"Cocaine is capable of destroying not only the lives of those addicted, but also those around them," adds Dackis. "An effective treatment for cocaine addiction would help those most vulnerable in our society to overpower their addiction and regain control in their lives." The trial was conducted at Penn's Treatment Research Center between 2002 and 2003. It involved a sample of 62 cocaine-dependent patients (aged 25-63) free of significant medical and psychiatric conditions. All participants were from the Philadelphia area. After initial screenings, eligible patients were randomized to a single morning dose of Modafinil (400 mg), or matching placebo tablets, that was continued for eight weeks along with twice-weekly cognitive behavioral therapy (CBT). Thirty participants were treated with Modafinil; and 32 were given placebo.
The primary efficacy measure was cocaine abstinence, measured by urine toxicity testing. Secondary measures were craving, cocaine withdrawal, retention, and adverse events. Modafinil-treated patients provided significantly more cocaine-negative urine samples over the eight-week period than those given placebo, and were more likely to achieve protracted cocaine abstinence.
Along with this finding, Penn researchers also discovered that there were no serious adverse events in those treated with Modafinil, and none of the patients failed to complete the study as a result of any side effects. "These preliminary results are very promising and three larger studies of modafinil for cocaine dependence are currently underway, including one at Penn," adds Dr. Dackis.
This study was funded by research grants from the National Institute of Drug Abuse. Cephalon Inc. provided Modafinil and matched placebo tablets, but had no participation in the design or implementation of the trial. Other Penn researchers contributing to the study are Kyle M. Kampman, MD, Kevin G. Lynch, PhD, Helen M. Pettinati, PhD, and Charles O'Brien, MD, PhD.
Editor's Notes
Dr. Dackis has received lecture and consultation fees from Cephalon Inc., makers of Modafinil.
You may also find this news release on-line at www.uphs.upenn.edu/news.
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PENN Medicine is a $2.7 billion enterprise dedicated to the related missions of medical education, biomedical research, and high-quality patient care. PENN Medicine consists of the University of Pennsylvania School of Medicine (founded in 1765 as the nation's first medical school) and the University of Pennsylvania Health System (created in 1993 as the nation's first integrated academic health system).
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