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)被开给数量惊人的孕妇：居住在美国的妇女中有14%-21%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数量惊人地高。考虑到与PO滥用相关的母亲风险(例如，PO滥用、无意过量用药、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、新生儿禁欲综合症)，这些药物的整体益处是值得怀疑的。尽管孕期接触PO会带来悲惨的后果和昂贵的影响，但目前还没有基于证据的非药物干预措施来减少怀孕期间的疼痛、PO的使用和误用。候选人将通过追求以下培训和研究活动来填补这一关键空白，并解决这一未得到满足的临床需求。建议设立的以病人为导向的导师职业发展奖(K23)专门用于提供最新的科学成瘾研究培训、实践经验和指导，涉及成瘾研究(主要导师：凯瑟琳·布雷迪，医学博士)、孕期成瘾(亨德里·琼斯博士)、治疗发展和评估(苏迪·贝克博士)、疼痛管理(杰弗里·博克哈特博士；约翰·奥蒂斯，博士)和产科研究(罗杰·纽曼博士)。候选人的长期培训目标是作为一名以患者为导向的成瘾研究人员实现独立。这位候选人的长期研究目标是为孕妇开发针对成瘾的干预措施。目前应用的研究目标是：1)开发一种行为干预，以减少怀孕期间疼痛、PO的使用和滥用；2)评估干预的可行性和初步效果。中心假设是，使用POS的孕妇将愿意参加认知行为疗法(CBT)，以减少怀孕期间的疼痛、PO的使用和滥用，而接受认知行为疗法的孕妇将减少疼痛、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特定目标来检验：1)在使用PO药物的孕妇中进行一项CBT治疗慢性疼痛的开放式标签试点研究，并获得将指导修改CBT计划的关键信息者反馈；以及2)进行一项试点随机对照试验，以评估修改后的CBT计划与注意力控制条件--妇女健康教育(WHE)--在减少妊娠期间疼痛、功能障碍以及PO的使用和滥用方面的可行性和初步效果。这项拟议的研究将在孕期使用PO的管理方面的知识方面取得重大进展。这项研究的贡献是重大的，因为它有可能通过以下方式改善妇女及其子女的生活：1)改善产妇的痛苦和功能；2)减少怀孕期间阿片类药物的暴露和相关的不良后果；3)防止与PO使用有关的长期风险，包括阿片类药物滥用、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.