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A Multisite, Double-blind, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Vigabatrin for Treating Cocaine Dependence

A Multisite, Double-blind, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy... ORIGINAL ARTICLE A Multisite, Double-blind, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Vigabatrin for Treating Cocaine Dependence Eugene C. Somoza, MD, PhD; Douglas Winship, BS; Charles W. Gorodetzky, MD, PhD; Daniel Lewis, BS; Domenic A. Ciraulo, MD; Gantt P. Galloway, PharmD; Scott D. Segal, MD; Michael Sheehan, MD; John D. Roache, PhD; Warren K. Bickel, PhD; Donald Jasinski, MD; Donnie W. Watson, PhD; Steven R. Miller, PhD; Peggy Somoza, MS; Theresa Winhusen, PhD Importance: Cocaine dependence is a significant pub- titative urine drug screens. The weekly fraction of cocaine lic health problem, yet no validated pharmacological treat- use days and the number of drug-free urine samples dur- ment exists. The potent -aminobutyric acid (GABA) ing weeks 1 through 13 were key secondary measures. ergic medication vigabatrin has previously been shown to be effective in a double-blind single-site study con- Results: No significant differences were observed be- ducted in Mexico. tween the vigabatrin group and the placebo group on the primary outcome measure (P=.67), key secondary mea- Objective: To evaluate the safety and efficacy of viga- sures (P.99), or other outcome measures. However, batrin for the treatment of cocaine dependence in a US while pill counts and http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA Psychiatry American Medical Association

A Multisite, Double-blind, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Vigabatrin for Treating Cocaine Dependence

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Publisher
American Medical Association
Copyright
Copyright 2013 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.
ISSN
2168-622X
eISSN
2168-6238
DOI
10.1001/jamapsychiatry.2013.872
pmid
23575810
Publisher site
See Article on Publisher Site

Abstract

ORIGINAL ARTICLE A Multisite, Double-blind, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Vigabatrin for Treating Cocaine Dependence Eugene C. Somoza, MD, PhD; Douglas Winship, BS; Charles W. Gorodetzky, MD, PhD; Daniel Lewis, BS; Domenic A. Ciraulo, MD; Gantt P. Galloway, PharmD; Scott D. Segal, MD; Michael Sheehan, MD; John D. Roache, PhD; Warren K. Bickel, PhD; Donald Jasinski, MD; Donnie W. Watson, PhD; Steven R. Miller, PhD; Peggy Somoza, MS; Theresa Winhusen, PhD Importance: Cocaine dependence is a significant pub- titative urine drug screens. The weekly fraction of cocaine lic health problem, yet no validated pharmacological treat- use days and the number of drug-free urine samples dur- ment exists. The potent -aminobutyric acid (GABA) ing weeks 1 through 13 were key secondary measures. ergic medication vigabatrin has previously been shown to be effective in a double-blind single-site study con- Results: No significant differences were observed be- ducted in Mexico. tween the vigabatrin group and the placebo group on the primary outcome measure (P=.67), key secondary mea- Objective: To evaluate the safety and efficacy of viga- sures (P.99), or other outcome measures. However, batrin for the treatment of cocaine dependence in a US while pill counts and

Journal

JAMA PsychiatryAmerican Medical Association

Published: Jun 1, 2013

References