Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03918850 · ClinicalTrials.gov registry record · Phase 3
Medication Treatment for Opioid Use Disorder in Expectant Mothers
A Phase 3 study of Pregnancy Related and Substance Abuse, sponsored by T. John Winhusen, PhD.
- Completed
- Registry status
- Phase 3
- Development phase
- 140
- Enrollment target
- 12
- Study locations
NCT03918850: Completed Phase 3 study of Pregnancy Related and Substance Abuse, sponsored by T. John Winhusen, PhD.
NCT03918850 is a Phase 3 study of Pregnancy Related and Substance Abuse that has completed, run by T. John Winhusen, PhD. The registered enrollment target is 140 participants, below the 1,962-participant average among 99 other Pregnancy Related trials with a reported enrollment target (93% lower). The trial reports 12 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03918850, a Phase 3 study of Pregnancy Related and Substance Abuse, has completed, sponsored by T. John Winhusen, PhD.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 140 participants
- Enrollment target
- 12
- Study locations
Study 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).
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Buprenorphine Injection
- DRUG Buprenorphine Sublingual Product
Study Locations (12)
Massachusetts
- Massachusetts General Hospital HOPE Clinic - Boston
- Boston Medical Center - Boston
Florida
- Gateway Community Services - Jacksonville
New Mexico
- University of New Mexico Milagro Clinic - Albuquerque
Ohio
- University of Cincinnati Health Perinatal Addictions Program - Cincinnati
Oregon
- CODA, Inc. - Portland
Pennsylvania
- Pregnancy Recovery Center at Magee-Womens Hospital of UPMC - Pittsburgh
South Carolina
- Medical University of South Carolina - Charleston
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2020-07-21 |
| Est. Completion | 2025-01-31 |
| Phase | Phase 3 |
What the finished NCT03918850 record still lists
NCT03918850 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 1,962-participant average among 99 other Pregnancy Related trials with a reported enrollment target (93% lower).
The record links to 8 conditions, with Pregnancy Related appearing as the primary indexed condition, and to 2 interventions - of which Buprenorphine Injection is the first listed.
NCT03918850 lists 12 locations in 11 states (Massachusetts, Florida, New Mexico).
Frequently Asked Questions
What is clinical trial NCT03918850 about?
NCT03918850 is a clinical study titled "Medication Treatment for Opioid Use Disorder in Expectant Mothers". 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 h...
What is the current status of trial NCT03918850?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 140 participants. The study started on 2020-07-21. Estimated completion is 2025-01-31.
What conditions does trial NCT03918850 study?
This clinical trial studies the following conditions: Pregnancy Related, Substance Abuse, Opioid-Related Disorders, Drug Abuse, Neonatal Abstinence Syndrome.
What interventions are being tested in trial NCT03918850?
The interventions under investigation include: Buprenorphine Injection (DRUG), Buprenorphine Sublingual Product (DRUG).
Who is sponsoring clinical trial NCT03918850?
This trial is sponsored by T. John Winhusen, PhD, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03918850 being conducted?
This trial has 12 study locations across Florida, Massachusetts, New Mexico, Ohio, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pregnancy Related
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03918850's enrollment target sits among peer trials
140 51st of 99 higher than 48 of 99 other Pregnancy Related trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pregnancy Related trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy (Patch BRIDGE)
RECRUITING · Phase 3
-
Natural Versus Programmed Frozen Embryo Transfer (NatPro)
ACTIVE NOT RECRUITING · Phase 3
-
Early Antenatal Support for Iron Deficiency Anemia
RECRUITING · Phase 4
-
An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis Exposed to Ruxolitinib Cream Versus Topical Corticosteroids During Pregnancy: A US Claims Database Analysis
RECRUITING
-
Mobile Application-based Exercise Intervention for Pregnant Women
RECRUITING · NA
-
Rigorous Evaluation of Yes and Know, a Fully Virtual Sexual Health and Well-Being Intervention for Youth
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01419561 · 140 participants · Phase 2
Natural History Study of the KSHV Inflammatory Cytokine Syndrome (KICS)
- NCT01624805 · 140 participants · Phase 2
Methylprednisolone, Horse Anti-Thymocyte Globulin, Cyclosporine, Filgrastim, and/or Pegfilgrastim or Pegfilgrastim Biosimilar in Treating Patients With Aplastic Anemia or Low or Intermediate-Risk Myelodysplastic Syndrome
- NCT02369770 · 140 participants · NA
Sensory-Motor Rehabilitation Post Stroke
- NCT02455193 · 140 participants · NA
Neuronal Effects of Exercise in Schizophrenia
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI