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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTools4Patient

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Cognitive impairment that precludes the ability to provide written informed consent.

Already enrolled in another study/program.

Trial population

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

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Proportion of attended MOUD medication visits

Time frame
Observation period will be three (3) months.
2

Proportion of prescribed doses taken

Time frame
Observation period will be three (3) months.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: