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Not yet recruiting NCT07456930

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

Observational Opioid Use Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Opioid Use Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Proportion of attended MOUD medication visits [Time frame: Observation period will be three (3) months.]
  • Proportion of prescribed doses taken [Time frame: Observation period will be three (3) months.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 2 centers
  • SOAP MAT, LLC - Central — San Diego
  • SOAP MAT, LLC - Vista — Vista

Identifiers

NCT: NCT07456930 · MOUDPredict

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗