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Early Phase 1 N=125 Treatment

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

Opioid Use Disorders

Enrolled (actual)
125
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Cravings — 11.90; 8.94; 11.10; 8.21 score on a scale (total score, 0 to 30) — p=0.12

Study Design & Population

Study type
Interventional
Phase
Early Phase 1
Interventions
uMAT-R mobile app with coaching component (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
Washington University School of Medicine
Primary completion
Oct 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Cravings
11.90; 8.94; 11.10; 8.21 0.12
PRIMARY
MOUD Attitudes
3.52; 3.35; 3.11; 2.92 0.51

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.

Eligibility Criteria

Pregnant and Postpartum Participants:

Inclusion Criteria

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

Exclusion Criteria

  • Currently incarcerated

Providers Inclusion Criteria:

  • 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).
  • Adult (≥18 years of age)
  • Fluent in English
  • Own a smartphone with an iOS or Android operating system
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06701123). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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