Predicting Oxycodone Dose From Oral Fluid Drug Levels (AFTSLabs)
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|ClinicalTrials.gov Identifier: NCT01928303|
Recruitment Status : Completed
First Posted : August 23, 2013
Last Update Posted : September 15, 2014
|Condition or disease|
Each potential subject will be requested to verify their willingness to participate in the study by signing and dating an Informed Consent Form and the Health Insurance Portability and Accountability Act (HIPAA) Authorization for use of protected health information in research.
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).
|Study Type :||Observational|
|Actual Enrollment :||55 participants|
|Official Title:||Predicting Oxycodone Dose From Oral Fluid Drug Levels For Chronic Pain Management Patients|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
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.
At least 10% of the total subject population. Chronic pain patients who are not taking pain medication from the opioid class of drugs.
- original dose of drug consumed (mg) as predicted by the drug concentration in the oral fluid (ng/mL) [ Time Frame: subjects will be followed for 6 months after enrollment. ]The primary goal of the study is to develop and test an algorithm that will estimate drug dosage from measured oral fluid drug levels.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01928303
|United States, New York|
|Weill Cornell Medical College Pain Medicine Center|
|New York, New York, United States, 10065|