很低，阿片类药物相关死亡增加，甚至对于 MOUD在分娩的一个月内，产后用药过量的风险并不减少。我们急需证据 指导如何不仅提高产后OUD治疗的持续性，而且提高其在加强- 恢复期，可操作为禁欲或减少物质使用，改善生活质量。一种新型 解决这一关键知识差距的方法是评估妇女的多方面情况（“表型”） 然后使用该信息来定制她的治疗方案（例如，给药 丁丙诺啡，添加其他药物，有针对性的行为治疗）。 决定个人特征的多维（“表型”）变量包括生物学、神经行为和 心理社会因素这一策略符合我们目前对成瘾的理解， 由一个人的心理社会背景改变的基础，可以在整个生命过程中变化。拟议的研究已 三个目标：（1）从妇女和提供者那里获得关于MOUD的定性数据， 产后恢复的促进者，（2）使用这些数据系统地修改 NIDA与VCU药物和酒精研究所合作开发的电池， 妇女在产后过渡期和在忙碌的临床环境中是可行的，（3）评估相关性 多维变量，治疗和恢复结果之间的关系，直到分娩后12个月。的 这项创新研究的数据将为产后的个性化治疗方案的临床试验提供信息。 MOUD上的女人该项目侧重于NIDA的两个高优先级领域-成瘾治疗的个性化- 和OUD通过围产期。私家侦探马丁博士是一名早期职业调查员，产科医生- 妇科医生和成瘾医学医生。这个职业发展奖将填补她的培训nec- 她在成瘾研究中向独立过渡的必要条件（符合特别关注的通知， DA-20-037）。马丁将推进她的知识和技能，在临床试验，混合方法重新- 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。她将与一个导师团队密切合作， 和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。