Opioid Use Disorder
Conditions
Brief summary
A Prospective Post-Approval Study of AvertD to Evaluate Device Performance, Prescribing Impact, and Labeling Comprehension in the Intended Use Population
Interventions
GENETICOpioid Used Disorder Risk Assessment
Determine the likelihood of Opioid Used Disorder prior to prescribing opioids
Sponsors
Caron Treatment Centers
Concentrics Research
Prescient Medicine Holdings, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and Specificity of AvertD | Measured over 5 years | Comparison of Averted results to diagnosis of Opioid Used Disorder from M.I.N.I. tool |
Countries
United States
Contacts
Primary ContactAmanda Smith, MD
Outcome results
None listed