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Predicting Oxycodone Dose From Oral Fluid Drug Levels (AFTSLabs)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01928303
Recruitment Status : Completed
First Posted : August 23, 2013
Last Update Posted : September 15, 2014
Sponsor:
Information provided by (Responsible Party):
Neel Mehta, Weill Medical College of Cornell University

Tracking Information
First Submitted Date August 16, 2013
First Posted Date August 23, 2013
Last Update Posted Date September 15, 2014
Study Start Date March 2013
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 19, 2013)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Predicting Oxycodone Dose From Oral Fluid Drug Levels
Official Title Predicting Oxycodone Dose From Oral Fluid Drug Levels For Chronic Pain Management Patients
Brief Summary This study will develop and test an algorithm that will estimate drug dosage from drug levels measured in oral fluid (saliva). Traditionally, urine has been used as the principle medium to monitor drug compliance in patients receiving opioids for chronic pain as well as those being treated for substance abuse. Recently, the use of saliva as an alternative to urine drug testing has been gaining in popularity. Oral fluid has several advantages over urine as a medium for drug screening. In this study, oral fluid, urine and blood specimens will be collected from volunteer patient donors with chronic pain taking opioid medications. Samples from the anonymous donor will be analyzed for opiate class drugs, using New York State Department of Health approved and validated laboratory methods. Analytical results and other information collected will assist in evaluating the use of oral fluid as a specimen to detect opiate drug levels. The measurement of drug concentrations in blood and oral fluid simultaneously will allow for the determination of the amount of oral fluid that will be needed for successful drug testing. It is proposed that by measuring oral fluid drug levels an estimate of the amount of drug taken will be possible.
Detailed Description

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
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Once received into the laboratory at AFTS labs, oral fluid, blood and urine specimens will be aliquoted for analysis, and any remaining sample will be transferred to long term storage at -20 - 0°C.
Sampling Method Non-Probability Sample
Study Population Subjects will be generally healthy males and females who are undergoing treatment for chronic pain.
Condition Chronic Pain
Intervention Not Provided
Study Groups/Cohorts
  • 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.
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 19, 2013)
55
Original Estimated Enrollment Same as current
Actual Study Completion Date August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Adults between 18 and 72 years of age
  • Chronic pain patient at Weill Cornell Medical College Pain Medicine Center

Exclusion Criteria:

  • taking any medications that can alter the metabolism of oxycodone or oxymorphone in the body
  • not a chronic pain patient at Weill Cornell Medical College Pain Medicine Center
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 72 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01928303
Other Study ID Numbers 1212013319
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Neel Mehta, Weill Medical College of Cornell University
Study Sponsor Weill Medical College of Cornell University
Collaborators Not Provided
Investigators Not Provided
PRS Account Weill Medical College of Cornell University
Verification Date September 2014