Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
55 participants
OBSERVATIONAL
2013-03-31
2014-08-31
Brief Summary
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Detailed Description
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The donor will produce a sample by placing a collection swab under his or her tongue until the indicator window turns blue. To ensure the validity of the sample, the donor may not eat, drink, or consume candy for ten minutes prior to the collection time.
A second oral fluid sample will be obtained for the purpose of determining salivary pH at the time of collection. The donors will expel oral fluid into a small collection cup or spoon, and the collector will determine pH using specialized pH strips.
Urine samples will be collected from donors in approved specimen cups according to protocols indicated by the New York State Department of Health guidelines. Blood samples will be collected by trained and certified medical professionals using appropriate collection tubes.
Participating donors will also be requested to complete a questionnaire regarding information including age, weight, and medication information (including type of medication, dosage, dosing pattern, and time of last dose), and medical history (concerning known health issues).
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Chronic Pain Patients taking opioid medications
Oral fluid, blood and urine samples will be obtained from chronic pain patients who are taking pain medications from the opioid class of drugs.
No interventions assigned to this group
Negative controls
At least 10% of the total subject population. Chronic pain patients who are not taking pain medication from the opioid class of drugs.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Chronic pain patient at Weill Cornell Medical College Pain Medicine Center
Exclusion Criteria
* not a chronic pain patient at Weill Cornell Medical College Pain Medicine Center
18 Years
72 Years
ALL
No
Sponsors
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Weill Medical College of Cornell University
OTHER
Responsible Party
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Neel Mehta
Assistant Attending of Anesthesiology
Locations
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Weill Cornell Medical College Pain Medicine Center
New York, New York, United States
Countries
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References
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Bush DM. The U.S. Mandatory Guidelines for Federal Workplace Drug Testing Programs: current status and future considerations. Forensic Sci Int. 2008 Jan 30;174(2-3):111-9. doi: 10.1016/j.forsciint.2007.03.008. Epub 2007 Apr 16.
Cone EJ, Clarke J, Tsanaclis L. Prevalence and disposition of drugs of abuse and opioid treatment drugs in oral fluid. J Anal Toxicol. 2007 Oct;31(8):424-33. doi: 10.1093/jat/31.8.424.
Cone EJ, Presley L, Lehrer M, Seiter W, Smith M, Kardos KW, Fritch D, Salamone S, Niedbala RS. Oral fluid testing for drugs of abuse: positive prevalence rates by Intercept immunoassay screening and GC-MS-MS confirmation and suggested cutoff concentrations. J Anal Toxicol. 2002 Nov-Dec;26(8):541-6. doi: 10.1093/jat/26.8.541.
Crouch D, Day J, Baudys J. Evaluation of aliva/oral fluid as an alternate drug testing specimen. NIJ Report 605-04 (2004).
Heit HA, Gourlay DL. Urine drug testing in pain medicine. J Pain Symptom Manage. 2004 Mar;27(3):260-7. doi: 10.1016/j.jpainsymman.2003.07.008.
Hemeryck A, Belpaire FM. Selective serotonin reuptake inhibitors and cytochrome P-450 mediated drug-drug interactions: an update. Curr Drug Metab. 2002 Feb;3(1):13-37. doi: 10.2174/1389200023338017.
Jickells, S and Negrusz, A (editors). (2008) Clarke's Analytical Forensic Toxicology. London: Pharmaceutical Press
Lacy, C, Armstrong, L, Golman, M, and Lance, L (editors). (2011) Drug Information Handbook (20th ed). Hudson, OH: Lexicomp
Speckl IM, Hallbach J, Guder WG, Meyer LV, Zilker T. Opiate detection in saliva and urine--a prospective comparison by gas chromatography-mass spectrometry. J Toxicol Clin Toxicol. 1999;37(4):441-5. doi: 10.1081/clt-100102434.
Other Identifiers
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1212013319
Identifier Type: -
Identifier Source: org_study_id
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