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NCT03098407 · ClinicalTrials.gov registry record · NA
Opioid Dependence Treatment Therapies in Pregnancy
A NA study of Pregnancy and Opioid-Related Disorders, sponsored by University of Pittsburgh.
- Completed
- Registry status
- NA
- Development phase
- 55
- Enrollment target
- 1
- Study location
NCT03098407: Completed NA study of Pregnancy and Opioid-Related Disorders, sponsored by University of Pittsburgh.
NCT03098407 is a NA study of Pregnancy and Opioid-Related Disorders that has completed, run by University of Pittsburgh. The registered enrollment target is 55 participants, below the 872-participant average among 191 other Pregnancy trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03098407, a NA study of Pregnancy and Opioid-Related Disorders, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- NA
- Development phase
- 55 participants
- Enrollment target
- 1
- Study location
Study Summary
The incidence of opioid dependence in pregnancy increased over the last decade from 1.2 to 5.8 per 1,000 hospital births per year.1 While methadone is the current, standard treatment for opioid dependent (OD) pregnant women, buprenorphine recently emerged as an alternative. In a recent clinical trial (MOTHER), buprenorphine was associated with superior neonatal outcomes such as shorter duration of treatment for neonatal abstinence syndrome (NAS) compared to methadone. However, buprenorphine was also associated with greater study discontinuation (33% vs. 18%) and illicit opioid use (33% vs. 23%) compared to methadone. Treatment dropout often leads to relapse and resumption of high-risk behaviors, overshadowing any short-term improvement in neonatal outcomes. Therefore, The goal of this K23 proposal is to conduct a pilot study to establish the feasibility and acceptability of a randomized comparative effectiveness clinical trial comparing office-based buprenorphine vs. federally licensed methadone programs for the treatment of OD pregnant women. A pilot study is critical to develop the outcome measures, assessment tools and participant tracking techniques necessary for a future, large-scale comparative effectiveness clinical trial. An examination of feasibility and acceptability will also allow use to characterize the subpopulations of OD pregnant women willing to participate in treatment randomization, identify patient and provider characteristics associated with established treatment preferences and inform the development of strategies to improve participation and enhance the generalizability of the future large-scale clinical trial.
Primary Outcome
evaluate a minimum of 9 OD pregnant women per month for possible participation and enrollment, randomize a minimum of 4 participants per month to office-based buprenorphine (PRC) or methadone treatment facility (NATP) for a total of 50 participants over a 12 month enrollment period, retain ≥ 80% of randomized participants until 12 weeks postpartum, and maintain \< 5% of incomplete data.
Conditions Studied
Interventions
- DRUG Methadone
- DRUG Buprenorphine
Study Locations (1)
Pennsylvania
- Magee-Womens Hospital of UPMC - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2017-04-20 |
| Est. Completion | 2020-10-05 |
| Phase | NA |
What the finished NCT03098407 record still lists
NCT03098407 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 872-participant average among 191 other Pregnancy trials with a reported enrollment target (94% lower).
The record links to 2 conditions, with Pregnancy appearing as the primary indexed condition, and to 2 interventions - of which Methadone is the first listed.
NCT03098407 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03098407 about?
NCT03098407 is a clinical study titled "Opioid Dependence Treatment Therapies in Pregnancy". The incidence of opioid dependence in pregnancy increased over the last decade from 1.2 to 5.8 per 1,000 hospital births per year.1 While methadone is the current, standard treatment for opioid dependent (OD) pregnant women, buprenorphine recently emerged as an alternative. In a recent clinical tria...
What is the current status of trial NCT03098407?
This trial is currently completed. It is a NA study. The enrollment target is 55 participants. The study started on 2017-04-20. Estimated completion is 2020-10-05.
What conditions does trial NCT03098407 study?
This clinical trial studies the following conditions: Pregnancy, Opioid-Related Disorders.
What interventions are being tested in trial NCT03098407?
The interventions under investigation include: Methadone (DRUG), Buprenorphine (DRUG).
Who is sponsoring clinical trial NCT03098407?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03098407 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03098407's enrollment target sits among peer trials
55 150th of 191 higher than 41 of 191 other Pregnancy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pregnancy 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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