Modafinil Combined With Cognitive Behavior Therapy to Treat Cocaine Addiction - 1

The development of a medication to treat cocaine addiction specifically by lessening
withdrawal symptoms has been a primary focus of research. Common cocaine withdrawal symptoms
include depression, lack of energy, and poor concentration. Modafinil, a central nervous
system stimulant, is a medication that can speed up physical and mental processes in the
brain. It is currently used to treat narcolepsy, a condition that causes excessive
sleepiness. Modafinil enhances mood, increases energy, and improves concentration in people
with narcolepsy. Modafinil may also cause the same effects in individuals addicted to
cocaine, thereby countering the symptoms of cocaine withdrawal. The purpose of this study is
to compare the effectiveness of modafinil plus CBT versus placebo plus CBT for treating
cocaine dependence.

A 2-week screening period will be followed by an 8-week treatment phase. Participants will
be randomly assigned to receive either 200 mg of modafinil, 400 mg of modafinil, or placebo
on a daily basis for the 8 weeks of treatment. During this time, participants will be asked
to report the number of days that they use and do not use cocaine. This will be confirmed
three times a week with urine tests. Mood, level of daytime sleepiness, and symptoms of
cocaine withdrawal and cocaine "high" will be evaluated. Compliance with study medication
will be assessed with urine and blood tests. Medication side effects will be monitored
through physical examinations, routine lab tests, ECGs, and self-reports. Follow-up
evaluations will occur 4 and 8 weeks following the end of treatment.