Opioid Used Disorder Risk Assessment in Opioid Use Disorder - Clinical Trials Registry

Study Overview

Status

Recruiting

Conditions

Opioid Use Disorder

Intervention / Treatment

Genetic: Opioid Used Disorder Risk Assessment

Study Type

Observational

Enrollment (Estimated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Amanda Smith, MD
Phone Number: 800-800-5525
Email: amanda.smith@concentricsresearch.com

Study Locations

United States
- Indiana
  - Indianapolis, Indiana, United States, 46240
    - Recruiting
    - Concentrics Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Subjects being considered for first oral opioid prescription (4-30 days)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Measured over 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prescient Medicine Holdings, Inc.

Collaborators

Concentrics Research

Caron Treatment Centers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2024

Primary Completion (Estimated)

November 1, 2031

Study Completion (Estimated)

November 1, 2031

Study Registration Dates

First Submitted

July 17, 2025

First Submitted That Met QC Criteria

August 18, 2025

First Posted (Actual)

August 22, 2025

Study Record Updates

Last Update Posted (Actual)