Method and device for monitoring medication usage

Abstract

The present invention provides methods for detecting and quantifying metabolites in a biological sample by measuring the concentration of a test metabolite in the sample and comparing that concentration against the concentration of the reference metabolite; enabling accurate metabolite concentration measurements to determine aberrant drug usage patterns. Also disclosed is an analytical testing device and related computer-assisted products for detecting and quantifying metabolites in a biological sample efficiently and accurately.

1 - 9 . (canceled) 
     
     
         10 . A method of quantifying a normalized concentration of a drug in a biological sample, the method comprising:
 (a) providing a biological sample obtained from a subject, wherein the biological sample comprises a test metabolite and a reference metabolite;   (b) determining the presence and concentration of the test metabolite in the biological sample;   (c) determining the concentration of the reference metabolite in the biological sample; and   (d) quantifying the normalized concentration of the drug in the biological sample at least in part as a ratio of the determined concentration of the test metabolite to the determined concentration of the reference metabolite.   
     
     
         11 . The method of  claim 10 , wherein the biological sample is selected from the group consisting of: urine, blood, saliva, sweat, spinal fluid, brain fluid, and combinations thereof. 
     
     
         12 . The method of  claim 10 , wherein the test metabolite is selected from the group consisting of a drug and a drug metabolite. 
     
     
         13 . The method of  claim 10 , wherein the reference metabolite is creatinine. 
     
     
         14 . The method of  claim 10 , wherein the concentration of the test metabolite is determined using an analytical testing device selected from the group consisting of gas chromatography, tandem gas chromatography-mass spectroscopy, and test strips. 
     
     
         15 . The method of  claim 10 , wherein concentration of the reference metabolite is determined by contacting the biological sample with a device capable of distinguishing between the test metabolite and the reference metabolite. 
     
     
         16 . The method of  claim 15 , wherein concentration of the reference metabolite is determined using an analytical testing device selected from the group consisting of: gas chromatography, tandem gas chromatography-mass spectroscopy, and a test strip. 
     
     
         17 . The method of  claim 10 , wherein prior to step (a), the subject has been prescribed a drug therapy regimen, drug dosing therapy, medication regimen, or has been enrolled in a drug treatment program. 
     
     
         18 . A method of quantifying a normalized concentration of a drug in urine, the method comprising:
 providing urine obtained from a subject, wherein the urine comprises a test metabolite and creatinine;   determining the presence and concentration of the test metabolite in the urine;   determining the concentration of the creatinine in the urine; and   quantifying the normalized concentration of the drug in the urine at least in part as a ratio of the determined concentration of the test metabolite to the determined concentration of the creatinine.   
     
     
         19 . The method of  claim 18 , wherein the drug is selected from the group consisting of opioids, stimulants, benzodiazepines, and combinations thereof. 
     
     
         20 . The method of  claim 18 , wherein the drug is selected from the group consisting of oxycodone, morphine, codeine, methadone, fentanyl, propoxyphene, hydrocodone, methylphenidate, dextroamphetamine, diazepam, temazepam, alprazolam, lorazepam, and combinations thereof. 
     
     
         21 . The method of  claim 18 , wherein the test metabolite is selected from the group consisting of a drug, an opioid, a stimulant, a benzodiazepine, oxycodone, morphine, codeine, methadone, fentanyl, propoxyphene, hydrocodone, methylphenidate, dextroamphetamine, diazepam, temazepam, alprazolam, lorazepam, metabolites thereof, and combinations thereof. 
     
     
         22 . The method of  claim 18 , wherein concentration of the reference metabolite is determined by contacting the biological sample with a device capable of distinguishing between the test metabolite and the reference metabolite. 
     
     
         23 . The method of  claim 22 , wherein the concentration of the test metabolite and/or creatinine is determined by gas chromatography, tandem gas chromatography-mass spectroscopy, or a test strip. 
     
     
         24 . A method of quantifying a normalized concentration of a drug in urine, the method comprising:
 obtaining a urine sample from a subject on a prescribed medication regimen, wherein the sample comprises a test metabolite;   contacting the biological sample with an analytical device;   detecting the presence of the test metabolite in the biological sample with the device, wherein the device is capable of measuring the concentration of the test metabolite in the sample;   determining a concentration of creatinine in the urine; and   quantifying the normalized concentration of the drug in the urine-at least in part as a ratio of the determined concentration of the test metabolite to the determined concentration of the creatinine.   
     
     
         25 . The method of  claim 24 , wherein analytical device selected from the group consisting of gas chromatography, tandem gas chromatography-mass spectroscopy, and test strips. 
     
     
         26 . The method of  claim 24 , wherein the drug is selected from the group consisting of opioids, stimulants, benzodiazepines, and combinations thereof. 
     
     
         27 . The method of  claim 26 , wherein the drug is selected from the group consisting of oxycodone, morphine, codeine, methadone, fentanyl, propoxyphene, hydrocodone, methylphenidate, dextroamphetamine, diazepam, temazepam, alprazolam, lorazepam, and combinations thereof. 
     
     
         28 . The method of  claim 24 , wherein the test metabolite is selected from the group consisting of a drug, an opioid, a stimulant, a benzodiazepine, oxycodone, morphine, codeine, methadone, fentanyl, propoxyphene, hydrocodone, methylphenidate, dextroamphetamine, diazepam, temazepam, alprazolam, lorazepam, metabolites thereof, and combinations thereof.