Urine Toxicology With Pharmacogenomic Interpretation Assay: UTOPIA

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02096172

Acronym

UTOPIA

Enrollment

Registered

2014-03-26

Start date

2014-03-31

Completion date

Unknown

Last updated

2014-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urine Toxicology

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).

Interventions

None listed

Study design

Observational model

COHORT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Outcome results