Real-World Evaluation of Compl-AI for Predicting Early Medication Dropout in Opioid Use Disorder Treatment
Real-World Assessment of Compl-AI in Predicting Early Discontinuation of Medication for Treatment of Opioid Use Disorder (MOUD) in Community and Specialty Treatment Programs
1 other identifier
observational
295
1 country
2
Brief Summary
The goal of this observational study is to learn whether the Compl-AI model can accurately predict who is likely to stop their medication for opioid use disorder (MOUD) early in adults receiving real-world treatment for opioid use disorder (OUD). The main questions it aims to answer is: can the model accurately predict early discontinuation of MOUD? Because this study has no comparison groups, all participants receive their usual MOUD as part of routine care. Researchers will observe how participants engage with treatment and how well Compl-AI predicts their outcomes. Participants will complete 4 visits, including a questionnaire about personal experiences during first visit and questions about their substance use and treatment history. During the monthly study visits, the researchers will record in particular the attendance at MOUD medication visits, the medication adherence and any treatment discontinuation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2026
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2026
CompletedFirst Posted
Study publicly available on registry
March 9, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
Study Completion
Last participant's last visit for all outcomes
December 1, 2026
March 18, 2026
March 1, 2026
6 months
March 2, 2026
March 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Proportion of attended MOUD medication visits
Observation period will be three (3) months.
Proportion of prescribed doses taken
Observation period will be three (3) months.
Eligibility Criteria
Adult participants initiating or receiving MOUD in community-based and specialty clinics
You may qualify if:
- Ability to understand and provide written informed consent.
- Male and female participant 18 years of age at the time of consent.
- Participant with OUD based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V).
- Eligible to receive MOUD per site standard of care or currently receiving MOUD initiated prior to study enrollment.
You may not qualify if:
- Cognitive impairment that precludes the ability to provide written informed consent.
- Already enrolled in another study/program.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tools4Patientlead
Study Sites (2)
SOAP MAT, LLC - Central
San Diego, California, 92115, United States
SOAP MAT, LLC - Vista
Vista, California, 92083, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2026
First Posted
March 9, 2026
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
March 18, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share