AvertD Post-Approval Study

Prescient Medicine Holdings, Inc.

Status: Enrolling

Conditions: Opioid Use Disorder

Treatments: Genetic: Opioid Used Disorder Risk Assessment

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07135323

TP-60418

Details and patient eligibility

About

A Prospective Post-Approval Study of AvertD to Evaluate Device Performance, Prescribing Impact, and Labeling Comprehension in the Intended Use Population

Enrollment: 4,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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