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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: Completed study of Pregnancy Related and Substance Abuse, sponsored by T. John Winhusen, PhD.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Bayley Scales of Infant Development is considered the gold standard assessment of early child development and includes cognitive, language, fine motor, and gross motor subscales. Subscale scores each range from 1 - 19, with higher scores indicating higher performance.
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 |
What the finished NCT03911739 record still lists
NCT03911739 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 1,962-participant average among 99 other Pregnancy Related trials with a reported enrollment target (96% 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.
NCT03911739 lists 10 locations in 9 states (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.
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 NCT03911739's enrollment target sits among peer trials
71 63rd of 99 higher than 37 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.
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