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 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.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03918850
The ClinicalTrials.gov registry entry for NCT03918850 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,962-participant average among 99 other Pregnancy Related trials with a reported enrollment target (93% lower). The listed sponsor is T. John Winhusen, PhD, which has 5 total studies on file at ClinicalTrials.gov.
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 reports 12 study locations spanning 11 distinct geographic areas - top geographies include 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.
-
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
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.