Urine Toxicology With Pharmacogenomic Interpretation Assay: UTOPIA (UTOPIA)

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).

Study Overview

• Status: Withdrawn
• Conditions: Urine Toxicology

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Male and female subjects who are considered candidates for UDT.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Influence of CYP450 drug metabolism on quantitative UDT	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.	24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Occurrence of illicit drugs detected on UDT and the GEM classification associated with these medications	24 months
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
Frequency of target drug regimen changes by the treating physician due to pharmacogenomic test results	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

Collaborators and Investigators

• Sponsor: Renaissance RX
• Collaborators: Syntactx

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: March 21, 2014
• First Submitted That Met QC Criteria: March 21, 2014
• First Posted (Estimate): March 26, 2014

Study Record Updates

• Last Update Posted (Estimate): September 23, 2014
• Last Update Submitted That Met QC Criteria: September 22, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 2013-002