AvertD Post-Approval Study

NCT ID: NCT07135323

Last Updated: 2025-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-15

Study Completion Date

2031-11-30

Brief Summary

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

Detailed Description

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Conditions

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Opioid Use Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Opioid Used Disorder Risk Assessment

Determine the likelihood of Opioid Used Disorder prior to prescribing opioids

Intervention Type GENETIC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Caron Treatment Centers

OTHER

Sponsor Role collaborator

Concentrics Research

OTHER

Sponsor Role collaborator

Prescient Medicine Holdings, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Concentrics Research

Indianapolis, Indiana, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Amanda Smith, MD

Role: CONTACT

800-800-5525

Other Identifiers

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TP-60418

Identifier Type: -

Identifier Source: org_study_id

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