Clinical trial Recruiting at 1 site Observational Ages 18 and up

AvertD device follow-up for adults starting an oral opioid

Official title: AvertD Post-Approval Study

Run by Prescient Medicine Holdings, Inc. · NCT07135323 · Data updated 2026-11-12

This study will see if using the AvertD risk‑assessment device when adults are first prescribed a short oral opioid course works well, changes prescribing decisions, and helps people understand the device labeling.

More Opioid Use Disorder trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment4000 (estimated)
SponsorPrescient Medicine Holdings, Inc.
Industry-sponsored
Locations1 site (Indianapolis, Indiana)
StatusRecruiting
StartedNovember 15, 2024
Main results expectedNovember 2031
Study endsNovember 2031
Registry record updatedAugust 22, 2025
Trial IDNCT07135323 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18 or older who are being considered for their first oral opioid prescription (planned 4–30 days), are prescribed AvertD as part of care, and can complete yearly follow‑up visits for five years and provide informed consent.

Probably not a fit

People already taking opioids, those with planned opioid prescriptions shorter than 4 days or longer than 30 days, or those judged by the investigator to have conditions making participation unsafe or infeasible may not benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, post‑approval observational follow‑up of the AvertD risk‑assessment device in adults considered for their first oral opioid prescription. Participants are enrolled before their first opioid prescription (planned duration 4–30 days) and receive AvertD as part of routine care. Investigators will collect device performance data, examine whether AvertD alters clinician prescribing, and test how well patients and providers understand the device labeling. Participants complete yearly assessments for up to five years to capture longer‑term outcomes and any safety or usability issues.

Why it matters

Potential benefit: If successful, AvertD could help clinicians identify higher‑risk patients before a first opioid prescription and support safer prescribing and clearer patient guidance.

How similar studies have gone: Published evidence for device‑based opioid risk screening is limited and mixed, so robust post‑approval real‑world data like this are still needed.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* ≥18 years of age
* Prior to first opioid prescription
* Being considered for first oral opioid prescription (4-30 days)
* Prescribed AvertD as part of care
* Willing and able to complete yearly assessments for 5 years
* Signed informed consent

Exclusion Criteria:

* Planned opioid prescription \<4 or \>30 days
* Any condition making participation unsafe or infeasible per investigator judgment

Where it's running

  • Concentrics Research
    Indianapolis, Indiana, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.