Buprenorphine Assignment in Pregnancy: Objective Criteria

 描述（由申请人提供）：伊丽莎白博士。克兰斯是匹兹堡大学妇产科和生殖科学助理教授。她的长期职业目标是成为一名独立的研究人员，专注于优化妊娠期间药物治疗的有效性，以改善孕产妇和新生儿的结局。这个为期三年的K23奖项的目标是为克兰斯博士提供必要的指导，时间和支持，以实现以下培训目标：a）对成瘾医学和药物治疗过程有批判性的、实质性的理解，B）发展必要的方法技能，以评价和比较对患有药物使用障碍的孕妇的治疗干预措施，以及培养成为独立调查员所需的科学管理和领导实践技能。美沙酮和丁丙诺啡是两种临床上适用于怀孕的治疗方法。然而，我们不知道哪种治疗（美沙酮与丁丙诺啡）对怀孕期间的特定患者最有效。在临床环境中，美沙酮和丁丙诺啡治疗方案的结构、程序和辅助服务截然不同，这些差异对孕产妇结局的影响尚未得到评估。为了实现这一目标，Krans博士将进行一项试点随机临床试验，比较基于办公室的丁丙诺啡与联邦政府许可的美沙酮计划，用于治疗阿片类药物依赖的孕妇。主要研究目的是：1）评估进行随机研究的可行性，比较基于办公室的丁丙诺啡与联邦许可的美沙酮计划; 2）描述孕妇及其提供者对丁丙诺啡与美沙酮治疗妊娠期间阿片类药物依赖的观点; 3）评估评价产后期治疗结果的可行性，并确定与减少妊娠期非法药物使用相关的关键产后功能结果。这项研究将确定对这一高风险、高度流动的人群进行研究所面临的具体挑战， 并审查结果措施，评估工具和参与者跟踪技术，以解决与招募和登记不良，提前终止和跟踪和随访困难有关的问题。该项目的研究结果将提供初步数据，以支持R 01关于比较有效性临床试验的建议，该临床试验旨在比较基于办公室的丁丙诺啡与联邦政府许可的美沙酮计划，用于治疗妊娠期间的阿片类药物依赖。这一系列研究的最终目标是制定临床指南，指导提供者就阿片类药物依赖孕妇的最有效治疗（丁丙诺啡与美沙酮）做出决策。

 DESCRIPTION (provided by applicant): Dr. Elizabeth E. Krans is an Assistant Professor of Obstetrics, Gynecology and Reproductive Sciences at the University of Pittsburgh. Her long-term career goal is to become an independent investigator focused on optimizing the effectiveness of drug treatment during pregnancy to improve maternal and neonatal outcomes. The goal of this three-year K23 award is to provide Dr. Krans with the mentorship, time and support necessary to achieve the following training goals: a) develop a critical, substantive understanding of addiction medicine and the drug treatment process, b) develop the methodological skills necessary to evaluate and compare treatment interventions for pregnant women with substance use disorders and c) develop the practical skills in scientific management and leadership necessary to become an independent investigator. Methadone and buprenorphine are two clinically appropriate treatments in pregnancy. However, we do not know which treatment (methadone vs. buprenorphine) is most effective for a particular patient during pregnancy. In clinical settings, methadone and buprenorphine treatment programs have starkly different structures, procedures and ancillary services and the impact of these differences on maternal outcomes has not been evaluated. To achieve this goal, Dr. Krans will conduct a pilot randomized clinical trial comparing office-based buprenorphine vs. federally licensed methadone programs for the treatment of opioid dependent pregnant women. The primary research aims are to 1) evaluate the feasibility of conducting a randomized study comparing office-based buprenorphine vs. federally licensed methadone programs; 2) describe the perspectives of pregnant women and their providers regarding buprenorphine vs. methadone for the treatment of opioid dependence during pregnancy; 3) assess the feasibility of evaluating treatment outcomes in the postpartum period and identify key postpartum functional outcomes relevant to reductions in illicit drug use during pregnancy. This study will identify the challenge specific to conducting research with this high-risk, highly transient population as well as develop and vet the outcome measures, assessment tools and participant tracking techniques needed to address problems related to poor recruitment and enrollment, early termination and difficulty with tracking and follow-up. Findings from this project will provide the preliminary data to suppor a R01 proposal for a comparative effectiveness clinical trial designed to compare office-based buprenorphine vs. federally licensed methadone programs for the treatment of opioid dependence during pregnancy. The ultimate goal of this line of research is develop clinical guidelines that can guide provider decision-making regarding the most effective treatment (buprenorphine vs. methadone) for opioid dependent pregnant women.