Penn study may lead the way for first medication to treat cocaine addiction

Breakout data suggests a wake-promoting agent promotes cocaine abstinence


- 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 neuropsychopharmacology. 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, 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 uphs.upenn/news.


About Penn Medcine


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).


Penn's School of Medicine is ranked #3 in the nation for receipt of NIH research funds; and ranked #4 in the nation in U.S.
News & World Report's most recent ranking of top research-oriented medical schools. Supporting 1,400 fulltime faculty and 700
students, the School of Medicine is recognized worldwide for its superior education and training of the next generation of
physician-scientists and leaders of academic medicine.


Penn Health System is comprised of three hospitals ( the Hospital of the University of Pennsylvania, consistently rated one
of the nation's "Honor Roll" hospitals by U.S. News & World Report; Pennsylvania Hospital, the nation's first hospital and
Presbyterian Medical Center); a faculty practice plan; a primary-care provider network; two multispecialty satellite
facilities; and home health care and hospice.


Contact: Ed Federico

ed.federicouphs.upenn

215-349-5659

University of Pennsylvania Medical Center