Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs): a Pragmatic Randomized Trial Comparing Extended-release and Daily Buprenorphine Formulations
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 24
- 主要终点
- Proportion of illicit opioid-negative urine samples during pregnancy
研究概览
简要总结
The primary objective of this study is to evaluate the impact of treating opioid use disorder (OUD) in pregnant women with extended-release buprenorphine (BUP-XR), compared to sublingual buprenorphine (BUP-SL), on mother and infant outcomes. The primary hypothesis is that the BUP-XR group will not have greater illicit opioid use than the BUP-SL group during pregnancy (non-inferiority).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The primary outcome is assessed in a masked fashion by a central laboratory, but there is no masking for other outcomes.
入排标准
- 年龄范围
- 18 Years 至 41 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Potential participants must:
- •be 18-41 years of age
- •be pregnant with an estimated gestational age (EGA) of 6 - 30 weeks at randomization, has evidence of a viable intrauterine pregnancy if EGA < 12 weeks and is not planning to terminate the pregnancy
- •have a single fetus pregnancy (can be based on self-report if an objective assessment is unavailable)
- •meet Diagnostic and Statistical Manual (DSM)-5 criteria for moderate/severe OUD and be a good candidate for BUP maintenance and/or be currently prescribed BUP for the treatment of OUD
- •be willing to be randomized to BUP-XR or BUP-SL and to comply with study procedures, including weekly Medication Check Visits
- •be planning to deliver at one of the hospitals for which the BORN survey was completed and that: a) has a written protocol for the management of neonatal abstinence syndrome (NAS) / neonatal withdrawal syndrome (NOWS), b) offers rooming-in while infants are being observed for NAS/NOWS; and c) does not send infants home on opioids for the treatment of NAS/NOWS
- •be enrolled in outpatient addiction treatment at a participating site (e.g., have completed intake)
- •be able to understand the study, and having understood, provide written informed consent in English
排除标准
- •Potential participants must not:
- •have a physiological dependence on alcohol or sedatives requiring medical detoxification
- •have a psychiatric condition that, in the judgment of the site medical clinician (MC), would make study participation unsafe or which would make treatment compliance difficult. Examples include:
- •Suicidal or homicidal ideation requiring immediate attention
- •Severe, inadequately-treated mental health disorder (e.g., active psychosis, uncontrolled bipolar disorder)
- •have a medical condition that, in the judgment of the study MC, would make study participation unsafe or which would make treatment compliance difficult. Medical conditions that may compromise participant safety or study conduct include, but are not limited to, allergy/sensitivity to study medications and the following based on clinical labs:
- •aspartate aminotransferase (AST) / alanine aminotransferase (ALT) greater than 5X upper limit of normal
- •serum creatinine greater than 1.5X upper limit of normal
- •total bilirubin greater than 1.5X upper limit of normal
- •be currently in jail, prison or any inpatient overnight facility as required by court of law or have pending legal action or other situation (e.g., unstable living arrangements) that, in the judgement of the site investigator, could prevent participation in the study or in any study activities;
- •be currently receiving methadone or naltrexone for the treatment of OUD;
- •be enrolled in or planning to enroll in treatment beyond the level 3.3 (Clinically Managed Population-Specific High-Intensity Residential Services) of the American Society of Addiction Medicine criteria; for level 3.3, the participant must have the ability to leave the facility unaccompanied by staff as needed;
- •be enrolled in or planning to enroll in: a) a trial testing medication for managing OUD during pregnancy; b) research testing an intervention for substance use disorder or NOWS in their infant unless they are willing to provide a release for the research records.
研究组 & 干预措施
BUP-SL
Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase.
The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
干预措施: Buprenorphine Sublingual Product (Drug)
BUP-XR
Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly.
The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
干预措施: Buprenorphine Injection (Drug)
结局指标
主要结局
Proportion of illicit opioid-negative urine samples during pregnancy
时间窗: Screening through delivery
Weekly urine samples are shipped to a central laboratory, where they are analyzed for presence of illicit opioids and/or their metabolites.
次要结局
- Total days of neonatal opioid treatment during the hospital stay(Neonate discharge from hospital, typically within 1 month postpartum)
- Proportion of days with study medication adherence(Screening through 12 months postpartum)
- Opioid Craving Scale(Delivery through 12 months postpartum)
- Proportion of illicit opioid-negative urine samples postpartum(Delivery through 12 months postpartum)
- Short Opiate Withdrawal Scale (SOWS)-Gossop(Screening through 12 months postpartum)
- Proportion of drug and alcohol-negative urine samples(Screening through 12 months postpartum)
- Opioid Medication for Neonatal Opioid Withdrawal Syndrome (NOWS) Symptoms(Neonate discharge from hospital, typically within 1 month postpartum)
- Adjunct Medications(Neonate discharge from hospital, typically within 1 month postpartum)
- Diagnosis code for Neonatal Opioid Withdrawal Syndrome (NOWS)(Neonate discharge from hospital, typically within 1 month postpartum)
- Custody at discharge(Neonate discharge from hospital, typically within 1 month postpartum)
- Medications at discharge(Neonate discharge from hospital, typically within 1 month postpartum)
- Child protective services open case(Neonate discharge from hospital, typically within 1 month postpartum)
- Ages and Stages Questionnaire, third edition (ASQ-3)(12 months postpartum)
- Neonatal Opioid Withdrawal Syndrome (NOWS) Peak Score(Neonate discharge from hospital, typically within 1 month postpartum)
- Adequacy of Prenatal Care Utilization Index(At delivery)
- Infant Hospital Length of Stay(Neonate discharge from hospital, typically within 1 month postpartum)
研究者
T. John Winhusen, PhD
Professor; Vice Chair and Division Director of Addiction Sciences
University of Cincinnati