NCT07135323

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
67mo left

Started Nov 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
Nov 2024Nov 2031

Study Start

First participant enrolled

November 15, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 22, 2025

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2031

Last Updated

August 22, 2025

Status Verified

August 1, 2025

Enrollment Period

7 years

First QC Date

July 17, 2025

Last Update Submit

August 18, 2025

Conditions

Opioid Use Disorder

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and Specificity of AvertD

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

    Measured over 5 years

Interventions

Opioid Used Disorder Risk AssessmentGENETIC

Determine the likelihood of Opioid Used Disorder prior to prescribing opioids

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • ≥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

You may not qualify if:

  • Planned opioid prescription \<4 or \>30 days
  • Any condition making participation unsafe or infeasible per investigator judgment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Concentrics Research

Indianapolis, Indiana, 46240, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Central Study Contacts

Amanda Smith, MD

CONTACT

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2025

First Posted

August 22, 2025

Study Start

November 15, 2024

Primary Completion (Estimated)

November 1, 2031

Study Completion (Estimated)

November 1, 2031

Last Updated

August 22, 2025

Record last verified: 2025-08

Locations

US(1)