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We determined the urinary excretion of MAMP after oral ingestion and examined the effect of using lower cutoffs on detection of exposure. After ingestion, the volunteers collected all urine specimens for 2 weeks. After solid-phase extraction, MAMP and AMP were measured by gas chromatography—positive chemical ionization mass spectrometry with dual silyl derivatization. At the lower cutoff, initial detection times are earlier, detection windows are longer, and confirmation rates are increased. Elimination of the AMP requirement would increase detection rates and allow earlier detection. Worldwide, trafficking of amphetamine-type stimulants increased more than any other drug class during the s, and seizures quadrupled 3. Abuse of the stimulant MAMP is attributable to its potent dopaminergic and sympathomimetic effects, including euphoria, improved cognitive and sensory performance, generalized improvement in mood, increased physical endurance, and appetite suppression 4 5 6 7 8. Negative sequelae are generally attributable to exaggerated central nervous system and cardiovascular effects 4 6 8 9 11 15 16 17 18 19 and include psychosis, paranoia, hyperpyrexia, seizures, stroke, tachycardia, arrhythmias, pericarditis, myocardial ischemia, hypertension, aortic and cerebral aneurysm dissection, and myocardial infarction. MAMP is excreted primarily in urine, with little biliary excretion of the parent drug or metabolites Each unit increase or decrease in urinary pH produces a respective 7-h increase or decrease in the MAMP plasma half-life It has also been reported that the renal clearance of MAMP exceeds that of the average renal filtration rate, suggesting the involvement of an active transport mechanism in the excretion of MAMP AMP requirements were instituted because of the potential for false-positive analytical results with specimens containing other sympathomimetic amines The object of this study was to characterize the urinary excretion of MAMP and its major active metabolite, AMP, in humans after controlled oral administration. Urine concentration data were evaluated to determine detection windows and confirmation rates based on current and proposed confirmation cutoffs and cutoffs based on MAMP requirements alone. Chemicals were obtained from the following sources: Methanol, methylene chloride, 2-propanol, and acetonitrile were HPLC-grade chemicals. All other chemicals were reagent grade. Qualitative and quantitative analyses were performed on a Hewlett-Packard gas chromatograph interfaced with a Hewlett-Packard mass selective detector. The single quadrupole mass spectrometer was operated in positive chemical ionization PCI mode with methane as reactant gas as described previously Participants were healthy volunteers with a history of stimulant and opioid use. Participants were evaluated medically and psychologically before admission to the clinical ward to establish their health. Their vital signs were monitored daily, and routine blood testing CHEM Profile 2 was performed on alternate weeks for medical evaluation throughout the study. Participants were not physically dependent on illicit drugs. During the study, periodic urine specimens were tested to ensure that there was no self-administration of drugs. The first 2 weeks of the study served as a clearance phase for previously self-administered drugs. Morning urine specimens were collected during this time. Drug administrations occurred in weeks 3 and 7. As part of the pharmacodynamic study, participants were administered placebo MAMP capsules in week 6. Participants were scheduled to receive four consecutive daily administrations of the sustained-release formulation, the only form of MAMP available for therapeutic administration at the time of this study. Abbott Laboratories discontinued production of Desoxyn Gradumet in ; the Desoxyn formulation is currently available. If physiologic measures i. However, participants always received four doses once daily within 7 days. We therefore have grouped the data into three categories: The total base equivalent amounts of MAMP administered in the low- and high-dose regimens were Three participants did not receive the high-dose regimen because of personal choice, medical disqualification, or behavioral misconduct. All drug administrations were conducted under subject-blind conditions. Urine specimens were collected ad libitum after initiation of the dosing regimen. Specimens were collected in polypropylene bottles, and void volumes were recorded. Calibrators and controls were prepared in urine that was collected from laboratory volunteers and was demonstrated to be negative for MAMP and AMP by GC-MS analysis before use in the preparation of calibrators and controls. Two dynamic linear ranges were established for the assay. Quantitative analysis was performed by use of split curves at concentration ranges of 2. Specimen samples were analyzed using the curve with the appropriate dynamic range. Calibrators and controls were prepared from different commercially available drug lots and by different analysts. Linear regression analysis of control samples containing 10 and ng of drug were performed using the 2. Calibrators, controls, and specimens were processed by SPE according to a previously published method Briefly, 1 mL of urine was aliquoted, ng of each internal standard was added, and samples were adjusted to acidic pH with 0. Analytes were isolated on preconditioned SPE columns and eluted with methylene chloride—2-propanol—ammonium hydroxide This dual derivatization scheme was originally developed as a method for the analysis of multiple basic drug classes. Urine specimen analyte concentrations were determined in selected ion monitoring mode. The following criteria were used to determine LOQ: The initial detection time after first administration and final detection time after last administration were defined as the first and last specimens positive at or above respective cutoffs. The percentage detection rate was determined by dividing the number of positive specimens collected over a time period by the total number of specimens collected over the same time period and multiplying by Mean detection rates were determined by averaging rates from all participants over a collection period. Total detection rates were also determined by dividing the sum of all positive specimens from all participants by the total number of specimens collected over a collection period. Individual, mean, and total h detection rates were determined after single doses. Ranges and means for final detection times and void number, total urine specimens collected from first drug administration to last positive specimen, total positive specimens from initial dosing to last positive specimen, and total detection rates across participants and doses were also determined. The percentage of MAMP eliminated in urine after each administration regimen was determined by dividing the total amount of MAMP excreted by the total amount of base drug administered in the low- and high-dose regimens Because of postponements that occurred in daily drug administration schedules for several participants, the data were categorized by regimen into three subsets: All single-administration data were collected after low-dose administrations. Administrations were considered single if specimens from five consecutive urine voids collected immediately before the next dosing were negative for both MAMP and AMP at their respective LOQ. Nonconsecutive administrations had random 2- to 4-day intervals between administrations. Peak AMP concentrations after single-administration regimens occurred in the 2nd to 29th void collected at The total amount of AMP excreted ranged from 1. Large intersubject variability in AMP-MAMP ratios were observed, whereas intrasubject ratios after consecutive administration consistently increased over time. This volunteer was the only participant to receive consecutive administrations of the low and high doses, but these patterns were consistent across participants. A correlation between regimen and detection rate was not observed. Final detection times and total detection rates across MAMP doses and administration regimens. The time to last positive from the last drug administration was 22—66 Detection rate also appeared to be correlated with micturition interval. Generally, detection rate increased with longer micturition intervals. Across doses, final detection times were 25—77 Final detection time from last drug administration was 25—77 mean, In three instances, final detection time also increased by 6—10 h. MAMP is abused for its euphoric and performance effects. Reports indicate that truck drivers, construction workers, young professionals, and students commonly self-administer single doses of MAMP to improve performance and to prevent or reverse somnolence However, even low single doses 0. Identification of both habitual and occasional abusers is an important component of medical, workplace, criminal justice, military, and forensic drug testing programs. Therefore, it is important to describe the urinary excretion of MAMP and AMP after controlled administration of single and multiple doses of MAMP and to evaluate the effects of cutoff changes on detection times and rates after these regimens. Results from these studies should help determine interindividual differences in metabolism and excretion of MAMP. Compilation of MAMP excretion data after controlled administration will also provide a scientific database for improved interpretation of urine drug testing and will aid in the development of drug testing policy. MAMP is abused via the smoked, intravenous, and oral routes of administration. It is also a pyrolytic product formed when MAMP is smoked 36 37 This study was part of a larger study on the pharmacokinetics and disposition of MAMP in various biological matrices. However, the impact of confirmation cutoffs on the interpretation of data would be the same with any mass spectrometric method for which adequate sensitivity and specificity have been demonstrated. In a report by Wu et al. The authors did not define the ionization technique used. Using a LOQ of AMP concentrations plateaued by 4—6 h, and contrary to reports after AMP administration 25 , changes in urinary pH had no effect on urinary excretion of the metabolite after this dose. The authors postulated that saturation of AMP excretion mechanisms led to low early urine AMP concentrations that were, in turn, responsible for postponing initial detection times and reducing h detection rates. Low concentrations of MAMP were detected in some specimens collected just before the second drug administration, indicating that MAMP excretion could extend to 7 days after this dose. The urinary excretion pharmacokinetics of MAMP have also been determined and compared after administration of single smoked and intravenous doses to six male volunteers who were experienced MAMP users For two volunteers, there was an initial lag time of 0. Mean peak urine concentrations occurred at 5—20 h determined at the midpoint of each specimen collection interval after both smoking and intravenous administration. Both analytes were still detectable at 60 h. The authors postulated that after a single drug administration to a single participant, a low ratio might be indicative of recent MAMP exposure. However, they recognized that this relationship might not stand for multiple-administration regimens given to a population. These data were also compared with previous urine data collected after controlled subchronic oral MAMP administration. Single doses of oral MAMP-d 3 were administered to eight human volunteers before and after 13 consecutive daily oral administrations of 0. Urinary excretion kinetics did not appear to change after subchronic dosing. Urinary MAMP concentrations peaked in the first 3 h and remained increased through 12—24 h. AMP-d 3 excretion rates were greatest 6—24 h after administration, and urine concentrations peaked during the same time period. Analysis of covariance showed that renal clearance of MAMP-d 3 was dependent on urine pH, renal flow, and dose. In both studies, the fraction of bioavailable MAMP excreted in urine decreased with increasing dose. In the present study, comparison of peak concentrations, total MAMP and AMP excreted, and detection times demonstrated that there was no significant intra- or intersubject dose—urine concentration relationship. Additionally, although there was a trend toward higher MAMP urine concentrations after multiple drug administrations, no administration regimen—concentration relationship could be demonstrated for MAMP or AMP. MAMP reached peak or near-peak concentrations in the first or second void, but peak concentrations of AMP generally occurred later. Consequently, low AMP concentrations were the main cause of low h detection rates. In approximately one-half of the dosing sessions, AMP concentrations exceeded MAMP concentrations in specimens collected late in the excretion phase. However, in the present study, high intra- and intersubject variability in initial and final AMP-MAMP ratios precluded use of a single AMP-MAMP ratio as a measure of chronologic exposure across a population or even within an individual, as also suggested by Cook et al. These data also demonstrate that parent drug-metabolite kinetics become more complicated when a drug is readministered before the total elimination of parent and metabolites, as was the case after both consecutive and nonconsecutive drug administrations. Given the variability in dose and administration regimen of MAMP abusers and the different routes of drug administration, establishing a correlation between analyte ratios and time of MAMP exposure would, therefore, be difficult to make from a single urine AMP-MAMP ratio. In both studies, low h detection rates were attributable almost entirely to failure of specimens to meet the AMP requirement. In the present study, there were relatively large decreases in initial detection times and increases in h detection rates when the AMP requirement was eliminated. Mean initial detection time shifted by 1. Mean final detection time increased from 52 to 64 h. Initial detection times occurred in the first to fourth voids. Detection rates across participants were comparable to rates produced by the 2. Generally, reduction in the MAMP requirement extended both initial and final detection times and increased detection rates. Reduction in the AMP requirement had a more pronounced effect on detection times and rates for specimens collected later than 12 h after initial drug administration. In this study, elimination of AMP requirements produced dramatic improvements in initial detection times and early detection rates. Skip to main content. Research Article Drug Monitoring and Toxicology. Oyler , Edward J. Cone , Robert E. Joseph , Eric T. Moolchan , Marilyn A. Materials and Methods chemicals and reagents Chemicals were obtained from the following sources: View inline View popup. Results excretion pattern, loq detection times and rates, and amp-mamp ratios With the 2. Discussion MAMP is abused for its euphoric and performance effects. Acknowledgments We acknowledge W. Office of Applied Studies. Year-end emergency department data from the Drug Abuse Warning Network. National household survey on drug abuse: United Nations world drug report An analysis of cases of acute high-dose methamphetamine toxicity in Haight-Ashbury. Clin Toxicol ; 3: The treatment of excessive somnolence with stimulant drugs. Sleep ; Derlet RW , Heischober B. West J Med ; The iceman cometh and killeth: Chronopharmacokinetics and chronopharmacodynamics of dextromethamphetamine in man. J Clin Pharmacol ; Caldwell J , Sever PS. The biochemical pharmacology of abused drugs I. Amphetamines, cocaine and LSD. Clin Pharmacol Ther ; Amphetamines and related stimulants: Clinical effects of daily methamphetamine administration. Clin Neuropharmacol ; Long-term behavioral changes in the rhesus monkey after multiple daily injections of delta-methylamphetamine. J Pharmacol Exp Ther ; Chronic d -amphetamine or methamphetamine produces cross-tolerance to the discriminative and reinforcing stimulus effects of cocaine. Clin Toxicol ; 2: Methamphetamine in psychiatric emergencies. Hawaii Med J ; Mechanism of sudden death associated with volatile substance abuse. Hum Toxicol ; 8: Emerg Med Clin North Am ; Cause and manner of death in fatalities involving methamphetamine. J Forensic Sci ; The metabolism of amphetamines in mammals. Drug Metab Rev ; 5: Beckett AH , Rowland M. Urinary excretion of methylamphetamine in man. Nature ; Drug Metab Dispos ; Pharmacokinetics of oral methamphetamine and effects of repeated daily dosing in humans. Disposition of toxic drugs and chemicals in man, 4th ed Urinary excretion kinetics of amphetamine in man. J Pharm Pharmacol ; Substance Abuse and Mental Health Administration. Mandatory guidelines for Federal workplace drug testing programs. Fed Regist ; J Anal Toxicol ; Draft guidelines for federal workplace drug testing program. Cocaine disposition in meconium from newborns of cocaine-abusing mothers and urine of adult drug users. Prolonged occurrence of cocaine in human saliva and urine after chronic use. Sweat testing for cocaine, codeine and metabolites by gas chromatography-mass spectrometry. J Chromatogr ; Separate mechanisms for behavioral, cardiovascular, and hormonal responses to dextroamphetamine in man. Psychopharmacology Berl ; Effects of repeated oral methamphetamine administration in humans. Psychopharmacology ; Pyrolytic characteristics, pharmacokinetics, and bioavailability of smoked heroin, cocaine, phencyclidine, and methamphetamine. Sekine H , Nakahara Y. Abuse of smoking methamphetamine mixed with tobacco: Inhalation efficiencies and pyrolysis products of methamphetamine. Plasma levels of methamphetamine after smoking of methamphetamine hydrochloride. Impact of revised NIDA guidelines for methamphetamine testing in urine. Clin Chem ; Table of Contents Index by author. Clinical Chemistry Oct , 48 10 ;. Show more Drug Monitoring and Toxicology.

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