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.

项目概要/摘要 背景：阿片类药物激动剂治疗（OAT）的建议和反对医疗监督的建议 戒断（MSW）是基于早期报告，将戒断与母亲复发和胎儿 虽然我们最近的系统评价不支持城市固体废弃物与胎儿死亡之间的关联， 回顾性报告还指出，复发率仍然是一个重大问题，复发率从 0% 到 100% 不等。 表明与 OAT 相比，MSW 分娩时的分娩并发症更多。 然而，孕产妇城市固体废物的影响更为积极，回顾性报告表明城市固体废物降低了 新生儿戒断综合征 (NAS) 的发生率，减少治疗 NAS 所需的药物量， 与 OAT 相比，缩短了新生儿的住院时间。 方法学上的弱点，需要对照前瞻性研究。 研究设计。拟议的研究将是一个四中心、对照、前瞻性、纵向、匹配队列。 在一项研究中，患有 OUD 的孕妇在治疗开始时选择 MSW（n=120）将有以下倾向： 使用母亲的评分与在治疗开始时选择 OAT 的 OUD 孕妇 (n=240) 进行匹配 在研究开始时收集的人口统计、社会、个人和药物使用历史数据。 MSW 将使用丁丙诺啡进行 5-7 天的戒断；那些选择 OAT 的人将被引入 所有人都将接受全面的临床护理（产科就诊、团体和个人）。 咨询、病例管理、精神病学服务和尿液药物筛查）并每月完成一次 与研究人员进行研究评估将对孕产妇和新生儿健康进行全面评估。 出生时的健康状况、至少 4 天的 NAS 评估以及产妇产后评估。 目标 1：（探索性）确定寻求 MSW 的 OUD 孕妇与寻求 MSW 的孕妇有何不同 那些在人口、社会、个人和物质使用历史特征方面寻求 OAT 的人。 目标 2：（推论）检查寻求 MSW 的 OUD 孕妇与寻求 MSW 的孕妇有何不同 目标 3.（描述性）评估能力。 的治疗进入特征来区分 (a) 成功的 MSW 参与者 (b) 完成退出协议的城市固体废物参与者与未完成退出协议的城市固体废物参与者； 成功完成 MSW 且在交付时呈阿片类药物阴性的 MSW 参与者 完成戒断方案但停止治疗并且在分娩时呈阿片类药物阳性；以及 (c) 成功完成 MSW 且在分娩时阿片类药物呈阴性的参与者 仍处于 OAT 状态并且在分娩时阿片类药物呈阴性。这项研究将提供科学依据。 解决怀孕期间 OUD 治疗中的重大差距的证据，供 政府、医学会、医疗服务提供者和患者为母亲和新生儿的治疗提供信息。

项目成果

Reasons for past abortions among women in treatment for opioid use disorder.

接受阿片类药物使用障碍治疗的女性过去堕胎的原因。

• 发表时间: 2024-03
• 作者: Harfmann, Roxanne F;Heil, Sarah H;Cannon, Lindsay M;Dalton, Vanessa K;Kusunoki, Yasamin;Kock, Loren S;MacAfee, Lauren K
• 通讯作者: MacAfee, Lauren K

The Stimulant Crisis Intertwined With the Opioid Crisis: A Compassionate Response for Dyadic Health and Well-Being.

兴奋剂危机与阿片类药物危机交织在一起：对二元健康和福祉的富有同情心的反应。

• 发表时间: 2021-08
• 影响因子: 12.7
• 作者: Jones, Hendrée E;Nakagawa, Jenna;Johnson, Elisabeth
• 通讯作者: Johnson, Elisabeth

Increasing knowledge about recovery-related life domains among pregnant and parenting women in comprehensive substance use disorder treatment: The Art of Addiction Recovery Program.

在综合药物使用障碍治疗中增加孕妇和育儿妇女对康复相关生活领域的了解：成瘾康复计划的艺术。

• 发表时间: 2022-03-01
• 影响因子: 4.2
• 作者: Jones, Hendrée E;Apsley, Hannah B;Cocowitch, Anya;Merrill, Tina;McGlothlin, Sarah;Middlesteadt;Andringa, Kim;O'Grady, Kevin E
• 通讯作者: O'Grady, Kevin E

Letter-in-reply.

回信。

• 发表时间: 2020
• 作者: Jones, Hendrée E;Kaltenbach, Karol;Benjamin, Tara;Wachman, Elisha M;O'Grady, Kevin E
• 通讯作者: O'Grady, Kevin E

Contingency management interventions for abstinence from cigarette smoking in pregnancy and postpartum: A systematic review and meta-analysis.

怀孕和产后戒烟的应急管理干预措施：系统评价和荟萃分析。

• 发表时间: 2023-11
• 影响因子: 5.1
• 作者: Kock, Loren S;Erath, Tyler G;Coleman, Sulamunn R M;Higgins, Stephen T;Heil, Sarah H
• 通讯作者: Heil, Sarah H