Standard of Care Versus Urine Testing With Selective PHarmacogenomics for Effective Drug and Dosing REgimens

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the addition of selective pharmacogenomic (PGx) testing as determined by Urine Drug Testing (UDT) adds a clinical benefit as evidenced by a reduction in Target Drug-related Adverse Events (TDRAE) over the period following enrollment.

Official Title
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Standard of Care Versus Urine Testing With Selective PHarmacogenomics for Effective Drug and Dosing REgimens: SPHERE

Conditions
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Target Drug-related Adverse Events

Intervention / Treatment
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* Other: Urine diagnostic testing as SOC, drug regimen changes per SOC
* Other: Urine diagnostic testing with selective PGx testing, drug regimen changes based on PGx test results


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is 12 years of age or older; Subject or legal representative is able and willing to provide informed consent; Subject has had a TDRAE including ineffective therapeutic response within the last 60 days or is a new patient to the treating healthcare provider's practice; Subject is scheduled for or is planned to be scheduled for UDT, ordered as per the treating healthcare provider's local standard of care; Subject is currently receiving or the subject's treating healthcare provider is considering treatment with at least one target drug listed below and metabolized by one or more genes considered in this study: Amitriptyline, Imipramine, Diazepam, Alprazolam, Codeine, Hydrocodone, Oxycodone, Methadone, Meperidine, Fentanyl and Carisoprodol. Exclusion Criteria: Prior history of PGx testing for genes specific to any of the target drugs in the past; PGx testing is deemed mandatory in the opinion of the treating healthcare provider; History of liver or renal transplantation; Receiving chronic hemodialysis or peritoneal dialysis; Currently hospitalized or in a long-term care facility; Participation in another clinical trial that would, in the Investigator's opinion, interfere with the conduct of this study; Subject or subject's guardian or advocate is unable to provide an accurate history of the subject's medical history, medications, and symptoms.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard of Care (SOC Arm)<br>Standard of Care UDT | Other: Urine diagnostic testing as SOC, drug regimen changes per SOC<br> <br> |
| Other: Selective PGx Testing (Test Arm)<br>Standard of Care UDT with selective PGx testing | Other: Urine diagnostic testing with selective PGx testing, drug regimen changes based on PGx test results<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects who experience target drug-related adverse events (TDRAE) over the 90-day period following enrollment |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All TDRAE as quantified within each of the four classes of medications |  | 90 days | 
| TDRAE driving a change in the subject's drug regimen (dose change, discontinuation, substation, or addition of a new drug) |  | 90 days | 
| Severe TDRAE, defined as a TDRAE that meets the criteria for a Serious Adverse Event |  | 90 days | 
| Ineffective therapeutic response, determined by the Investigator |  | 90 days | 
| Supra-therapeutic response, as determined by the Investigator |  | 90 days | 
| Frequency of subjects with changes in drug regimen |  | 90 days | 
| Healthcare resource utilization, as measured by the number of outpatient clinic visits, emergency room/urgent care visits, and hospitalizations; tabulated over the 90-day period following enrollment |  | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacogenomics, Urine Drug Testing, antidepressants, benzodiazepines, opioids, muscle relaxants, non-steroidal anti-inflammatory agents, TDRAE