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The American Journal of Drug and Alcohol Abuse
Encompassing All Addictive Disorders
Volume 34, 2008 - Issue 5
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Original

Clinical Pharmacokinetics of Lofexidine, the α 2-Adrenergic Receptor Agonist, in Opiate Addicts Plasma Using a Highly Sensitive Liquid Chromatography Tandem Mass Spectrometric Analysis

Elmer Yu University of Pennsylvania and Philadelphia Veterans Affairs Medical Center, Philadelphia, Pennsylvania, USA
,
Karen Miotto University of California at Los Angeles and Long Beach Veterans Affairs Medical Center, Los Angeles, California, USA
,
Evaristo Akerele Columbia University College of Physicians and Surgeons and New York State Psychiatric Institute, New York, New York, USA
,
Charles P. O'Brien University of Pennsylvania and Philadelphia Veterans Affairs Medical Center, Philadelphia, Pennsylvania, USA
,
Walter Ling University of California at Los Angeles and Long Beach Veterans Affairs Medical Center, Los Angeles, California, USA
,
Herbert Kleber Columbia University College of Physicians and Surgeons and New York State Psychiatric Institute, New York, New York, USA
,
Marian W. Fischman Columbia University College of Physicians and Surgeons and New York State Psychiatric Institute, New York, New York, USA
,
Ahmed Elkashef Division of Pharmacotherapeutics and Medical Consequences of Drug Abuse (PMC), National Institute on Drug Abuse (NIDA), National Institute of Health (NIH), Bethesda, Maryland, USA
,
Barbara H. Herman Division of Pharmacotherapeutics and Medical Consequences of Drug Abuse (PMC), National Institute on Drug Abuse (NIDA), National Institute of Health (NIH), Bethesda, Maryland, USA
&
Abeer M. Al-Ghananeem Department of Pharmaceutical Sciences, College of Pharmacy, University of Kentucky, Lexington, Kentucky, USA
 show all
Pages 611-616 | Published online: 07 Jul 2009
 
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Abstract

Objectives: The objective of this investigation was to characterize the pharmacokinetic profile of lofexidine. Lofexidine is an orally bioavailable α 2-adrenergic receptor agonist analogue of clonidine that acts centrally to suppress opiate withdrawal symptoms. Methods: During the detoxification period of a phase 3 placebo-controlled, randomized, double-blind trial, six subjects were entered in this preliminary pharmacokinetic study. Results: Pharmacokinetic analysis of plasma samples collected during study day 7 indicated that Cmax was 3242 ± 917 ng/L. The mean trough levels between the study days were not significantly different (p >. 05), suggesting that the subjects were at steady-state. Conclusions: Although preliminary due to the limited number of subjects, these findings are the first to document lofexidine clinical pharmacokinetics in opiate addicts using a highly sensitive liquid chromatography tandem mass spectrometric analysis.

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