Medication Treatment for Opioid Use Disorder in Expectant Mothers
MOMs
2 other identifiers
interventional
140
1 country
12
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2020
Typical duration for phase_3
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2019
CompletedFirst Posted
Study publicly available on registry
April 18, 2019
CompletedStudy Start
First participant enrolled
July 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2025
CompletedJune 27, 2025
June 1, 2025
4.5 years
April 9, 2019
June 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of illicit opioid-negative urine samples during pregnancy
Weekly urine samples are shipped to a central laboratory, where they are analyzed for presence of illicit opioids and/or their metabolites.
Screening through delivery
Secondary Outcomes (18)
Total days of neonatal opioid treatment during the hospital stay
Neonate discharge from hospital, typically within 1 month postpartum
Proportion of illicit opioid-negative urine samples postpartum
Delivery through 12 months postpartum
Proportion of days with study medication adherence
Screening through 12 months postpartum
Proportion of drug and alcohol-negative urine samples
Screening through 12 months postpartum
Opioid Craving Scale
Screening through delivery
- +13 more secondary outcomes
Study Arms (2)
BUP-XR
EXPERIMENTALWeekly 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.).
BUP-SL
ACTIVE COMPARATORDaily 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.).
Interventions
Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
Sublingual buprenorphine (BUP-SL), administered daily.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- T. John Winhusen, PhDlead
- National Institute on Drug Abuse (NIDA)collaborator
- The Emmes Company, LLCcollaborator
Study Sites (12)
Gateway Community Services
Jacksonville, Florida, 32204, United States
Massachusetts General Hospital HOPE Clinic
Boston, Massachusetts, 02114, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
University of New Mexico Milagro Clinic
Albuquerque, New Mexico, 87106, United States
University of Cincinnati Health Perinatal Addictions Program
Cincinnati, Ohio, 45229, United States
CODA, Inc.
Portland, Oregon, 97214, United States
Pregnancy Recovery Center at Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
University of Utah SUPeRAD Clinic
Salt Lake City, Utah, 84108, United States
Addiction Recovery Services (ARS), Swedish Medical Center
Seattle, Washington, 98107, United States
Marshall Health MARC Program
Huntington, West Virginia, 25701, United States
Related Publications (4)
Krans EE, Lewis D, Douaihy A, Lofwall MR, Kropp F, Martin PR, Sanghani RS, Cottrell JN, Winhusen TJ. Cigarette use and smoking cessation goals among pregnant women with opioid use disorder. J Subst Use Addict Treat. 2025 Dec 20:209865. doi: 10.1016/j.josat.2025.209865. Online ahead of print.
PMID: 41429292DERIVEDCash E, Cochran G, Smid MC, Charles JE, Humiston G, Wei Y, Mauerman N, Carlston K, Broussard G, Sengpraseut B, Martin PR, Winhusen TJ. Overdose risk profiles in pregnancy: Latent class analysis of pregnant individuals with opioid use disorder. J Subst Use Addict Treat. 2025 Sep 25:209809. doi: 10.1016/j.josat.2025.209809. Online ahead of print.
PMID: 41015387DERIVEDWinhusen TJ, Kropp F, Greenfield SF, Krans EE, Lewis D, Martin PR, Gordon AJ, Davies TH, Wachman EM, Douaihy A, Parker K, Xin X, Jalali A, Lofwall MR. Trauma Prevalence and Its Association With Health-related Quality of Life in Pregnant Persons With Opioid Use Disorder. J Addict Med. 2025 Jan-Feb 01;19(1):20-25. doi: 10.1097/ADM.0000000000001366. Epub 2024 Aug 6.
PMID: 39105509DERIVEDKropp FB, Smid MC, Lofwall MR, Wachman EM, Martin PR, Murphy SM, Wilder CM, Winhusen TJ. Collaborative care programs for pregnant and postpartum individuals with opioid use disorder: Organizational characteristics of sites participating in the NIDA CTN0080 MOMs study. J Subst Use Addict Treat. 2023 Jun;149:209030. doi: 10.1016/j.josat.2023.209030. Epub 2023 Apr 4.
PMID: 37023858DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
T. John Winhusen, PhD
University of Cincinnati
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- The primary outcome is assessed in a masked fashion by a central laboratory, but there is no masking for other outcomes.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor; Vice Chair and Division Director of Addiction Sciences
Study Record Dates
First Submitted
April 9, 2019
First Posted
April 18, 2019
Study Start
July 21, 2020
Primary Completion
January 31, 2025
Study Completion
January 31, 2025
Last Updated
June 27, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
Data will be transmitted by the study Data and Statistics Center to the designated party for de-identification, posting, storing, and archiving on NIDA's Data Share website. Data Share is an online repository of data from studies funded by the National Institute on Drug Abuse. All de-identified individual participant data is expected to be made available.