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NCT06701123 · ClinicalTrials.gov registry record · Early Phase 1
mHealth to Help Pregnant and Postpartum Women in Recovery for Opioid Use Disorder
A Early Phase 1 study of Opioid Use Disorders, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 69
- Enrollment target
- 1
- Study location
NCT06701123: Completed Early Phase 1 study of Opioid Use Disorders, sponsored by Washington University School of Medicine.
NCT06701123 is a Early Phase 1 study of Opioid Use Disorders that has completed, run by Washington University School of Medicine. The registered enrollment target is 69 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (30% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06701123, a Early Phase 1 study of Opioid Use Disorders, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 69 participants
- Enrollment target
- 1
- Study location
Study 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
Primary Outcome
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 so
Conditions Studied
Interventions
- DEVICE uMAT-R mobile app with coaching component
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2023-07-01 |
| Est. Completion | 2024-10-01 |
| Phase | Early Phase 1 |
What the finished NCT06701123 record still lists
NCT06701123 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (30% higher).
The record links to 1 condition, with Opioid Use Disorders appearing as the primary indexed condition, and to 1 intervention - of which uMAT-R mobile app with coaching component is the first listed.
NCT06701123 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT06701123 about?
NCT06701123 is a clinical study titled "mHealth to Help Pregnant and Postpartum Women in Recovery for Opioid Use Disorder". 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 cur...
What is the current status of trial NCT06701123?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 69 participants. The study started on 2023-07-01. Estimated completion is 2024-10-01.
What conditions does trial NCT06701123 study?
This clinical trial studies the following conditions: Opioid Use Disorders.
What interventions are being tested in trial NCT06701123?
The interventions under investigation include: uMAT-R mobile app with coaching component (DEVICE).
Who is sponsoring clinical trial NCT06701123?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06701123 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06701123's enrollment target sits among peer trials
69 355th of 2000 higher than 1,645 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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