Recruiting

AvertD

Sponsor:

Prescient Medicine Holdings, Inc.

Code:

NCT07135323

Conditions

Opioid Use Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Opioid Used Disorder Risk Assessment

Study Details

Brief summary:

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

Conditions

Opioid Use Disorder

Study ID

NCT07135323

Start date

Nov 15, 2024

Status verified date

Aug, 2025

Completion date

Nov, 2031

Anticipated

Primary completion date

Nov, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

4000 participants

Anticipated

Interventions and Outcome Measures

Interventions

Opioid Used Disorder Risk Assessment

Determine the likelihood of Opioid Used Disorder prior to prescribing opioids

Primary outcome measure

  • Sensitivity and Specificity of AvertD [ Time Frame: Measured over 5 years ]

Central Contacts and Locations

Central contacts

Amanda Smith, MD

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

Locations

Concentrics Research

Recruiting

Indianapolis, Indiana, United States, 46240

More Information

Sponsor

Prescient Medicine Holdings, Inc.

Last update posted

Aug 22, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Prescient Medicine Holdings, Inc. on 2025-08-22.