Medically-supervised withdrawal vs. agonist maintenance in the treatment of pregnant women with opioid use disorder: Maternal, fetal, and neonatal outcomes

治疗患有阿片类药物使用障碍的孕妇的医学监督戒断与激动剂维持治疗：孕产妇、胎儿和新生儿结局

• 批准号: 10375543
• 负责人: Sarah H Heil
• 金额: $ 64.99万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-07-15 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10375543
• 关键词: Abruptio Placentae; Academic Medical Centers; Address; Agonist; Birth; Body Size; Buprenorphine; Case Management; Characteristics; Clinic; Cohort Studies; Comprehensive Health Care; Counseling; Data; Discipline of obstetrics; Drug Metabolic Detoxication; Drug Screening; Exposure to; Family; Government; Health Services; Incidence; Individual; Length; Length of Stay; Literature; Maintenance; Maternal Health; Medical; Medical Societies; Methodology; Morphine; Mothers; Neonatal; Neonatal Abstinence Syndrome; Opioid; Outcome; Participant; Patients; Personal Satisfaction; Pharmaceutical Preparations; Pharmacological Treatment; Policies; Population; Postpartum Period; Pregnancy; Pregnant Women; Premature Birth; Prospective Studies; Protocols documentation; Provider; Psychiatry; Public Health; Recommendation; Recording of previous events; Relapse; Reporting; Research; Research Design; Safety; Science; Services; Site; Social Work; Supervision; Urine; Visit; Withdrawal; Woman; base; clinical care; common treatment; delivery complications; disorder later incidence prevention; evidence base; fetal; follow-up; high risk population; innovation; intraamniotic infection; maternal outcome; neonatal health; neonatal outcome; neonate; opioid agonist therapy; opioid use disorder; opioid withdrawal; preference; prenatal exposure; pressure; prospective; recruit; response; social; social factors; standard of care; substance use; systematic review; treatment comparison; treatment group

PROJECT SUMMARY/ABSTRACT Background. Recommendations for opioid agonist treatment (OAT) and against medically-supervised withdrawal (MSW) were based on early reports associating withdrawal with maternal relapse and fetal demise. While our recent systematic review did not support an association between MSW and fetal demise, relapse remains a significant concern with rates ranging from 0% to 100%. A retrospective report also suggests more delivery complications at delivery with MSW as compared to OAT. Neonatal outcomes after maternal MSW, however, are more positive, with retrospective reports suggesting MSW decreases the incidence of neonatal abstinence syndrome (NAS), reduces the amount of medication needed to treat NAS, and shortens neonatal length of hospital stay as compared to OAT. Given the literature’s mixed findings and methodological weaknesses, controlled prospective studies are needed. Study Design. The proposed study will be a four site, controlled, prospective, longitudinal, matched cohort study in which pregnant women with OUD who choose MSW at treatment entry (n=120) will be propensity- score matched with pregnant women with OUD who choose OAT at treatment entry (n=240) using maternal demographic, social, personal, and substance use history data collected at study entry. Women choosing MSW will undergo a 5-7 day withdrawal using buprenorphine; those choosing OAT will be inducted onto buprenorphine. All will receive comprehensive clinical care (obstetrical visits, group and individual counseling, case management, psychiatry services, and urine drug screening) and complete monthly research assessments with study staff. There will be a full assessment of maternal and neonatal health and well-being at birth, a minimum 4-day assessment of NAS, and a maternal postpartum assessment. Aim 1: (Exploratory) To determine the extent to which pregnant women with OUD seeking MSW differ from those seeking OAT in terms of demographic, social, personal, and substance use history characteristics. Aim 2: (Inferential) To examine the extent to which pregnant women with OUD seeking MSW differ from those seeking OAT in terms of maternal and neonatal outcomes. Aim 3. (Descriptive) To assess the ability of participant treatment entry characteristics to discriminate between (a) MSW participants who successfully complete their withdrawal protocol from MSW participants who do not; (b) MSW participants who successfully complete MSW and are opioid-negative at delivery from MSW participants who successfully complete their withdrawal protocol but discontinue treatment and are opioid-positive at delivery; and (c) participants who successfully complete MSW and are opioid-negative at delivery from participants who remain in OAT and are opioid-negative at delivery. Public Health Impact. This study will provide science- based evidence that addresses significant gaps in the treatment of OUD during pregnancy to be used by government, medical societies, providers and patients to inform treatment of mothers and neonates.

项目摘要/摘要 背景。阿片激动剂治疗（OAT）的建议和针对医学监督的建议 戒断（MSW）是基于早期报告，将戒断与母校接力和胎儿相关联 灭亡。尽管我们最近的系统评价不支持MSW与胎儿灭亡之间的关联，但 继电器仍然是一个重大问题，利率在0％至100％之间。回顾性报告 与燕麦相比，建议与MSW交付时更多的交付并发症。新生儿结果之后 然而，母体MSW更为积极，回顾性报告表明MSW降低了 新生儿禁欲综合征（NAS）的发生率减少了治疗NAS所需的药物量 与燕麦相比，缩短了新生儿住院时间。考虑到文献的混合发现和 需要方法弱点，需要对照的前瞻性研究。 研究设计。拟议的研究将是一个四个地点，受控，前瞻性，纵向，匹配的队列 研究中，有OUD孕妇在治疗入境时选择MSW（n = 120）是有望的 - 分数与使用母体在治疗入口时选择燕麦的孕妇的孕妇相匹配 人口，社会，个人和物质使用研究入门时收集的历史数据。妇女选择 MSW将使用丁丙诺啡进行5-7天的撤回；那些选择燕麦的人将被引入 丁丙诺啡。所有人都将获得全面的临床护理（产科访问，团体和个人 咨询，病例管理，精神病学服务和尿液药物筛查）和每月一次 研究人员的研究评估。将对孕产妇和新生儿健康进行全面评估， 出生时的幸福感，NAS至少4天评估以及产后重大评估。 目标1 ：（探索性）确定与Oud寻求MSW不同的孕妇不同的程度 那些在人口，社会，个人和物质使用历史特征方面寻求燕麦的人。 目的2 ：（推论）检查具有Oud寻求MSW的孕妇与不同的程度 那些在母亲和新生儿结果方面寻求燕麦的人。目标3。（描述性）评估能力 参与治疗的特征以区分（a）成功的MSW参与者 从没有的MSW参与者那里完成他们的撤回协议； （b）MSW参与者 成功完成MSW，是MSW参与者交付的阿片类药物阴性 完成其撤回方案，但停止治疗，并且在分娩时是阿片类药物阳性的； （c） 成功完成MSW并为参与者提供阿片类药物阴性的参与者 留在燕麦中，并在分娩时为阿片类药物。公共卫生影响。这项研究将提供科学 - 基于解决怀孕期间OUD治疗差距的显着差距的基于证据 政府，医疗社会，提供者和患者，以告知母亲和新生儿的治疗。

项目成果

Challenges and opportunities during the COVID-19 pandemic: Treating patients for substance use disorders during the perinatal period.

• DOI: 10.1016/j.ypmed.2021.106742
• 发表时间: 2021-11
• 期刊: Preventive medicine
• 影响因子: 5.1
• 作者: Jones HE;Hairston E;Lensch AC;Marcus LK;Heil SH
• 通讯作者: Heil SH

Changing Outdated Methadone Regulations That Harm Pregnant Patients.

• DOI: 10.1097/adm.0000000000000720
• 发表时间: 2021-04-01
• 期刊: Journal of addiction medicine
• 影响因子: 5.5
• 作者: McCarthy JJ;Jones HE;Terplan M;Rudolf VP;von Klimo MC
• 通讯作者: von Klimo MC

Comprehensive Treatment for Pregnant and Parenting Women with Substance Use Disorders and Their Children: The UNC Horizons Story.

对患有药物滥用障碍的孕妇和育儿妇女及其孩子的综合治疗：北卡罗来纳大学地平线故事。

• DOI: 10.1007/s10995-023-03870-7
• 发表时间: 2024
• 期刊: Maternal and child health journal
• 影响因子: 2.3
• 作者: Jones,HendréeE;Andringa,Kim;Carroll,Senga;Johnson,Elisabeth;Horton,Evette;O'Grady,Kevin;Stanford,Deborah;Renz,Connie;Thorp,John
• 通讯作者: Thorp,John

Letter-in-reply.

回信。

• DOI: 10.1097/adm.0000000000000589
• 发表时间: 2020
• 期刊: Journal of addiction medicine
• 影响因子: 5.5
• 作者: Jones,HendréeE;Kaltenbach,Karol;Benjamin,Tara;Wachman,ElishaM;O'Grady,KevinE
• 通讯作者: O'Grady,KevinE

Pregnant Patients Using Opioids: Treatment Access Barriers in the Age of COVID-19.

• DOI: 10.1097/adm.0000000000000826
• 发表时间: 2022-01-01
• 期刊: Journal of addiction medicine
• 影响因子: 5.5
• 作者: Lensch AC;Hairston E;Carter G;Jones HE
• 通讯作者: Jones HE