AvertD Post-Approval Study

Prescient Medicine Holdings, Inc.4,000 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

4,000

Conditions

Opioid Use Disorder

Interventions

Opioid Used Disorder Risk AssessmentGENETIC

Determine the likelihood of Opioid Used Disorder prior to prescribing opioids

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Concentrics Research

Indianapolis, Indiana, United States

RECRUITING

Outcomes

Primary Outcomes

Sensitivity and Specificity of AvertD

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

Time frame: Measured over 5 years

Central Contacts

Amanda Smith, MD

CONTACT

800-800-5525 amanda.smith@concentricsresearch.com

Data from ClinicalTrials.gov

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