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

项目总结 阿片类药物过量是妊娠相关死亡的主要原因，这些事件大多发生 在分娩后12个月，而不是分娩前的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)，这一人群的重点是怀孕，而不是产后。‘第四人’ 怀孕三个月会带来显著的独特压力，而患有先天性巨结肠的女性尤其容易受到这种压力的影响。 他们面临的特定于成瘾的压力因素。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全方位服务。然而，后- 产后继续治疗的比率很低，阿片类药物相关的死亡人数增加，甚至对服用阿片类药物的妇女来说也是如此 在分娩的一个月内，产后过量用药的风险并不减少。我们迫切需要证据来 指导如何提高产后继续治疗的质量，加强产后护理的有效性。 ING康复，以戒除或减少物质使用的方式运作，改善生活质量。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特征(‘表型’) 在怀孕到产后过渡时，然后使用该信息来定制她的治疗方案(例如，剂量 丁丙诺啡、其他药物的补充、靶向行为疗法)在分娩后继续进行。 决定一个人形象的多维(‘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成瘾的神经生物学理解-- CAL基础由一个人的心理社会背景修正，在生命过程中可能会有所不同。拟议中的研究已经 三个目标：(1)从Moud上的妇女和围产期吸毒成瘾的提供者那里获得定性数据。 产后恢复的时间和促进剂，(2)使用这些数据系统地修订 NIDA与VCU药物和酒精研究所合作开发的电池 产后过渡期的妇女和在繁忙的临床环境中可行的妇女，(3)评估相关性 在分娩后12个月期间的多维变量、治疗和恢复结果之间的关系。这个 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参考 Moud上的女人。该项目专注于NIDA的两个高度优先领域--成瘾治疗的个性化-- 在整个围产期分娩和分娩。私家侦探马丁博士是一名早期的调查员，产科医生- 妇科医生和成瘾药物医师。这一职业发展奖将填补她在NEC培训方面的空白- 她在成瘾研究方面过渡到独立的必备要素(符合特殊利益通知，不- DA-20-037)。具体地说，马丁博士将在临床试验中提高她的知识和技能，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- 以及负责任和合乎道德的研究行为。她将与一个指导团队密切合作 以及拥有这些专业知识的顾问，以实现她的职业目标和研究目标。

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.