Urine Toxicology With Pharmacogenomic Interpretation Assay: UTOPIA

Withdrawn

• Conditions: Urine Toxicology

• Registration Number: NCT02096172
• Lead Sponsor: Renaissance RX

Brief Summary

The objective of this study is to evaluate the impact of pharmacogenomic aspects of drug metabolism on the measurement of drug and drug metabolites on urine drug testing (UDT).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-21
• Study First Submitted QC: 2014-03-21
• Study First Posted: 2014-03-26
• Primary Completion: 2014-07
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-22
• Last Update Posted: 2014-09-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Able to provide written informed consent
• Pharmacogenomic testing within the last 60 days
• Planned UDT

Exclusion Criteria

• Subject has chronic renal dysfunction, Chronic Kidney Disease Stage 4 or 5
• Subject has a history of abnormal hepatic function within the last 2 years (INR >1.2 not attributable to anticoagulant medications, AST or ALT >1.5x normal, or suspected cirrhosis)
• Subject has a history of malabsorption (short gut syndrome);
• Subject has a history of any gastric or small bowel surgery;
• Subject is currently hospitalized;
• Subject is currently receiving intravenous medication.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Influence of CYP450 drug metabolism on quantitative UDT	24 months	Occurrence of genetically-determined abnormal metabolism of drugs tested with UDT, classified as genetic effects on metabolism (GEM) + for rapid metabolizers, GEM 0 for normal metabolizers, and GEM - for slow metabolizers.

Secondary Outcome Measures

Name	Time	Method
Non-prescribed drugs detected on UDT and the GEM classification associated with these medications	24 months
Occurrence of illicit drugs detected on UDT and the GEM classification associated with these medications	24 months
Frequency of target drug regimen changes by the treating physician due to pharmacogenomic test results	24 months
False positive immunoassay results, defined as positive immunoassay concurrent with negative quantitative testing	24 months
Frequency of illicit drug changes by the subject due to UDT results, as observed at the time of repeat UDT	24 months
Frequency of non-prescribed drug changes by the subject due to UDT results, as detected at the time of repeat UDT	24 months