Opioid-Related DisordersPhase 3MOMsNCT03918850
Medication Treatment for Opioid Use Disorder in Expectant Mothers
A Phase 3 study testing Buprenorphine Injection and Buprenorphine Sublingual Product in people with Opioid-Related Disorders and Drug Addiction, run by T. John Winhusen, PhD at 12 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 41 years, women only
- Conditions the study is for
- Opioid-Related Disorders, Drug Addiction, Pregnancy Related
- What is being tested?
- Buprenorphine Injection and Buprenorphine Sublingual Product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 12 sitesUnited States
- Study dates
- 21 Jul 2020to 31 Jan 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 41 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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:
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- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
University of New Mexico Milagro Clinic
Albuquerque, New Mexico, 87106
Massachusetts General Hospital HOPE Clinic
Boston, Massachusetts, 02114
Boston Medical Center
Boston, Massachusetts, 02118
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Cincinnati Health Perinatal Addictions Program
Cincinnati, Ohio, 45229
Marshall Health MARC Program
Huntington, West Virginia, 25701
Gateway Community Services
Jacksonville, Florida, 32204
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Pregnancy Recovery Center at Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
CODA, Inc.
Portland, Oregon, 97214
University of Utah SUPeRAD Clinic
Salt Lake City, Utah, 84108
Addiction Recovery Services (ARS), Swedish Medical Center
Seattle, Washington, 98107
About this study
Official title: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs): a Pragmatic Randomized Trial Comparing Extended-release and Daily Buprenorphine Formulations
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).
Read the detailed description
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.
- Conditions
- Opioid-Related Disorders, Drug Addiction, Pregnancy Related, Substance Abuse, Drug Abuse, Neonatal Abstinence Syndrome
- Being tested
- Buprenorphine Injection, Buprenorphine Sublingual Product
- Keywords
- CTN-0080, clinical trials network, medication assisted treatment
- Medical subject headings
- Opioid-Related Disorders, Substance-Related Disorders, Neonatal Abstinence Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buprenorphine InjectionDrug
Also called CAM2038
Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
Buprenorphine Sublingual ProductDrug
Also called Subutex, Suboxone
Sublingual buprenorphine (BUP-SL), administered daily.
| Study group | Role | What they receive |
|---|---|---|
| BUP-XR | Experimental | 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.). Receives: Drug: Buprenorphine Injection |
| BUP-SL | Active comparator | 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.). Receives: Drug: Buprenorphine Sublingual Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage 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. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants.
Measured: From screening (at 6-30 weeks estimated gestational age) to delivery, an average of 10-34 weeks
Secondary outcomes (17)
Percentage of Illicit Opioid-negative Urine Samples Postpartum
Weekly urine samples are shipped to a central laboratory, where they are analyzed for presence of illicit opioids and/or their metabolites.
Measured: Delivery through 12 months postpartum
Percentage of Days With Study Medication Adherence During Pregnancy
Adherence to treatment from screening to delivery, checked weekly. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants.
Measured: From screening (at 6-30 weeks estimated gestational age) to delivery, an average of 10-34 weeks
Percentage of Days With Study Medication Adherence - Postpartum
Adherence to treatment from delivery through 12 months postpartum, checked weekly.
Measured: Delivery through 12 months postpartum
Percentage of Drug and Alcohol-negative Urine Samples During Pregnancy
Weekly urine samples are shipped to a central laboratory, where they are analyzed for presence of alcohol, illicit drugs and/or their metabolites. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants.
Measured: From screening (at 6-30 weeks estimated gestational age) to delivery, an average of 10-34 weeks
Percentage of Drug and Alcohol-negative Urine Samples - Postpartum Phase
Weekly urine samples are shipped to a central laboratory, where they are analyzed for presence of alcohol, illicit drugs and/or their metabolites, excluding cotinine.
Measured: Delivery through 12 months postpartum
Opioid Craving Scale - Pregnancy
The scale consists of 3 items, measuring craving, cue-induced craving, and likelihood of using, rated on a visual analogue scale from 0-10. The total is calculated by averaging the 3 item scores. Higher scores indicate greater levels of opioid craving. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants. The measure was assessed at randomization (6-30 weeks estimated gestational age), two weeks post randomization and then monthly until delivery, average score reported.
Measured: Assessed at randomization (6-30 weeks estimated gestational age), two weeks post randomization and then monthly until delivery
Opioid Craving Scale - Postpartum
The scale measures craving, cue-induced craving, and likelihood of using, rated on a visual analogue scale from 0-10. The total is calculated by averaging the 3 item scores. Higher scores indicate greater levels of opioid craving. The measure was assessed at months 1, 3, 6, 9, and 12 post-delivery, average score reported
Measured: Assessed at months 1, 3, 6, 9, and 12 post-delivery
Adequacy of Prenatal Care Utilization Index
The information was derived from either medical records or the birth certificate. Information was not obtained for 74 participants.
Measured: At delivery
Short Opiate Withdrawal Scale (SOWS)-Gossop - Pregnancy
Measure of maternal opioid withdrawal symptoms. The Short Opiate Withdrawal Scale-Gossop has scores rated on a scale of 0 (none) to 3 (severe) per question. The total score of the SOWS-Gossop ranges from 0-30. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants. The measure was assessed at randomization (6-30 weeks estimated gestational age), two weeks post randomization and then monthly until delivery, average score reported.
Measured: Assessed at randomization (6-30 weeks estimated gestational age), two weeks post randomization and then monthly until delivery
Short Opiate Withdrawal Scale (SOWS)-Gossop - Postpartum
Measure of maternal opioid withdrawal symptoms. The Short Opiate Withdrawal Scale-Gossop has scores rated on a scale of 0 (none) to 3 (severe) per question. The total score of the SOWS-Gossop ranges from 0-30. The measure was assessed at months 1, 3, 6, 9, and 12 post-delivery, average score reported.
Measured: Assessed at months 1, 3, 6, 9, and 12 post-delivery
Opioid Medication for Neonatal Opioid Withdrawal Syndrome (NOWS) Symptoms
Use of opioid medication for NOWS symptoms will be abstracted from the medical record.
Measured: Neonate discharge from hospital, typically within 1 month postpartum
Total Days of Neonatal Opioid Treatment During the Hospital Stay
Number of days of NOWS treatment for those infants that did receive it, abstracted from the medical record.
Measured: Neonate discharge from hospital, typically within 1 month postpartum
Infant Hospital Length of Stay
Infant hospital length of stay (LOS) defined as the infant's age, in days, at discharge will be abstracted from the medical record. (all infants)
Measured: Neonate discharge from hospital, typically within 1 month postpartum
Neonatal Opioid Withdrawal Syndrome (NOWS) Peak Score
NOWS peak score will be abstracted from the medical record. The scale used is the Finnegan-modified; the score ranges from 0-46, a score of 8 or higher indicates withdrawal.
Measured: Neonate discharge from hospital, typically within 1 month postpartum
Custody at Discharge
For example, whether the infant is discharged in custody of mother, other relative, foster/adoptive family, etc. This will be abstracted from the medical record. Maternal custody - number \& percentage.
Measured: Neonate discharge from hospital, typically within 1 month postpartum
Child Protective Services Open Case
Whether or not there is an open child protective services at discharge (yes/no) will be abstracted from the medical record. Percentage of cases open with child protective services.
Measured: Neonate discharge from hospital, typically within 1 month postpartum
Ages and Stages Questionnaire, Third Edition (ASQ-3)
To screen for developmental issues in the infant. Developmental issues at 12 months - percentage. Developmental issues assessed with The Ages and Stages Questionnaire, third edition scores each item as Yes (10 points), Sometimes (5 points), or Not Yet (0 points), with total scores compared to cutoffs to identify delays.
Measured: 12 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start21 Jul 2020
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Opioid-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an intent-to-treat, two-arm, open-label, pragmatic randomized controlled trial.
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- T. John Winhusen, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), The Emmes Company, LLC
- Responsible party
- Sponsor-investigator, T. John Winhusen, PhD, University of Cincinnati
- Investigators
- T. John Winhusen, PhD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03918850
- Sponsor's protocol ID
- 2019-0429-1
- Other IDs
- UG1DA013732
- Acronym
- MOMs
- Status last verified
- May 2026
- First submitted
- 9 Apr 2019
- Last updated
- 4 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Winhusen TJ, Lofwall MR, Kropp F, Lewis D, Smid MC, Young JL, Hodgkins C, Krans EE, Hansen Z, Wachman EM, Schiff DM, Guille C, Rudolf V, Chowdhury T, Leeman L, Lewis M, Matthews AG, Cochran G, King J, Wilder C, Rosa C. Extended-Release vs Sublingual Buprenorphine in Pregnancy Through 12 Months Post Partum: A Randomized Clinical Trial. JAMA Intern Med. 2026 May 1;186(5):533-543. doi: 10.1001/jamainternmed.2026.0057.
PubMed 41837971Krans 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.
PubMed 41429292Cash 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.
PubMed 41015387Snyder AM, Math S, Campbell K, Schiff DM, Wheeler A, Carlston K, Gordon AJ, Winhusen TJ, Cochran G, Smid MC. Protocol Commentary for the SUCCESS (Successful Recruitment and Retention in a Randomized Controlled Trial of Pregnant Participants with Opioid Use Disorder) Study. Subst Use Addctn J. 2025 Oct;46(4):1040-1046. doi: 10.1177/29767342251334490. Epub 2025 Jul 11.
PubMed 40643178Winhusen 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.
PubMed 39105509Kropp 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.
PubMed 37023858
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs): a Pragmatic Randomized Trial Comparing Extended-release and Daily Buprenorphine Formulations
- ClinicalTrials.gov ID
- NCT03918850
- Acronym / sponsor ID
- MOMs / 2019-0429-1
- Conditions
- Opioid-Related Disorders, Drug Addiction, Pregnancy Related, Substance Abuse, Drug Abuse, Neonatal Abstinence Syndrome
- Keywords
- CTN-0080, clinical trials network, medication assisted treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- T. John Winhusen, PhDUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), The Emmes Company, LLC
- Study start
- 21 Jul 2020 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 18 Apr 2019 (actual)
- Results
- Posted 4 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an intent-to-treat, two-arm, open-label, pragmatic randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| BUP-XR | Experimental | Drug: Buprenorphine InjectionWeekly 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 comparator | Drug: Buprenorphine Sublingual ProductDaily 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.). |
Who may qualify
- Ages
- 18 to 41 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (13 listed)
- 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:
- 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:
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Buprenorphine InjectionAlso: CAM2038Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR). | Drug | BUP-XR |
| Buprenorphine Sublingual ProductAlso: Subutex, SuboxoneSublingual buprenorphine (BUP-SL), administered daily. | Drug | BUP-SL |
Primary outcome
Percentage of Illicit Opioid-negative Urine Samples During Pregnancy
Time frame: From screening (at 6-30 weeks estimated gestational age) to delivery, an average of 10-34 weeks
Weekly urine samples are shipped to a central laboratory, where they are analyzed for presence of illicit opioids and/or their metabolites. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants.
17 secondary outcomes
Percentage of Illicit Opioid-negative Urine Samples Postpartum
Time frame: Delivery through 12 months postpartum
Percentage of Days With Study Medication Adherence During Pregnancy
Time frame: From screening (at 6-30 weeks estimated gestational age) to delivery, an average of 10-34 weeks
Percentage of Days With Study Medication Adherence - Postpartum
Time frame: Delivery through 12 months postpartum
Percentage of Drug and Alcohol-negative Urine Samples During Pregnancy
Time frame: From screening (at 6-30 weeks estimated gestational age) to delivery, an average of 10-34 weeks
Percentage of Drug and Alcohol-negative Urine Samples - Postpartum Phase
Time frame: Delivery through 12 months postpartum
Opioid Craving Scale - Pregnancy
Time frame: Assessed at randomization (6-30 weeks estimated gestational age), two weeks post randomization and then monthly until delivery
Opioid Craving Scale - Postpartum
Time frame: Assessed at months 1, 3, 6, 9, and 12 post-delivery
Adequacy of Prenatal Care Utilization Index
Time frame: At delivery
Short Opiate Withdrawal Scale (SOWS)-Gossop - Pregnancy
Time frame: Assessed at randomization (6-30 weeks estimated gestational age), two weeks post randomization and then monthly until delivery
Short Opiate Withdrawal Scale (SOWS)-Gossop - Postpartum
Time frame: Assessed at months 1, 3, 6, 9, and 12 post-delivery
Opioid Medication for Neonatal Opioid Withdrawal Syndrome (NOWS) Symptoms
Time frame: Neonate discharge from hospital, typically within 1 month postpartum
Total Days of Neonatal Opioid Treatment During the Hospital Stay
Time frame: Neonate discharge from hospital, typically within 1 month postpartum
Infant Hospital Length of Stay
Time frame: Neonate discharge from hospital, typically within 1 month postpartum
Neonatal Opioid Withdrawal Syndrome (NOWS) Peak Score
Time frame: Neonate discharge from hospital, typically within 1 month postpartum
Custody at Discharge
Time frame: Neonate discharge from hospital, typically within 1 month postpartum
Child Protective Services Open Case
Time frame: Neonate discharge from hospital, typically within 1 month postpartum
Ages and Stages Questionnaire, Third Edition (ASQ-3)
Time frame: 12 months postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41837971Winhusen TJ, Lofwall MR, Kropp F, Lewis D, Smid MC, Young JL, Hodgkins C, Krans EE, Hansen Z, Wachman EM, Schiff DM, Guille C, Rudolf V, Chowdhury T, Leeman L, Lewis M, Matthews AG, Cochran G, King J, Wilder C, Rosa C. Extended-Release vs Sublingual Buprenorphine in Pregnancy Through 12 Months Post Partum: A Randomized Clinical Trial. JAMA Intern Med. 2026 May 1;186(5):533-543. doi: 10.1001/jamainternmed.2026.0057.
- Derived from this study: PubMed 41429292Krans 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.
- Derived from this study: PubMed 41015387Cash 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.
- Derived from this study: PubMed 40643178Snyder AM, Math S, Campbell K, Schiff DM, Wheeler A, Carlston K, Gordon AJ, Winhusen TJ, Cochran G, Smid MC. Protocol Commentary for the SUCCESS (Successful Recruitment and Retention in a Randomized Controlled Trial of Pregnant Participants with Opioid Use Disorder) Study. Subst Use Addctn J. 2025 Oct;46(4):1040-1046. doi: 10.1177/29767342251334490. Epub 2025 Jul 11.
- Derived from this study: PubMed 39105509Winhusen 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.
- Derived from this study: PubMed 37023858Kropp 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.
- Individual participant dataSharing planned: Yes. 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.
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Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Active, not recruitingPhase 2
Wellcome Leap Psilocybin for OUD
Opioid Use Disorder
Recruiting
Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial
Opioid Use Disorder, Opioid Misuse
Active, not recruiting
EXHIT ENTRE Implementation Trial of High Intensity Versus Low Intensity Strategy
Substance Use Disorders, Opioid Use Disorder, Severe
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
T. John Winhusen, PhD principal investigator
University of Cincinnati
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Buprenorphine Injection and Buprenorphine Sublingual Product in people with Opioid-Related Disorders and Drug Addiction, run by T. John Winhusen, PhD at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Illicit Opioid-negative Urine Samples During Pregnancy (time frame: From screening (at 6-30 weeks estimated gestational age) to delivery, an average of 10-34 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03918850, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.