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

Early Phase 1

Completed

• Conditions: Opioid Use Disorders

• Registration Number: NCT06701123
• Lead Sponsor: Washington University School of Medicine

Brief 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 the treatment of OUD among PPW.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-01
• Primary Completion: 2024-10-01
• Study Completion: 2024-10-01
• Status Verified: 2024-11
• Study First Submitted: 2024-11-20
• Study First Submitted QC: 2024-11-20
• Last Update Submitted: 2024-11-20
• Study First Posted: 2024-11-22
• Last Update Posted: 2024-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 69

Inclusion Criteria

1. Pregnant or up to 1 year postpartum
2. Receiving treatment at CARE
3. Adult (≥18 years of age)
4. U.S. resident
5. Currently on MAT
6. Fluent in English
7. women with opioid use disorder (OUD)

Exclusion Criteria

8. Currently incarcerated
9. Patients with acute suicidality or psychotic disorders as assessed by CARE providers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Sobriety	Baseline, 1 month, 2 months, 6 months	DSM 5 criteria for OUD will be assessed using items from the NSDUH that are based on DSM IV criteria and match all but one of the DSM 5 criteria (craving). Craving will be assessed using the Penn Alcohol Craving Scale (PACS) modified for opioid use.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States