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mHealth to Help Pregnant and Postpartum Women in Recovery for Opioid Use Disorder
NCT06701123 · View on ClinicalTrials.gov ↗
Study Summary
The opioid epidemic has resulted in widespread detrimental consequences among vulnerable populations in Missouri, especially among pregnant and postpartum women (PPW) with opioid use disorder (OUD). Perinatal use of medication-assisted treatment (MAT) within a comprehensive treatment plan is the current standard of care, however PPW struggling with OUD may underestimate or misjudge its benefits. At the same time, emerging findings signal that mobile health (mHealth) technologies have the potential to support healthier behaviors among individuals with OUD. In this project, we will test the utility of a theoretically-based digital therapeutics tool (uMAT-R) to encourage MAT adherence and treatment retention while considering the unique needs of PPW. In Aim #1, we will conduct four focus groups with PPW with OUD (target users) on the intervention components of uMAT-R, gathering feedback on theory-driven components that are candidates for inclusion in the tool and eliciting suggestions for additional intervention components. In Aim #2, the tool will be beta-tested for technical/navigational issues among 20 participants. In Aim #3, we will conduct a pilot randomized controlled trial (RCT) among adult PPW with OUD (n=60). This RCT is designed to test the feasibility, acceptability, and preliminary efficacy of uMAT-R (n=40) versus a control group (n=20 who receive treatment-as-usual) regarding participants' treatment adherence, sobriety, and improved MAT attitudes, norms, and perceived control. Recruitment for all Aims will occur at a clinic in St. Louis, Missouri that provides perinatal medication-assisted treatment (MAT) and high-risk maternity care to PPW struggling with OUD. Clinically meaningful effect size and attrition estimates will aid in the planning of a larger RCT in which we will test uMAT-R on a larger scale and expand our recruitment to other clinics across Missouri and other states. This novel technology could be an invaluable tool to assist physicians in
Conditions Studied
Interventions
- DEVICE uMAT-R mobile app with coaching component
Study Locations (1)
Missouri
- Washington University School of Medicine — St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2023-07-01 |
| Est. Completion | 2024-10-01 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06701123
The ClinicalTrials.gov registry entry for NCT06701123 describes a study currently listed as completed. It is categorized as Early Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,036 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Opioid Use Disorders appearing as the primary indexed condition, and to 1 intervention — of which uMAT-R mobile app with coaching component is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06701123 reports 1 study location spanning 1 distinct geographic area — top geographies include Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06701123 about?
NCT06701123 is a clinical study titled "mHealth to Help Pregnant and Postpartum Women in Recovery for Opioid Use Disorder". The opioid epidemic has resulted in widespread detrimental consequences among vulnerable populations in Missouri, especially among pregnant and postpartum women (PPW) with opioid use disorder (OUD). Perinatal use of medication-assisted treatment (MAT) within a comprehensive treatment plan is the cur...
What is the current status of trial NCT06701123?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 69 participants. The study started on 2023-07-01. Estimated completion is 2024-10-01.
What conditions does trial NCT06701123 study?
This clinical trial studies the following conditions: Opioid Use Disorders. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06701123?
The interventions under investigation include: uMAT-R mobile app with coaching component (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06701123?
This trial is sponsored by Washington University School of Medicine, which has 1,036 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06701123 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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