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NCT06496230 · ClinicalTrials.gov registry record · Early Phase 1
Open Trial of Technology-Enhanced Behavioral Intervention for Buprenorphine Retention in Pregnant and Postpartum People
A Early Phase 1 study of Opioid Use Disorder and Pregnancy Related, sponsored by Medical University of South Carolina.
- Active
- Registry status
- Early Phase 1
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT06496230: Active Early Phase 1 study of Opioid Use Disorder and Pregnancy Related, sponsored by Medical University of South Carolina.
NCT06496230 is a Early Phase 1 study of Opioid Use Disorder and Pregnancy Related that is active but no longer recruiting, run by Medical University of South Carolina. The registered enrollment target is 26 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
NCT06496230, a Early Phase 1 study of Opioid Use Disorder and Pregnancy Related, is active but no longer recruiting, sponsored by Medical University of South Carolina.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study Summary
This study involves testing how useful a technology-enhanced intervention is for pregnant people prescribed buprenorphine for the management of opioid use disorder. The intervention being studied is a brief therapy protocol and a mobile application. Participation involves four 60-minute therapy appointments during pregnancy, and four 30-minute therapy appointments at the end of pregnancy through 3 months postpartum. The mobile application will be accessible for at least the duration of the study. Participants will also be asked to complete questionnaires at enrollment and again at 1-month postpartum and 3-months postpartum, will send monthly photos of their prescription bottle/box, and will be contacted randomly throughout the study to perform a medication count. The total duration of the study is between 5-9 months depending on when you enroll (early second trimester-mid third trimester). Compensation is provided.
Primary Outcome
Feasibility of the intervention (e.g., Recruitment: 20 pregnant women with OUD prescribed buprenorphine; Study retention: ≥50% participants retained through 3-month postpartum assessment; Protocol adherence: ≥50% attend all EMPWR therapy sessions;145 Satisfaction: qualitative feedback to assess what participants liked/did not like about the intervention)
Conditions Studied
Interventions
- BEHAVIORAL Empowering Pregnant Women and People Receiving Medications for Opioid Use Disorder
Study Locations (1)
South Carolina
- Medical University of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2024-08-06 |
| Est. Completion | 2026-01-31 |
| Phase | Early Phase 1 |
What the registry record for NCT06496230 still lists
NCT06496230 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 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 1 intervention - of which Empowering Pregnant Women and People Receiving Medications for Opioid Use Disorder is the first listed.
NCT06496230 reports a single indexed study location in South Carolina.
Frequently Asked Questions
What is clinical trial NCT06496230 about?
NCT06496230 is a clinical study titled "Open Trial of Technology-Enhanced Behavioral Intervention for Buprenorphine Retention in Pregnant and Postpartum People". This study involves testing how useful a technology-enhanced intervention is for pregnant people prescribed buprenorphine for the management of opioid use disorder. The intervention being studied is a brief therapy protocol and a mobile application. Participation involves four 60-minute therapy appo...
What is the current status of trial NCT06496230?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 26 participants. The study started on 2024-08-06. Estimated completion is 2026-01-31.
What conditions does trial NCT06496230 study?
This clinical trial studies the following conditions: Opioid Use Disorder, Pregnancy Related.
What interventions are being tested in trial NCT06496230?
The interventions under investigation include: Empowering Pregnant Women and People Receiving Medications for Opioid Use Disorder (BEHAVIORAL).
Who is sponsoring clinical trial NCT06496230?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06496230 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 NCT06496230's enrollment target sits among peer trials
26 217th of 257 higher than 41 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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