A Novel Approach to Reduce Pain, Prescription Opioid Use & Misuse in Pregnancy

 描述（由申请人提供）：处方阿片类药物（PO）被开给大量的孕妇：14-21%的生活在美国的妇女在怀孕期间接受这些药物。我们的初步数据进一步表明，在整个怀孕期间，使用和滥用这些药物的妇女人数高得惊人。考虑到与PO误用相关的母体风险（例如，PO滥用、意外过量、死亡）以及与宫内PO暴露相关的胎儿风险（例如，胎儿畸形、低出生体重、早产、新生儿禁欲综合征）。尽管妊娠期PO暴露的悲剧性后果和昂贵的影响，但没有基于证据的非药物干预措施可用于减少妊娠期疼痛、PO使用和误用。候选人将通过以下培训和研究活动填补这一关键空白，并解决这一未满足的临床需求。拟议的辅导病人为导向的职业发展奖（K23）是专门为提供国家的科学成瘾研究培训，并在成瘾研究的实践经验和指导（主要导师：Kathleen布雷迪，医学博士，博士），怀孕成瘾（Hendree Jones，PhD）治疗开发和评估（Sudie Back，博士），疼痛管理（Jeffery Borckardt，博士; John奥蒂斯，博士）和产科研究（Roger纽曼，医学博士）。候选人的长期培训目标是实现作为一个以病人为导向的成瘾研究独立。候选人的长期研究目标是为孕妇制定以成瘾为重点的干预措施。本申请的研究目标是：1）开发一种行为干预措施，以减少妊娠期间的疼痛、PO使用和误用; 2）评估干预措施的可行性和初步效果。中心假设是，使用PO的孕妇愿意参加认知行为治疗（CBT），以减少疼痛，PO的使用和滥用在怀孕期间，那些接受CBT将有更少的疼痛，PO的使用和滥用。在初步数据的指导下，这些假设将通过追求两个具体目标进行测试：1）在使用PO药物的孕妇中进行慢性疼痛CBT的开放标签试点研究，并获得将指导CBT计划修改的关键信息人反馈; 2）开展一项初步随机对照试验，以评估改良CBT方案的可行性和初步效果，与注意力控制条件相比，妇女健康教育（WHE）在减少疼痛，功能障碍和PO使用和滥用怀孕期间。拟议的研究将导致对妊娠期间PO使用管理知识的重大进步。这项研究的贡献是显著的，因为它有可能通过以下方式改善妇女及其子女的生活：1）改善产妇疼痛和功能; 2）减少妊娠期间阿片类药物暴露和相关不良后果; 3）预防与PO使用相关的长期风险，包括阿片类药物误用，滥用，过量和死亡。

 DESCRIPTION (provided by applicant): Prescription opioids (PO) are prescribed to an astonishingly high number of pregnant women: 14-21% of women living in the U.S. receive these medications during pregnancy. Our preliminary data further demonstrate that an alarmingly high number of women use and misuse these medications throughout pregnancy. The overall benefit of these medications is questionable when considering the maternal risks associated with PO misuse (e.g., PO abuse, unintentional overdose, death) as well as fetal risks associated with in-utero PO exposure (e.g., fetal malformations, low birth weight, prematurity, neonatal abstinence syndrome). Despite the tragic consequences and costly effects of PO exposure in pregnancy, no evidence- based non-pharmacological interventions are available to reduce pain, PO use and misuse in pregnancy. The candidate will fill this critical gap and address this unmet clinical need by pursing the following training and research activities. The proposed Mentored Patient-Oriented Career Development Award (K23) is specifically designed to provide state-of-the science addictions research training, and hands-on-experience and mentorship in addictions research (Primary Mentor: Kathleen Brady, MD, PhD), addictions in pregnancy (Hendree Jones, PhD) treatment development and evaluation (Sudie Back, PhD), pain management (Jeffery Borckardt, PhD; John Otis, PhD) and obstetrics research (Roger Newman, MD). The candidate's long-term training goal is to achieve independence as a patient-oriented addictions researcher. The candidate's long- term research goal is to develop addictions-focused interventions for pregnant women. The research objectives of the current application are to: 1) Develop a behavioral intervention to reduce pain, PO use and misuse during pregnancy; and 2) Evaluate the feasibility and preliminary effects of the intervention. The central hypotheses are that pregnant women using POs will be willing to take part in Cognitive Behavioral Therapy (CBT) for the reduction of pain, PO use and misuse in pregnancy and, those receiving CBT will have less pain, PO use and misuse. Guided by preliminary data, these hypotheses will be tested by pursuing two-specific aims: 1) Conduct an open label pilot study of CBT for Chronic Pain, in pregnant women using PO medications and obtain key-informant feedback that will guide modifications of the CBT program; and 2) Conduct a pilot randomized controlled trial to evaluate the feasibility and preliminary effects of the modified CBT program, compared to an attention control condition, Women's Health Education (WHE), in reducing pain, functional impairment and PO use and misuse during pregnancy. The proposed research will result in a critical advance in knowledge about the management of PO use during pregnancy. The contribution of this research is significant because it has the potential to improve the lives f women and their children by: 1) improving maternal pain and functioning; 2) decreasing opioid exposure in pregnancy and associated adverse outcomes; and 3) preventing long-term risks associated with PO use including opioid misuse, abuse, overdose and death.