AvertD Post-Approval Study | NCT07135323

Studies
AvertD Post-Approval Study

NCT07135323

Sponsor

Prescient Medicine Holdings, Inc.

Status

Recruiting

Last Update Posted

Aug 22, 2025Actual

Enrollment

4,000Estimated

Phase

Not provided

Conditions

Opioid Use Disorder

Interventions

Opioid Used Disorder Risk Assessment

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 15, 2024Actual

Primary Completion Date

Nov 2031Estimated

Completion Date

Nov 2031Estimated

First Submitted Date

Jul 17, 2025

First Submission Date that Met QC Criteria

Aug 18, 2025

First Posted Date

Aug 22, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 18, 2025

Last Update Posted Date

Aug 22, 2025Actual

Name	Class
Caron Treatment Centers	OTHER
Concentrics Research	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

4,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Opioid Used Disorder Risk Assessment	Genetic	Determine the likelihood of Opioid Used Disorder prior to prescribing opioids

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Amanda Smith, MD	Contact	800-800-5525		amanda.smith@concentricsresearch.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Concentrics Research	Recruiting	Indianapolis	Indiana	46240	United States

Condition Browse Module

MeSH Terms

ID	Term
D009293	Opioid-Related Disorders

Ancestor Terms

ID	Term
D000079524	Narcotic-Related Disorders
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided