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

March 16, 2026 updated by: Washington University School of Medicine
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

125

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Pregnant and Postpartum Participants:

Inclusion Criteria:

  1. Pregnant or up to 3 years postpartum
  2. Receiving treatment consenting treatment facility and/or referred from other participants or community partners
  3. Adult (≥18 years of age)
  4. U.S. resident
  5. OUD or history of opioid misuse
  6. Fluent in English
  7. Own a smartphone with an iOS or Android operating system

Exclusion Criteria:

1) Currently incarcerated

Providers Inclusion Criteria:

  1. Works with pregnant and postpartum people with opioid use disorder and/or at a recovery community center (e.g. a staff person, counselor, social worker, psychiatrist, nurse).
  2. Adult (≥18 years of age)
  3. Fluent in English
  4. Own a smartphone with an iOS or Android operating system

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group- Access to uMAT-R but did not engage
Control Group Access to uMAT-R but did not engage
Experimental: Experimental Group- Mobile App with Coaching Feature
Access to a coached program on uMAT-R App
Device: uMAT-R mobile app with coaching component
uMAT-R recovery mobile app with coaching component

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cravings
Time Frame: Baseline, 1 month
Craving was assessed using the Penn Alcohol Craving Scale (PACS), adapted for opioid craving by replacing alcohol-specific wording with opioid-specific wording. The PACS is a 5-item self-report measure assessing craving over the past week. However, in the current version, we only included 3 items: "(1) How much do you currently crave illicit substances (i.e. opioids, meth, cocaine, MDMAs, etc.)", "(2) In the past week, please rate how strong your desire to use illicit substances has been when something in the environment has reminded you of the illicit substance(s)." and "(3) Please imagine yourself in the environment in which you previous used illicit substances. If you were in this environment today and if it were the time of day that you typically use, what is the likelihood that you would use illicit substances today?" Each item is scored 0 to 10 and summed to a total score ranging from 0 to 30, with higher scores indicating greater craving/worse outcome.
Baseline, 1 month
MOUD Attitudes
Time Frame: Baseline, 1 month
MOUD attitudes were assessed using an adapted 8-item scale originally developed to assess negative attitudes toward methadone (Schwartz et al., 2008) and modified to reference medications for opioid use disorder (e.g., buprenorphine, methadone, naltrexone). Each item was rated on a 5-point scale from 1 to 5. A total score was calculated as the mean of the 8 items, with possible values ranging from 1 to 5. Higher scores indicate more negative attitudes toward MOUD/worse outcome.
Baseline, 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

National Institute on Drug Abuse (NIDA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Actual)

October 1, 2024

Study Completion (Actual)

October 1, 2024

Study Registration Dates

First Submitted

November 20, 2024

First Submitted That Met QC Criteria

November 20, 2024

First Posted (Actual)

November 22, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202102207
  • 5R34DA050453 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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