NCT07135323RecruitingAccepts Healthy Volunteers
AvertD Post-Approval Study
Prescient Medicine Holdings, Inc.
Start Date
11/15/2024
Completion Date
11/1/2031
Summary
A Prospective Post-Approval Study of AvertD to Evaluate Device Performance, Prescribing Impact, and Labeling Comprehension in the Intended Use Population
Eligibility Criteria
Age Range: 18 years to No maximum
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
Interventions
GENETIC
Opioid Used Disorder Risk Assessment
Conditions
Opioid Use Disorder
Locations
Concentrics Research
Indianapolis, Indiana 46240
United States