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

March 16, 2026 updated by: Tools4Patient

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

295

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92115
        • SOAP MAT, LLC - Central
        • Contact:
      • Vista, California, United States, 92083
        • SOAP MAT, LLC - Vista
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult participants initiating or receiving MOUD in community-based and specialty clinics

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of attended MOUD medication visits
Time Frame: Observation period will be three (3) months.
Observation period will be three (3) months.
Proportion of prescribed doses taken
Time Frame: Observation period will be three (3) months.
Observation period will be three (3) months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tools4Patient

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 2, 2026

First Submitted That Met QC Criteria

March 2, 2026

First Posted (Actual)

March 9, 2026

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOUDPredict

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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