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NCT03911739 · ClinicalTrials.gov registry record
Medication Treatment for Opioid Use Disorder in Expectant Mothers: Infant Neurodevelopmental Outcomes Sub-study
A clinical trial of Pregnancy Related and Substance Abuse, sponsored by T. John Winhusen, PhD.
- Completed
- Registry status
- 71
- Enrollment target
- 10
- Study locations
NCT03911739 is a study of Pregnancy Related and Substance Abuse that has completed, run by T. John Winhusen, PhD. The registered enrollment target is 71 participants, below the 1,962-participant average among 99 other Pregnancy Related trials with a reported enrollment target (96% lower). The trial reports 10 study locations across 9 states.
The verdict
NCT03911739, a study of Pregnancy Related and Substance Abuse, has completed, sponsored by T. John Winhusen, PhD.
- COMPLETED
- Registry status
- 71 participants
- Enrollment target
- 10
- Study locations
Study Summary
This is a sub-study of NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs; Unique protocol ID: 2019-0429-1). Caretakers of the infants delivered by MOMs participants will be offered the opportunity to enroll in this sub-study, which is designed to evaluate the impact of extended-release buprenorphine (BUP-XR), relative to sublingual buprenorphine (BUP-SL), on infant neurodevelopment. The additional data collected in this sub-study will be combined with data from the main MOMs trial.
Conditions Studied
Interventions
- DRUG Buprenorphine Injection
- DRUG Buprenorphine Sublingual Product
Study Locations (10)
Massachusetts
- Massachusetts General Hospital HOPE Clinic - Boston
- Boston Medical Center - Boston
Florida
- Gateway Community Services - Jacksonville
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
Utah
- University of Utah SUPeRAD Clinic - Salt Lake City
Washington
- Addiction Recovery Services (ARS), Swedish Medical Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2021-06-14 |
| Est. Completion | 2024-12-30 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03911739
The ClinicalTrials.gov registry entry for NCT03911739 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 71 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 (96% 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.
NCT03911739 reports 10 study locations spanning 9 distinct geographic areas - top geographies include Massachusetts, Florida, Oregon.
Frequently Asked Questions
What is clinical trial NCT03911739 about?
NCT03911739 is a clinical study titled "Medication Treatment for Opioid Use Disorder in Expectant Mothers: Infant Neurodevelopmental Outcomes Sub-study". This is a sub-study of NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs; Unique protocol ID: 2019-0429-1). Caretakers of the infants delivered by MOMs participants will be offered the opportunity to enroll in this sub-study, which is designed to evaluat...
What is the current status of trial NCT03911739?
This trial is currently completed. The enrollment target is 71 participants. The study started on 2021-06-14. Estimated completion is 2024-12-30.
What conditions does trial NCT03911739 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 NCT03911739?
The interventions under investigation include: Buprenorphine Injection (DRUG), Buprenorphine Sublingual Product (DRUG).
Who is sponsoring clinical trial NCT03911739?
This trial is sponsored by T. John Winhusen, PhD, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03911739 being conducted?
This trial has 10 study locations across Florida, Massachusetts, Oregon, Pennsylvania, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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