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Published:
Journal of Analytical Toxicology,
ISSN 0146-4760,
Volume 32, Number 7, September,
pp.516-521
Urinary Buprenorphine
Concentrations in Patients Treated with Suboxone® as Determined
by Liquid Chromatography–Mass Spectrometry and CEDIA Immunoassay
Mindy J. Hull1, Michael F. Bierer2, David A. Griggs1, William
H. Long1, Andrea L. Nixon1, and James G. Flood1,
Departments of 1Pathology and
2Medicine, Massachusetts General
Hospital and Harvard Medical School, 55 Fruit Street, Boston, Massachusetts
02114
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.
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