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Recruiting

NCT Number: NCT07135323

AvertD Post-Approval Study

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

Recruiting

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Key information

Conditions

Opioid Use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Concentrics Research

Indianapolis, Indiana, 46240, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Opioid Used Disorder Risk Assessment

Genetic

Determine the likelihood of Opioid Used Disorder prior to prescribing opioids

Primary outcomes

  1. Sensitivity and Specificity of AvertD

    Time frame: Measured over 5 years

    Comparison of Averted results to diagnosis of Opioid Used Disorder from M.I.N.I. tool

Study contacts

Contact information is provided by the study sponsor or research team.

Amanda Smith, MD

CONTACT

[email protected]

800-800-5525

Sponsors and collaborators

Lead sponsor

Prescient Medicine Holdings, Inc.

Industry

Collaborators

  • Caron Treatment Centers
  • Concentrics Research

Registry information

Important dates

Study start
2024
Primary completion
2031
Study completion
2031
First posted
Aug 22, 2025
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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