The Ohio Valley Node of the Clinical Trials Network

临床试验网络俄亥俄谷节点

• 批准号: 10441986
• 负责人: T John WINHUSEN
• 金额: $ 90.04万
• 依托单位: UNIVERSITY OF CINCINNATI
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-01 至 2022-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10441986
• 关键词: Abstinence; Age-Months; Biophysics; Breast Feeding; Buprenorphine; Caregivers; Child; Clinic; Clinical; Clinical Trials Network; Cognitive; Collection; Communities; Data; Databases; Drug Screening; Epidemic; Equilibrium; Formulation; Gestational Age; Health; Home visitation; Hospital Costs; Hospitals; Infant; Institution; Judgment; Laboratories; Location; Maintenance; Medical Records; Modeling; Mothers; Naloxone; National Institute of Drug Abuse; Neonatal Abstinence Syndrome; Ohio; Opioid; Outcome; Participant; Pharmaceutical Preparations; Phase; Plasma; Postpartum Period; Pregnancy; Pregnant Women; Prevalence; Procedures; Protocols documentation; Provider; Randomized; Randomized Controlled Trials; Research Design; Rest; Safety; Severities; Site; Telemedicine; Testing; Time; Toddler; Urine; Visit; Woman; arm; base; buprenorphine treatment; clinical research site; cost-effectiveness ratio; economic outcome; economic value; eligible participant; fetal; illicit opioid; improved; incremental cost-effectiveness; infant outcome; neurodevelopment; open label; opioid use; opioid use disorder; preference; primary outcome; randomized trial; recruit; secondary outcome; study population; trial comparing

NIDA CTN Protocol 0080 Medication treatment for Opioid use disorder in expectant Mothers (MOMs): a pragmatic randomized trial comparing extended-release and daily buprenorphine formulations 1.1 Study Objectives CTN?0080 includes four objectives: * Primary Objective: To evaluate the impact of treating opioid use disorder (OUD) in pregnant women with extended-release (XR) buprenorphine (BUP), compared to sublingual (SL) BUP, on mother and infant outcomes. Hypothesized outcomes are that the BUP-XR, relative to the BUP-SL, group will: 1) not have greater illicit opioid use during pregnancy (primary, non-inferiority); 2) have lower infant neonatal opioid withdrawal syndrome (NOWS) severity (key secondary, superiority); and 3) not have greater postpartum illicit opioid use (key secondary, non-inferiority). * Secondary Objective: To test conceptual models of the mechanisms by which BUP-XR may improve mother-infant outcomes, relative to BUP-SL. * Tertiary Objective: To determine the economic value of utilizing BUP-XR, relative to BUP- SL, to treat pregnant women. * Quaternary Objective: To evaluate the impact of BUP-XR, relative to BUP-SL, on infant neurodevelopment. 1.2 Study Design This is an intent-to-treat, two-arm, open-label, pragmatic randomized controlled trial. Eligible participants will be randomized in a 1:1 ratio to BUP-XR or BUP-SL, balancing on site, estimated gestational age (EGA) at time of randomization (6 weeks-18 weeks vs. 19 weeks-30 weeks), and whether they are on BUP-SL at the time of randomization (yes vs. no). Participants will be provided with study medication and attend weekly medication visits through 12 months postpartum. Participants will be invited to participate in the conceptual model assessment (CMA) sub-study, which will be used to evaluate the MOMs conceptual models. Infant caregivers will be invited to participate in the infant neurodevelopmental outcomes (INO) sub-study, which will include a 24-month child assessment. The INO data will be locked separately from the rest of the CTN?0080 database to allow CTN?0080 database lock following collection of the final (non-INO) CTN-0080 data point. 1.3 Study Population Approximately 200 pregnant women, recruited from approximately 10 sites, will be randomized into the trial. Sites that provide BUP to pregnant women in an office-based setting, offer BUP treatment following delivery for ≥12 months, and admit enough potentially eligible women to meet the target randomization rate (1.25 per month) are eligible. The study population will include pregnant women who have an EGA of 6-30 weeks at randomization, and, in the judgment of the treating provider, are good candidates for BUP-maintenance treatment. All randomized participants will be encouraged to participate in the CMA and INO sub-studies. 1.4 Treatments Participants randomized to BUP-XR will receive a weekly formulation of CAM2038 during pregnancy. During the 12-month postpartum phase, women who are breastfeeding will continue receiving BUP-XR weekly while women who are not breastfeeding will receive monthly BUP-XR. Participants randomized to BUP-SL will receive buprenorphine, with or without naloxone, based on site preference, during pregnancy and the 12-month postpartum phase. 1.5 Assessments The primary outcome is illicit opioid abstinence during pregnancy, assessed by urine drug screens (UDSs). Key secondary outcomes for the primary objective are infant NOWS severity assessed by total days of opioid treatment (derived from medical records), and mother postpartum illicit opioid abstinence assessed by UDSs. The CMA sub-study includes assessments of: 1) maternal trough BUP plasma concentrations at study weeks 3 and 5; 2) fetal non-stress test and biophysical profile at ~36 weeks EGA at maternal peak BUP plasma level; 3) maternal peak and trough BUP plasma concentrations at ~36 weeks EGA; and 4) cord and maternal plasma BUP/BUP-metabolite levels at delivery. The main economic outcome will be the incremental cost-effectiveness ratio (ICER). The main neurodevelopmental outcome of the INO sub-study will be the cognitive subscale of the Bayley Scales of Infant and Toddler DevelopmentTM, Fourth Edition (BayleyTM-4) when the child is approximately 24 months of age. Study assessments will ideally occur at the clinic site; however, as needed these visits may occur in whole or in part via telemedicine, at other institutionally-affiliated clinical sites, or elsewhere in the community (including, but not limited to, home visits, visits at other non-affiliated clinical/laboratory sites, or other community sites affording appropriate safety and confidentiality) as permitted by the institution and other regulatory bodies. For the CMA and INO sub-studies, it is likely that some study procedures will occur outside the clinic at locations deemed most appropriate by the providers performing the study assessments (including, but not limited to, the delivery hospital, an external laboratory, or other clinical location). 1.6 Primary Analysis A Type-I error rate of α=.025 will be used for the non-inferiority primary outcome analysis.

NIDA CTN协议0080 孕妇阿片类药物使用障碍的药物治疗：一种实用方法 丁丙诺啡缓释制剂与每日制剂的随机对照试验 1.1研究目标 CTN？0080包括四个目标： *主要目标：评估治疗孕妇阿片类药物使用障碍(OUD)的影响 缓释(XR)丁丙诺啡(BUP)与舌下含药(SL)的比较 BUP，关于母婴结局。假设的结果是BUP-XR，相对 对于BUP-SL，小组将： 1)在怀孕期间没有更多的非法阿片类药物使用(初级、非劣质)； 2)婴儿新生儿阿片类药物戒断综合征(NOWS)严重程度较低(关键 其次，优势)；以及 3)产后没有更多的非法阿片类药物使用(重点次要，非劣势)。 *次要目标：测试BUP-XR可以 相对于BUP-SL，改善母婴结局。 *第三个目标：确定利用BUP-XR相对于BUP-XR的经济价值 SL，用于治疗孕妇。 *第四纪目标：评估BUP-XR相对于BUP-SL对婴儿的影响 神经发育。 1.2研究设计 这是一项意向治疗、双臂、开放标签、务实的随机对照试验。合资格 参与者将以1：1的比例随机分配到BUP-XR或BUP-SL，现场平衡，估计 随机分组时的胎龄(6周-18周与19周-30周)，以及是否 他们在随机化时服用BUP-SL(是与否)。将为参与者提供学习 并在产后12个月内每周参加一次药物治疗。参与者将是 受邀参加概念模型评估(CMA)子研究，该研究将用于 评估母亲的概念模型。婴儿照顾者将被邀请参加婴儿 神经发育结果(INO)子研究，其中将包括24个月的儿童评估。这个 INO数据将与CTN？0080数据库的其余部分分开锁定，以允许CTN？0080数据库 收集最终(非INO)CTN-0080数据点后锁定。 1.3研究人群 从大约10个地点招募的大约200名孕妇将随机参加 审判。在办公室为孕妇提供BUP的网站提供BUP治疗 在≥分娩12个月后，并接纳足够的潜在符合条件的妇女来实现目标 随机化率(每月1.25)符合条件。研究人群将包括孕妇。 在随机情况下有6-30周的EGA，并且根据治疗提供者的判断，是 很适合进行臀部维护治疗。所有随机抽样的参与者都将被鼓励 参与CMA和INO分项研究。 1.4治疗 随机服用BUP-XR的参与者将在怀孕期间每周接受一次CAM2038配方。 在产后12个月期间，哺乳的妇女将继续接受BUP-XR 每周，而非母乳喂养的妇女将每月获得BUP-XR。参与者随机化 TO-BUP-SL将接受丁丙诺啡，根据网站偏好，在 怀孕和产后12个月的阶段。 1.5评估 主要结果是通过尿液药物筛查评估怀孕期间阿片类药物的非法戒断 (UDS)。主要目标的关键次要结果是婴儿NOWS的严重程度由总人数评估 阿片类药物治疗天数(来自医疗记录)和母亲产后非法阿片类药物 禁欲情况由UDS评定。CMA子项研究包括以下评估：1)母体低谷BUP 研究第3周和第5周的血药浓度；2)胎儿无负荷试验和~36周的生物物理特征 母体BUP峰值水平的周EGA；3)母体峰值和谷值的BUP血浆浓度 胎龄约36周；4)分娩时脐带和母体血浆BUP/BUP代谢物水平。主 经济成果将是增量成本效益比(ICER)。主 INO分研究的神经发育结果将是贝利量表的认知分量表 婴幼儿发展TM，第四版(Bayley TM-4)，当孩子大约24岁时 几个月大的孩子。 理想情况下，研究评估将在诊所现场进行；然而，根据需要，这些访问可能发生在 全部或部分通过远程医疗，在其他机构附属的临床站点，或在 社区(包括但不限于家访、访问其他非附属临床/实验室 网站，或提供适当安全和保密的其他社区网站) 机构和其他监管机构。对于CMA和INO分研究，很可能会有一些研究 手术将在诊所外提供者认为最合适的地点进行。 执行研究评估(包括但不限于分娩医院、外部 实验室或其他临床位置)。 1.6初步分析 第一类错误率α=0.025将用于非劣势主要结果分析。