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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 4000 (estimated) |
| Sponsor | Prescient Medicine Holdings, Inc. Industry-sponsored |
| Locations | 1 site (Indianapolis, Indiana) |
| Status | Recruiting |
| Started | November 15, 2024 |
| Main results expected | November 2031 |
| Study ends | November 2031 |
| Registry record updated | August 22, 2025 |
| Trial ID | NCT07135323 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
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Concentrics Research
Indianapolis, Indiana, United States Recruiting
Study contacts
- Study coordinator: Amanda Smith, MD
- Email: amanda.smith@concentricsresearch.com
- Phone: 800-800-5525
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.