NCT01052155

Brief Summary

Accuracy of Point of Care (POC) or In-office Urine Drug Testing (Immunoassay) in Chronic Pain Patients: A Prospective Analysis of Immunoassay and Liquid Chromatography Tandem Mass Spectometry (LC/MS/MS)

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2010

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 20, 2010

Completed
12 days until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

March 14, 2011

Status Verified

March 1, 2011

Enrollment Period

4 months

First QC Date

January 18, 2010

Last Update Submit

March 11, 2011

Conditions

Chronic Pain

Keywords

Controlled substancesOpioidsBenzodiazepinesIllicit drugsImmunoassay drug testingPoint of care (POC) testingLiquid Chromatography Tandem Mass Spectometry

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy

    72 hours

Interventions

Urine Drug TestingOTHER

LC/MS/MS Laboratory Evaluation

Also known as: In-office Urine Drug Testing (Immunoassay)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with chronic pain management with or without controlled substance therapy.

You may qualify if:

  • Chronic pain management with or without controlled substance therapy.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Manchikanti L, Malla Y, Wargo BW, Fellows B. Comparative evaluation of the accuracy of benzodiazepine testing in chronic pain patients utilizing immunoassay with liquid chromatography tandem mass spectrometry (LC/MS/MS) of urine drug testing. Pain Physician. 2011 May-Jun;14(3):259-70.

    PMID: 21587329DERIVED

  • Manchikanti L, Malla Y, Wargo BW, Fellows B. Comparative evaluation of the accuracy of immunoassay with liquid chromatography tandem mass spectrometry (LC/MS/MS) of urine drug testing (UDT) opioids and illicit drugs in chronic pain patients. Pain Physician. 2011 Mar-Apr;14(2):175-87.

    PMID: 21412372DERIVED

  • Manchikanti L, Malla Y, Wargo BW, Cash KA, Pampati V, Damron KS, McManus CD, Brandon DE. Protocol for accuracy of point of care (POC) or in-office urine drug testing (immunoassay) in chronic pain patients: a prospective analysis of immunoassay and liquid chromatography tandem mass spectometry (LC/MS/MS). Pain Physician. 2010 Jan-Feb;13(1):E1-E22.

    PMID: 20119473DERIVED

MeSH Terms

Conditions

Chronic PainSubstance-Related Disorders

Interventions

Immunoassay

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Immunologic TechniquesInvestigative TechniquesMolecular Probe Techniques

Study Officials

  • Laxmaiah Manchikanti, MD

    Ambulatory Surgery Center, Paducah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 18, 2010

First Posted

January 20, 2010

Study Start

February 1, 2010

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

March 14, 2011

Record last verified: 2011-03