AvertD device follow-up for adults starting an oral opioid
AvertD Post-Approval Study
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 |
|---|---|
| Enrollment | 4000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Prescient Medicine Holdings, Inc. Industry-sponsored |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT07135323 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Published evidence for device‑based opioid risk screening is limited and mixed, so robust post‑approval real‑world data like this are still needed.
Eligibility criteria
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 this trial is running
Indianapolis, Indiana
- Concentrics Research — Indianapolis, Indiana, United States (Recruiting)
Study contacts
- Study coordinator: Amanda Smith, MD
- Email: amanda.smith@concentricsresearch.com
- Phone: 800-800-5525
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.