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NCT03911466 · ClinicalTrials.gov registry record
Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments Sub-study
A clinical trial of Pregnancy Related and Substance Abuse, sponsored by T. John Winhusen, PhD.
- Completed
- Registry status
- 97
- Enrollment target
- 12
- Study locations
NCT03911466: Completed study of Pregnancy Related and Substance Abuse, sponsored by T. John Winhusen, PhD.
NCT03911466 is a study of Pregnancy Related and Substance Abuse that has completed, run by T. John Winhusen, PhD. The registered enrollment target is 97 participants, below the 1,962-participant average among 99 other Pregnancy Related trials with a reported enrollment target (95% lower). The trial reports 12 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03911466, a study of Pregnancy Related and Substance Abuse, has completed, sponsored by T. John Winhusen, PhD.
- COMPLETED
- Registry status
- 97 participants
- Enrollment target
- 12
- 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). Participants in MOMs will be offered the opportunity to enroll in this sub-study, which is designed to evaluate conceptual models of the mechanisms by which extended-release buprenorphine (BUP-XR), may improve mother-infant outcomes, compared to sublingual buprenorphine (BUP-SL). The additional data collected in this sub-study will be combined with data from the main MOMs trial. It is hypothesized that: (1) the buprenorphine blood levels will vary, depending on which formulation of buprenorphine was received, (2) the variation in buprenorphine blood levels will be associated with fetal behavior (including fetal heart rate variability) (3) the variation in buprenorphine blood levels will be associated with differences in mother outcomes (including medication adherence and illicit opioid use) (4) the variation in buprenorphine blood levels and in fetal behavior will be associated with infant outcomes (including neonatal opioid withdrawal syndrome and infant development).
Primary Outcome
A blood draw at the estimated time of minimum drug concentration ("trough") to evaluate adequacy of dose for the conceptual model.
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 | 97 participants |
| Start Date | 2020-07-21 |
| Est. Completion | 2024-11-06 |
What the finished NCT03911466 record still lists
NCT03911466 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 97 participants, a relatively small participant target, below the 1,962-participant average among 99 other Pregnancy Related trials with a reported enrollment target (95% 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.
NCT03911466 lists 12 locations in 11 states (Massachusetts, Florida, New Mexico).
Frequently Asked Questions
What is clinical trial NCT03911466 about?
NCT03911466 is a clinical study titled "Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments 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). Participants in MOMs will be offered the opportunity to enroll in this sub-study, which is designed to evaluate conceptual models of the mechanism...
What is the current status of trial NCT03911466?
This trial is currently completed. The enrollment target is 97 participants. The study started on 2020-07-21. Estimated completion is 2024-11-06.
What conditions does trial NCT03911466 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 NCT03911466?
The interventions under investigation include: Buprenorphine Injection (DRUG), Buprenorphine Sublingual Product (DRUG).
Who is sponsoring clinical trial NCT03911466?
This trial is sponsored by T. John Winhusen, PhD, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03911466 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
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Where NCT03911466's enrollment target sits among peer trials
97 58th of 99 higher than 42 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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