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NCT06999811 · ClinicalTrials.gov registry record · NA
Technology-Enhanced Therapy vs. Medication Monitoring for Buprenorphine Retention in Pregnant Persons
A NA study of Opioid Use Disorder and Pregnancy, sponsored by Medical University of South Carolina.
- Recruiting
- Registry status
- NA
- Development phase
- 37
- Enrollment target
- 1
- Study location
NCT06999811: Recruiting NA study of Opioid Use Disorder and Pregnancy, sponsored by Medical University of South Carolina.
NCT06999811 is a NA study of Opioid Use Disorder and Pregnancy that is actively recruiting participants, run by Medical University of South Carolina. The registered enrollment target is 37 participants, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06999811, a NA study of Opioid Use Disorder and Pregnancy, is actively recruiting participants, sponsored by Medical University of South Carolina.
- RECRUITING
- Registry status
- NA
- Development phase
- 37 participants
- Enrollment target
- 1
- Study location
Study Summary
This study involves testing how useful a technology-enhanced therapy is for pregnant people prescribed buprenorphine for the treatment of opioid use disorder, compared to medication monitoring. Participants are randomized to one of the conditions. If participants are randomized to receive the therapy, participants will attend four 60-minute therapy appointments during pregnancy with an additional 30-minute therapy session towards the end of pregnancy, and 6 additional monthly postpartum (after childbirth) sessions (0-6 months postpartum). As part of the therapy program, participants will receive access to a mobile application, which will be accessible for the duration of the study. If participants are randomized to medication monitoring, participants will be asked to log each time participants take their medication for two months. All participants will also be asked to complete questionnaires at enrollment and again at 3-month postpartum and 6-months postpartum, and will be contacted randomly throughout the study to perform a medication count. The total duration of the study is between 8-12 months depending on when participants enroll (early second trimester-mid third trimester).
Primary Outcome
Recruitment will be assessed by the proportion of participants who agree to participate in the trial vs. total approached; success is if ≥70% of approached PPP enroll.
Conditions Studied
Interventions
- BEHAVIORAL Empowering Pregnant Women and People Receiving medications for opioid use disorder (EMPWR)
- OTHER Medication monitoring (control)
Study Locations (1)
South Carolina
- Medical University of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2025-11-05 |
| Est. Completion | 2028-10-15 |
| Phase | NA |
What NCT06999811 shows while recruiting
NCT06999811 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Opioid Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which Empowering Pregnant Women and People Receiving medications for opioid use disorder (EMPWR) is the first listed.
NCT06999811 reports a single indexed study location in South Carolina.
Frequently Asked Questions
What is clinical trial NCT06999811 about?
NCT06999811 is a clinical study titled "Technology-Enhanced Therapy vs. Medication Monitoring for Buprenorphine Retention in Pregnant Persons". This study involves testing how useful a technology-enhanced therapy is for pregnant people prescribed buprenorphine for the treatment of opioid use disorder, compared to medication monitoring. Participants are randomized to one of the conditions. If participants are randomized to receive the therap...
What is the current status of trial NCT06999811?
This trial is currently recruiting. It is a NA study. The enrollment target is 37 participants. The study started on 2025-11-05. Estimated completion is 2028-10-15.
What conditions does trial NCT06999811 study?
This clinical trial studies the following conditions: Opioid Use Disorder, Pregnancy.
What interventions are being tested in trial NCT06999811?
The interventions under investigation include: Empowering Pregnant Women and People Receiving medications for opioid use disorder (EMPWR) (BEHAVIORAL), Medication monitoring (control) (OTHER).
Who is sponsoring clinical trial NCT06999811?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06999811 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06999811's enrollment target sits among peer trials
37 192nd of 257 higher than 66 of 257 other Opioid Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid Use Disorder 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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