New hope for pregnant women battling opioid addiction: monthly shot vs daily pill
NCT ID NCT03918850
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a once-monthly injection of buprenorphine works as well as daily pills to treat opioid use disorder in 140 pregnant women. The goal was to see if the monthly shot could reduce illicit opioid use during pregnancy and after birth. Results help doctors choose the best treatment for both mother and baby.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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140 people
The number who actually took part.
- Started
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Jul 2020
- Finished
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Jan 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 41 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Potential participants must: 1. be 18-41 years of age 2. 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 3. have a single fetus pregnancy (can be based on self-report if an objective assessment is unavailable) 4. 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 5. be willing to be randomized to BUP-XR or BUP-SL and to comply with study procedures, including weekly Medication Check Visits 6. 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 7. be enrolled in outpatient addiction treatment at a participating site (e.g., have completed intake) 8. be able to understand the study, and having understood, provide written informed consent in English Exclusion Criteria: Potential participants must not: 1. have a physiological dependence on alcohol or sedatives requiring medical detoxification 2. 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) 3. 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 4. 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; 5. be currently receiving methadone or naltrexone for the treatment of OUD; 6. 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; 7. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Addiction Recovery Services (ARS), Swedish Medical Center
Seattle, Washington, 98107, United States
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Boston Medical Center
Boston, Massachusetts, 02118, United States
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CODA, Inc.
Portland, Oregon, 97214, United States
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Gateway Community Services
Jacksonville, Florida, 32204, United States
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Marshall Health MARC Program
Huntington, West Virginia, 25701, United States
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Massachusetts General Hospital HOPE Clinic
Boston, Massachusetts, 02114, United States
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Medical University of South Carolina
Charleston, South Carolina, 29425, United States
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Pregnancy Recovery Center at Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213, United States
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University of Cincinnati Health Perinatal Addictions Program
Cincinnati, Ohio, 45229, United States
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University of New Mexico Milagro Clinic
Albuquerque, New Mexico, 87106, United States
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University of Utah SUPeRAD Clinic
Salt Lake City, Utah, 84108, United States
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Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
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Other studies related to the condition(s) this trial covers.
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