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 u...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

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)

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Exclusion Criteria

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

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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