Drug Testing and Program Policy

Walla Walla, DC, United States

Drug Testing and Program Policy

Walla Walla, DC, United States
SEARCH FILTERS
Time filter
Source Type

Spinelli E.,Federal University of Fluminense | Barnes A.J.,U.S. National Institute on Drug Abuse | Young S.,U.S. National Institute on Drug Abuse | Castaneto M.S.,U.S. National Institute on Drug Abuse | And 3 more authors.
Drug Testing and Analysis | Year: 2014

Synthetic cannabinoids are marketed as legal alternatives to cannabis, as routine urine cannabinoid immunoassays do not detect synthetic cannabinoids. Laboratories are challenged to identify these new designer drugs that are widely available and represent a major public health and safety problem. Immunoassay testing offers rapid separation of presumptive positive and negative specimens, prior to more costly and time-consuming chromatographic confirmation. The Neogen SPICE ELISA kit targets JWH-018N-pentanoic acid as a marker for urinary synthetic cannabinoids. Assay performance was evaluated by analyzing 2469 authentic urine samples with the Neogen immunoassay and liquid chromatography-tandem mass spectrometry (LC-MS/MS). Two immunoassay cut-off concentrations, 5 and 10μg/L, classified samples as presumptive positive or negative, followed by qualitative LC-MS/MS confirmation for 29 synthetic cannabinoids markers with limits of detection of 0.5-10μg/L to determine the assay's sensitivity, specificity and efficacy. Challenges at ±25% of each cut-off also were investigated to determine performance around the cut-off and intra- and inter-plate imprecision. The immunoassay was linear from 1 to 250μg/L (r2=0.992) with intra- and inter-plate imprecision of ≤5.3% and <9%, respectively. Sensitivity, specificity, and efficiency results with the 5μg/L cut-off were 79.9%, 99.7%, and 97.4% and with the 10μg/L cut-off 69.3%, 99.8%, and 96.3%, respectively. Cross-reactivity was shown for 18 of 73 synthetic cannabinoids markers evaluated. Good sensitivity, specificity, and efficiency, lack of sample preparation requirements, and rapid semi-automation documented that the Neogen SPICE ELISA kit is a viable method for screening synthetic cannabinoids in urine targeting JWH-018N-pentanoic acid. © 2014 John Wiley & Sons, Ltd.


Jeffery D.D.,Center for Healthcare Management Studies | Babeu L.A.,United Road Services | Nelson L.E.,Altarum Institute | Kloc M.,Drug Testing and Program Policy | Klette K.,Center for Healthcare Management Studies
Military Medicine | Year: 2013

Objectives: This study identifies predictors of prescription drug misuse among U.S. active duty service members (ADSM). The 2008 Department of Defense Survey of Health-Related Behaviors (HRB) Among Active Duty Military Personnel indicated that ADSM misuse pain relievers, tranquilizers, sedatives, and stimulants at levels ranging from 2% to 17%. Methods: Secondary, multivariate analyses of HRB survey data examined predictors of self-reported prescription drug misuse for 4 distinct drug categories. Results: Receipt of a pain reliever prescription in the past month, year, or previous year were strong predictors (adjusted odds ratio above 2.0) of misuse for all drug categories; receipt of a prescription for anxiety or depression medication in the past year was the strongest predictor of sedative misuse (adjusted odds ratio = 4.46, 95% confidence intervals 3.18-6.24). Absence of a drug testing program was significantly related to the likelihood of drug misuse for all drug categories. Conclusions: ADSM with a history of treatment for pain and mood disorders, and who self-report headaches, sleep disorders, and fatigue are at higher risk for misusing prescription drugs, perhaps in an effort to self-manage symptoms. The results should be interpreted as a starting place for future exploration, not as the sole basis for policy or program development. © Association of Military Surgeons of the U.S. All rights reserved.


Spinelli E.,U.S. National Institute on Drug Abuse | Spinelli E.,Federal University of Fluminense | Barnes A.J.,U.S. National Institute on Drug Abuse | Young S.,U.S. National Institute on Drug Abuse | And 4 more authors.
Drug Testing and Analysis | Year: 2015

Synthetic cannabinoids are marketed as legal alternatives to cannabis, as routine urine cannabinoid immunoassays do not detect synthetic cannabinoids. Laboratories are challenged to identify these new designer drugs that are widely available and represent a major public health and safety problem. Immunoassay testing offers rapid separation of presumptive positive and negative specimens, prior to more costly and time-consuming chromatographic confirmation. The Neogen SPICE ELISA kit targets JWH-018 N-pentanoic acid as a marker for urinary synthetic cannabinoids. Assay performance was evaluated by analyzing 2469 authentic urine samples with the Neogen immunoassay and liquid chromatography-tandem mass spectrometry (LC-MS/MS). Two immunoassay cut-off concentrations, 5 and 10 μg/L, classified samples as presumptive positive or negative, followed by qualitative LC-MS/MS confirmation for 29 synthetic cannabinoids markers with limits of detection of 0.5-10 μg/L to determine the assay's sensitivity, specificity and efficacy. Challenges at ±25% of each cut-off also were investigated to determine performance around the cut-off and intra- and inter-plate imprecision. The immunoassay was linear from 1 to 250 μg/L (r2=0.992) with intra- and inter-plate imprecision of ≤5.3% and <9%, respectively. Sensitivity, specificity, and efficiency results with the 5 μg/L cut-off were 79.9%, 99.7%, and 97.4% and with the 10 μg/L cut-off 69.3%, 99.8%, and 96.3%, respectively. Cross-reactivity was shown for 18 of 73 synthetic cannabinoids markers evaluated. Good sensitivity, specificity, and efficiency, lack of sample preparation requirements, and rapid semi-automation documented that the Neogen SPICE ELISA kit is a viable method for screening synthetic cannabinoids in urine targeting JWH-018N-pentanoic acid. © 2014 John Wiley & Sons, Ltd.


Wohlfarth A.,U.S. National Institute on Drug Abuse | Scheidweiler K.B.,U.S. National Institute on Drug Abuse | Castaneto M.,U.S. National Institute on Drug Abuse | Castaneto M.,University of Maryland, Baltimore | And 6 more authors.
Clinical Chemistry and Laboratory Medicine | Year: 2015

Background: Identifying synthetic cannabinoid designer drug abuse challenges toxicologists and drug testing programs. The best analytical approach for reliably documenting intake of emerging synthetic cannabinoids is unknown. Primarily metabolites are found in urine, but optimal metabolite targets remain unknown, and definitive identification is complicated by converging metabolic pathways. Methods: We screened 20,017 US military urine specimens collected from service members worldwide for synthetic cannabinoids between July 2011 and June 2012. We confirmed 1432 presumptive positive and 1069 presumptive negative specimens by qualitative liquid chromatography tandem mass spectrometry (LC-MS/MS) analysis including 29 biomarkers for JWH-018, JWH-073, JWH-081, JWH-122, JWH-200, JWH-210, JWH-250, RCS-4, AM2201 and MAM2201. Specimen preparation included enzyme hydrolysis and acetonitrile precipitation prior to LC-MS/MS analysis. We evaluated individual synthetic cannabinoid metabolite detection rates, prevalence, temporal patterns and suitable targets for analytical procedures. Results: Prevalence was 1.4% with 290 confirmed positive specimens, 92% JWH-018, 54% AM2201 and 39% JWH-122 metabolites. JWH-073, JWH-210 and JWH-250 also were identified in 37%, 4% and 8% of specimens, respectively. The United States Army Criminal Investigation Command seizure pattern for synthetic cannabinoid compounds matched our urine specimen results over the time frame of the study. Apart from one exception (AM2201), no parent compounds were observed. Conclusions: Hydroxyalkyl metabolites accounted for most confirmed positive tests, and in many cases, two metabolites were identified, increasing confidence in the results, and improving detection rates. These data also emphasize the need for new designer drug metabolism studies to provide relevant targets for synthetic cannabinoid identification. © 2015 by De Gruyter.


Barnes A.J.,U.S. National Institute on Drug Abuse | Young S.,U.S. National Institute on Drug Abuse | Spinelli E.,U.S. National Institute on Drug Abuse | Spinelli E.,Federal University of Fluminense | And 3 more authors.
Forensic Science International | Year: 2014

Introduction: The recent emergence and widespread availability of many new synthetic cannabinoids support the need for an accurate and high-throughput urine screen for these new designer drugs. We evaluated performance of the immunalysis homogeneous enzyme immunoassay (HEIA) to sensitively, selectively, and rapidly identify urinary synthetic cannabinoids. Methods: 2443 authentic urine samples were analyzed with the HEIA that targets JWH-018 N-pentanoic acid, and a validated LC-MS/MS method for 29 synthetic cannabinoids and metabolites. Semi-quantitative HEIA results were obtained, permitting performance evaluation at and around three cutoffs (5, 10 and 20μg/L), and diagnostic sensitivity, specificity and efficiency determination. Performance challenges at ±25 and ±50% of each cutoff level, cross-reactivity and interferences also were evaluated. Results: Sensitivity, specificity, and efficiency of the immunalysis HEIA K2 Spice kit with the manufacturer's recommended 10μg/L cutoff were 75.6%, 99.6% and 96.8%, respectively, as compared to the reference LC-MS/MS method with limits of detection of 0.1-10μg/L. Performance at 5μg/L was 92.2%, 98.1% and 97.4%, and for the 20μg/L cutoff were 62.9%, 99.7% and 95.4%. Semi-quantitative results for in-house prepared standards were obtained from 2.5-30μg/L, and documented acceptable linearity from 5-25μg/L, with inter-day imprecision <30% (n=17). Thirteen of 74 synthetic cannabinoids evaluated were classified as highly cross-reactive (≥50% at 10μg/L); 4 showed moderate cross-reactivity (10-50% at 10μg/L), 30 low cross-reactivity (<10% at 500μg/L), and 27 <1% cross-reactivity at 500μg/L. There was no interference from 102 investigated compounds. Only a mixture containing 1000μg/L each of buprenorphine/norbuprenorphine produced a positive result above our proposed cutoff (5μg/L) but below the manufacturer's recommended cutoff concentration (10μg/L). Conclusion: The Immunalysis HEIA K2 Spice kit required no sample preparation, had a high-throughput, and acceptable sensitivity, specificity and efficiency, offering a viable method for screening synthetic cannabinoids in urine that cross-react with JWH-018 N-pentanoic acid antibodies. © 2014 Published by Elsevier Ireland Ltd.


Castaneto M.S.,U.S. National Institute on Drug Abuse | Castaneto M.S.,University of Maryland, Baltimore | Desrosiers N.A.,U.S. National Institute on Drug Abuse | Desrosiers N.A.,University of Maryland, Baltimore | And 6 more authors.
Bioanalysis | Year: 2014

Background: Synthetic cannabinoids (SC) are widely-abused cannabimimetic drugs that do not screen positive in traditional cannabinoids immunoassays, making detection difficult. Methods and results: The first commercially-available immunoassay for urinary SC was validated. Limits of detection (5-20 μg/L), imprecision (<13.1% intra-, <37.7% inter-assay), and cross-reactivity profiles of 22 SC and 37 metabolites were obtained. A large negative bias (-80.8 to-28.0%) was observed. Sensitivity (98.3%), specificity (48.1%) and efficiency (53.9%) were determined from screening 20,017 urine specimens and confirming 1432 presumptive positive and 1069 selected negative specimens by LC-MS/MS. Cutoff optimization improved performance to 87.6% sensitivity, 85.2% specificity, and 85.4% efficiency. Conclusion: This high-throughput urine SC assay has good sensitivity and improved specificity and efficiency at modified cutoff concentrations. © 2014 Future Science Ltd.


Castaneto M.S.,U.S. National Institute on Drug Abuse | Castaneto M.S.,University of Maryland, Baltimore | Scheidweiler K.B.,U.S. National Institute on Drug Abuse | Gandhi A.,U.S. National Institute on Drug Abuse | And 5 more authors.
Drug Testing and Analysis | Year: 2015

Synthetic cannabinoid intake is an ongoing health issue worldwide, with new compounds continually emerging, making drug testing complex. Parent synthetic cannabinoids are rarely detected in urine, the most common matrix employed in workplace drug testing. Optimal identification of synthetic cannabinoid markers in authentic urine specimens and correlation of metabolite concentrations and toxicities would improve synthetic cannabinoid result interpretation. We screened 20017 randomly collected US military urine specimens between July 2011 and June 2012 with a synthetic cannabinoid immunoassay yielding 1432 presumptive positive specimens. We analyzed all presumptive positive and 1069 negative specimens with our qualitative synthetic cannabinoid liquid chromatography-tandem mass spectrometry (LC-MS/MS) method, which confirmed 290 positive specimens. All 290 positive and 487 randomly selected negative specimens were quantified with the most comprehensive urine quantitative LC-MS/MS method published to date; 290 specimens confirmed positive for 22 metabolites from 11 parent synthetic cannabinoids. The five most predominant metabolites were JWH-018 pentanoic acid (93%), JWH-N-hydroxypentyl (84%), AM2201 N-hydroxypentyl (69%), JWH-073 butanoic acid (69%), and JWH-122N-hydroxypentyl (45%) with 11.1 (0.1-2,434), 5.1 (0.1-1,239), 2.0 (0.1-321), 1.1 (0.1-48.6), and 1.1 (0.1-250) μg/L median (range) concentrations, respectively. Alkyl hydroxy and carboxy metabolites provided suitable biomarkers for 11 parent synthetic cannabinoids; although hydroxyindoles were also observed. This is by far the largest data set of synthetic cannabinoid metabolites urine concentrations from randomly collected workplace drug testing specimens rather than acute intoxications or driving under the influence of drugs. These data improve the interpretation of synthetic cannabinoid urine test results and suggest suitable urine markers of synthetic cannabinoid intake. This article is a U.S. Government work and is in the public domain in the USA.


Barnes A.J.,U.S. National Institute on Drug Abuse | Spinelli E.,U.S. National Institute on Drug Abuse | Spinelli E.,Federal University of Fluminense | Young S.,U.S. National Institute on Drug Abuse | And 3 more authors.
Therapeutic Drug Monitoring | Year: 2015

Background: Synthetic cannabinoids are touted as legal alternatives to cannabis, at least when first released, and routine urine cannabinoid screening methods do not detect these novel psychoactive substances. Synthetic cannabinoids are widely available, are a major public health and safety problem, and a difficult challenge for drug-testing laboratories. We evaluated performance of the National Medical Services (NMS) JWH-018 direct enzyme-linked immunosorbent assay (ELISA) kit to sensitively, selectively, and rapidly screen urinary synthetic cannabinoids. Methods: The NMS ELISA kit targeting the JWH-018 N-(5-hydroxypentyl) metabolite was used to screen 2492 urine samples with 5 and 10 mcg/L cutoffs. A fully validated liquid chromatography-tandem mass spectrometry method for 29 synthetic cannabinoids markers confirmed all presumptive positive and negative results. Performance challenges at ±25% and ±50% of cutoffs determined intraplate and interplate imprecision around proposed cutoffs. Results: The immunoassay was linear from 1 to 500 mcg/L with intraplate and interplate imprecision of ≤8.2% and <14.0%, respectively. No interferences were present from 93 common drugs of abuse, metabolites, coadministered drugs, over-the-counter medications, or structurally similar compounds, and 19 of 73 individual synthetic cannabinoids (26%) exhibited moderate to high crossreactivity to JWH-018 N-(5-hydroxypentyl) metabolite. Sensitivity, specificity, and efficiency results were 83.7%, 99.4%, and 97.6%, as well as 71.6%, 99.7%, and 96.4% with the 5 and 10 mcg/L urine cutoffs, respectively. Conclusions: This high throughput immunoassay exhibited good diagnostic efficiency and documented that the NMS JWH-018 direct ELISA is a viable method for screening synthetic cannabinoids in urine targeting the JWH-018 N-(5-hydroxypentyl) and related analytes. Optimal performance was achieved with a matrixmatched 5 mcg/L urine cutoff. Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved.


PubMed | U.S. National Institute on Drug Abuse and Drug Testing and Program Policy
Type: Journal Article | Journal: Drug testing and analysis | Year: 2015

Synthetic cannabinoids are marketed as legal alternatives to cannabis, as routine urine cannabinoid immunoassays do not detect synthetic cannabinoids. Laboratories are challenged to identify these new designer drugs that are widely available and represent a major public health and safety problem. Immunoassay testing offers rapid separation of presumptive positive and negative specimens, prior to more costly and time-consuming chromatographic confirmation. The Neogen SPICE ELISA kit targets JWH-018N-pentanoic acid as a marker for urinary synthetic cannabinoids. Assay performance was evaluated by analyzing 2469 authentic urine samples with the Neogen immunoassay and liquid chromatography-tandem mass spectrometry (LC-MS/MS). Two immunoassay cut-off concentrations, 5 and 10g/L, classified samples as presumptive positive or negative, followed by qualitative LC-MS/MS confirmation for 29 synthetic cannabinoids markers with limits of detection of 0.5-10g/L to determine the assays sensitivity, specificity and efficacy. Challenges at 25% of each cut-off also were investigated to determine performance around the cut-off and intra- and inter-plate imprecision. The immunoassay was linear from 1 to 250g/L (r(2) =0.992) with intra- and inter-plate imprecision of 5.3% and <9%, respectively. Sensitivity, specificity, and efficiency results with the 5g/L cut-off were 79.9%, 99.7%, and 97.4% and with the 10g/L cut-off 69.3%, 99.8%, and 96.3%, respectively. Cross-reactivity was shown for 18 of 73 synthetic cannabinoids markers evaluated. Good sensitivity, specificity, and efficiency, lack of sample preparation requirements, and rapid semi-automation documented that the Neogen SPICE ELISA kit is a viable method for screening synthetic cannabinoids in urine targeting JWH-018N-pentanoic acid.


PubMed | U.S. National Institute on Drug Abuse and Drug Testing and Program Policy
Type: Journal Article | Journal: Drug testing and analysis | Year: 2015

Synthetic cannabinoid intake is an ongoing health issue worldwide, with new compounds continually emerging, making drug testing complex. Parent synthetic cannabinoids are rarely detected in urine, the most common matrix employed in workplace drug testing. Optimal identification of synthetic cannabinoid markers in authentic urine specimens and correlation of metabolite concentrations and toxicities would improve synthetic cannabinoid result interpretation. We screened 20017 randomly collected US military urine specimens between July 2011 and June 2012 with a synthetic cannabinoid immunoassay yielding 1432 presumptive positive specimens. We analyzed all presumptive positive and 1069 negative specimens with our qualitative synthetic cannabinoid liquid chromatography-tandem mass spectrometry (LC-MS/MS) method, which confirmed 290 positive specimens. All 290 positive and 487 randomly selected negative specimens were quantified with the most comprehensive urine quantitative LC-MS/MS method published to date; 290 specimens confirmed positive for 22 metabolites from 11 parent synthetic cannabinoids. The five most predominant metabolites were JWH-018 pentanoic acid (93%), JWH-N-hydroxypentyl (84%), AM2201 N-hydroxypentyl (69%), JWH-073 butanoic acid (69%), and JWH-122N-hydroxypentyl (45%) with 11.1 (0.1-2,434), 5.1 (0.1-1,239), 2.0 (0.1-321), 1.1 (0.1-48.6), and 1.1 (0.1-250) g/L median (range) concentrations, respectively. Alkyl hydroxy and carboxy metabolites provided suitable biomarkers for 11 parent synthetic cannabinoids; although hydroxyindoles were also observed. This is by far the largest data set of synthetic cannabinoid metabolites urine concentrations from randomly collected workplace drug testing specimens rather than acute intoxications or driving under the influence of drugs. These data improve the interpretation of synthetic cannabinoid urine test results and suggest suitable urine markers of synthetic cannabinoid intake.

Loading Drug Testing and Program Policy collaborators
Loading Drug Testing and Program Policy collaborators