Double-blind, placebo-controlled trial of selegiline transdermal system (STS) for the treatment of cocaine dependence.
Cocaine dependence is a major public health problem for which there is no FDA-approved pharmacological treatment. Selegiline is an irreversible selective inhibitor of monoamine oxidase type B (MAO-B) which may affect cocaine addiction through several potential mechanisms. In this study, selegiline transdermal system (STS) was compared to placebo as a treatment for cocaine dependence. This multi-site, double-blind trial of 300 subjects with cocaine dependence assessed the efficacy of selegiline using subject self-reported cocaine use substantiated by urine benzoylecgonine (BE) as the primary outcome measure. Analysis of the data did not show a significant effect for selegiline over placebo. This study does not support a role for selegiline in treating cocaine dependence. The contrast of this result to earlier, promising preclinical and human pilot data could be due to factors associated with sample size, patient characteristics, dose, or poor predictive validity of preclinical models.
Elkashef
Ahmed
A
National Institute on Drug Abuse (NIDA), Division of Pharmacotherapies and Medical Consequences of Drug Abuse (DPMCDA), MSC 9551 Bethesda, MD 20892, USA. ae8a@nih.gov
Fudala
Paul J
PJ
Gorgon
Liza
L
Li
Shou-Hua
SH
Kahn
Roberta
R
Chiang
Nora
N
Vocci
Frank
F
Collins
Joseph
J
Jones
Karen
K
Boardman
Kathy
K
Sather
Mike
M
D000279:Administration, Cutaneous; D000328:Adult; D019970:Cocaine-Related Disorders / Q000534:rehabilitation* / Q000652:urine; D004311:Double-Blind Method; D016503:Drug Delivery Systems; D005260:Female; D006801:Humans; D008297:Male; D008996:Monoamine Oxidase Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D012642:Selegiline / Q000008:administration & dosage / Q000627:therapeutic use*
D008996:Monoamine Oxidase Inhibitors; D012642:Selegiline