Real-World Evaluation of Compl-AI for Predicting Early Medication Dropout in Opioid Use Disorder Treatment

NCT07456930 — Not yet recruiting, 295 participants, Tools4Patient

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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

Registry	NCT07456930
Status	Not yet recruiting
Study type	Observational
Enrollment	295 (Estimated)
Sponsor	Tools4Patient (Other)
Conditions	Opioid Use Disorder
Dates	start 2027-06-01 (estimated), primary completion 2027-12-01 (estimated), completion 2027-12-01 (estimated), first posted 2026-03-09, last updated 2026-10-01
Locations	2 sites in United States

-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.

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+Outcome measures

Primary outcomes

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

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Cognitive impairment that precludes the ability to provide written informed consent.
* Already enrolled in another study/program.

+Locations (2)

Facility	City	Country	Status
SOAP MAT, LLC - Central	San Diego, California	United States
SOAP MAT, LLC - Vista	Vista, California	United States