NCT07456930

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

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
295

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Jun 2026

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

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

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 9, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

March 2, 2026

Last Update Submit

March 16, 2026

Conditions

Keywords

Opioid Use Disorder

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

Study Sites (2)

SOAP MAT, LLC - Central

San Diego, California, 92115, United States

Location

SOAP MAT, LLC - Vista

Vista, California, 92083, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

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

Locations