Opioid Use DisorderNCT07456930
Real-World Evaluation of Compl-AI for Predicting Early Medication Dropout in Opioid Use Disorder Treatment
An observational study of Opioid Use Disorder, run by Tools4Patient at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- How many people
- 295 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2027to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants initiating or receiving MOUD in community-based and specialty clinics
Who may be able to join
- 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.
Who cannot join
- Cognitive impairment that precludes the ability to provide written informed consent.
- Already enrolled in another study/program.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
SOAP MAT, LLC - Central
San Diego, California, 92115
Laura Rossi, (760) 305-7528, drlaura@soapmat.com
SOAP MAT, LLC - Vista
Vista, California, 92083
Laura Rossi, (760) 305-7528, drlaura@soapmat.com
About this study
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
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:
Read more
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.
- Conditions
- Opioid Use Disorder
- Keywords
- Opioid Use Disorder
- Medical subject headings
- Opioid-Related Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of attended MOUD medication visits
Measured: Observation period will be three (3) months.
Proportion of prescribed doses taken
Measured: Observation period will be three (3) months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start1 Jun 2027 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 295 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tools4Patient
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07456930
- Sponsor's protocol ID
- MOUDPredict
- Status last verified
- Sep 2026
- First submitted
- 2 Mar 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07456930
- Acronym / sponsor ID
- MOUDPredict
- Conditions
- Opioid Use Disorder
- Keywords
- Opioid Use Disorder
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 295 participants (estimated)
- Lead sponsor
- Tools4PatientUniversity, hospital or other
- Study start
- 1 Jun 2027 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants initiating or receiving MOUD in community-based and specialty clinics
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Cognitive impairment that precludes the ability to provide written informed consent.
- Already enrolled in another study/program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Use Disorder, run by Tools4Patient at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chantal Gossuin (+32(0)71140200, chantal.gossuin@cognivia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of attended MOUD medication visits (time frame: Observation period will be three (3) months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.