Status:
RECRUITING
AvertD Post-Approval Study
Lead Sponsor:
Prescient Medicine Holdings, Inc.
Collaborating Sponsors:
Caron Treatment Centers
Concentrics Research
Conditions:
Opioid Use Disorder
Eligibility:
All Genders
18+ years
Brief Summary
A Prospective Post-Approval Study of AvertD to Evaluate Device Performance, Prescribing Impact, and Labeling Comprehension in the Intended Use Population
Eligibility Criteria
Inclusion
- ≥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
- Planned opioid prescription \<4 or \>30 days
- Any condition making participation unsafe or infeasible per investigator judgment
Key Trial Info
Start Date :
November 15 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2031
Estimated Enrollment :
4000 Patients enrolled
Trial Details
Trial ID
NCT07135323
Start Date
November 15 2024
End Date
November 1 2031
Last Update
August 22 2025
Active Locations (1)
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1
Concentrics Research
Indianapolis, Indiana, United States, 46240