SOFT - TIAFT 1998 Poster Session 2 Wednesday October 7, 1998
CLINICAL APPLICATION OF THE CEDIA® EDDP (METHADONE METABOLITE) ASSAY (b)

Paul J. Orsulak, Linda C. Akers and Noah Schuyler*

Toxicology Laboratories, VA North Texas Health Care System, Dallas, TX 75216, USA
Roche Diagnostics/Boehringer Mannheim Corporation, Pleasanton, CA 94566, USA

Screening urine samples from patients being treated with methadone is used to evaluate compliance. Because patients taking methadone often produce urine screens which are negative for methadone, we evaluated the clinical use of an assay specific for the methadone metabolite, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP), and compared the results obtained with results from the CEDIA®DAU methadone assay. The cut-off concentrations were 300 ng/mL for the methadone assay and 100 ng/mL for the EDDP assay.

Consecutive patient urine samples (480) submitted for methadone screening were obtained from 106 male subjects (mean age of 48.6 years- range 31-69). The average length of opiate use was 255 months (range 8-516). The average length of methadone treatment was a 165 weeks (range 1-1 361) and the mean daily dosage of methadone was 43 mg per day (range 20-90).

Of the 480 samples, 397 were positive for methadone and EDDP, 45 were positive for EDDP but negative for methadone while 19 specimens were positive for methadone but negative for EDDP. Nineteen urine samples were also negative for both methadone and EDDP. Of most interest in this study were the 45 samples with EDDP levels greater than 1 00 ng/mL but which were negative for methadone. These specimens, representing 9.4% of the samples, are most likely from patients who exhibit either genetically determined or drug induced rapid metabolism of methadone and for whom a methadone screen used alone, would return a false negative and an incorrect clinical conclusion. Longitudinal data on the ability to detect methadone use using both methadone and EDDP assays will be presented.

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