Urinary buprenorphine concentrations in patients treated with suboxone as determined by liquid chromatography-mass spectrometry and CEDIA immunoassay.
We report on the utility of urine total buprenorphine, total norbuprenorphine, and creatinine concentrations in patients treated with Suboxone (a formulation containing buprenorphine and naloxone), used increasingly for the maintenance or detoxification of patients dependent on opiates such as heroin or oxycodone. Patients received 8-24 mg/day buprenorphine. Two-hundred sixteen urine samples from 70 patients were analyzed for both total buprenorphine and total norbuprenorphine by liquid chromatography-mass spectrometry (LC-MS-MS). Buprenorphine concentrations in all 176 samples judged to be unadulterated averaged 164 ng/mL, with a standard deviation (SD) of 198 ng/mL. Nine samples (4.2%) had metabolite-parent drug ratios < 0.02, and 33 (15.3%) had no detectable buprenorphine. The metabolite/parent drug ratio in 166 samples had a range of 0.07-23.0 (mean = 4.52; SD = 3.97). Fifteen of 96 available urine samples (16.7%) had creatinine less than 20 mg/dL. We also found sample adulteration in 7 (7.3%) available samples. Using a 5 ng/mL urine buprenorphine cutoff, the sensitivity and specificity of the Microgenics homogeneous enzyme immunoassay versus LC-MS-MS were 100% and 87.5%, respectively. The 5 ng/mL cutoff Microgenics CEDIA buprenorphine assay results agreed analytically with LC-MS-MS in 97.9% of samples.
Hull
Mindy J
MJ
Department of Pathology, Massachusetts General Hospital and Harvard Medical School, 55 Fruit Street, Boston, Massachusetts 02114, USA.
Bierer
Michael F
MF
Griggs
David A
DA
Long
William H
WH
Nixon
Andrea L
AL
Flood
James G
JG
D000328:Adult; D002047:Buprenorphine / Q000493:pharmacokinetics*; D000069479:Buprenorphine, Naloxone Drug Combination; D002138:Calibration; D002851:Chromatography, High Pressure Liquid; D003404:Creatinine / Q000652:urine; D004338:Drug Combinations; D005260:Female; D006801:Humans; D007118:Immunoassay; D008297:Male; D013058:Mass Spectrometry; D009270:Naloxone / Q000493:pharmacokinetics* / Q000652:urine; D009292:Narcotic Antagonists / Q000652:urine; D010349:Patient Compliance; D015203:Reproducibility of Results
D000069479:Buprenorphine, Naloxone Drug Combination; D004338:Drug Combinations; D009292:Narcotic Antagonists; D009270:Naloxone; D002047:Buprenorphine; D003404:Creatinine