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New hope for pregnant women battling opioid addiction: monthly shot vs daily pill

NCT ID NCT03918850

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

140 people

The number who actually took part.

Started

Jul 2020

Finished

Jan 2025

Lead sponsor

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

18 to 41 years

Sex

Female participants only

Healthy volunteers

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

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

  • Addiction Recovery Services (ARS), Swedish Medical Center

    Seattle, Washington, 98107, United States

  • Boston Medical Center

    Boston, Massachusetts, 02118, United States

  • CODA, Inc.

    Portland, Oregon, 97214, United States

  • Gateway Community Services

    Jacksonville, Florida, 32204, United States

  • Marshall Health MARC Program

    Huntington, West Virginia, 25701, United States

  • Massachusetts General Hospital HOPE Clinic

    Boston, Massachusetts, 02114, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Pregnancy Recovery Center at Magee-Womens Hospital of UPMC

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Cincinnati Health Perinatal Addictions Program

    Cincinnati, Ohio, 45229, United States

  • University of New Mexico Milagro Clinic

    Albuquerque, New Mexico, 87106, United States

  • University of Utah SUPeRAD Clinic

    Salt Lake City, Utah, 84108, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

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