CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 125 enrolled
Drug / intervention
uMAT-R mobile app with coaching componentdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06701123
NCT06701123Early Ph 1Completed

mHealth to Help Pregnant and Postpartum Women in Recovery for Opioid Use Disorder

Washington University School of Medicine·interventional·Posted Nov 22, 2024·Updated Apr 3, 2026

In Brief

A Early Phase 1 clinical trial evaluating uMAT-R mobile app with coaching component for Opioid Use Disorders. Completed, enrolled 125 participants across 1 site.

Detailed 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. We will conduct a pilot randomized controlled trial (RCT) among adult PPW with OUD. This RCT is designed to test the feasibility, acceptability, and preliminary efficacy of uMAT-R mobile app versus a control group (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. In addition, local providers who work with pregnant and postpartum people with substance use disorder and/or at a recovery community center will be recruited to provide their feedback. This novel technology could be an invaluable tool to assist physicians in the treatment of OUD among PPW.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Early Ph 1CompletedFinished
202420252026
First PostedNov 22, 2024
Enrollment StartJul 1, 2023
Primary CompletionOct 1, 2024
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 1.6 years ago

Interventions

uMAT-R mobile app with coaching componentdevice

uMAT-R recovery mobile app with coaching component