Penn Study May Lead the Way for First Medication
to Treat Cocaine Addiction
Breakout Data Suggests a Wake-Promoting Agent Promotes Cocaine Abstinence
(Philadelphia, PA) – Cocaine dependence is a major public health
problem affecting thousands of people around the globe. Despite years
of active research there are still no approved medications for the treatment
of this life-shattering addiction. Researchers are now hopeful that may
soon change based on the results of a controlled study done at the University
of Pennsylvania School of Medicine. The study’s findings
can be found in the January issue of Journal of Neuropsychopharmacology
and on-line at www.neuropsychopharmacology.org.
Penn investigators have identified Modafinil – a wake-promoting
agent approved for the treatment of narcolepsy – as a possible medicinal
treatment for cocaine dependence. In a double-blind, placebo-controlled
trial, researchers found Modafinil promoted cocaine abstinence in treatment-seeking
outpatients. Modafinil was also shown to blunt cocaine-induced euphoria
in a prior study conducted by the same research group, perhaps explaining
its clinical advantage. “If confirmed by further investigation,
this could be the breakthrough we have been waiting for,” says Charles
Dackis, MD, Chief of Psychiatry at the University of Pennsylvania
Medical Center – Presbyterian, and the study’s principal investigator.
“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,
Editor’s Notes: Dr. Dackis has received lecture
and consultation fees from Cephalon Inc., makers of Modafinil.
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
Penn’s School of Medicine is ranked #3 in the nation for receipt
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