Cocaine-Related Disorders Clinical Trial
Official title:
A Double-Blind, Placebo-Controlled Study of Modafinil for Cocaine Dependence
Despite years of active research, there are still no approved medications for the treatment of cocaine dependence. The purpose of this study is to determine the effectiveness of modafinil in treating cocaine-dependent individuals.
Modafinil is a glutamate-enhancing agent that blunts cocaine euphoria under controlled
conditions. Due to its stimulant-like properties, modafinil is also likely to relieve severe
cocaine withdrawal symptoms. In turn, this may lead to better clinical outcomes. The purpose
of this study is to determine whether modafinil improves abstinence during early recovery
from cocaine dependence.
This 6-month, double-blind, placebo-controlled trial will enroll 210 participants with
current DSM-IV diagnoses of cocaine dependence. Treatment will occur for 8 weeks.
Participants will be randomly assigned to receive a single morning dose of low-dose modafinil
(200 mg/day), high-dose modafinil (400 mg/day), or matching placebo tablets. In addition,
each week participants will receive manual-guided cognitive behavioral therapy at the
Treatment Research Center. At the end of the 8-week treatment period, modafinil or placebo
will be abruptly discontinued. One week following, an end of medication evaluation will
occur. In addition to this, two follow-up evaluations will take place 3 and 5 months after
initial randomization. Efforts will be made to continue evaluation of subjects who decide to
discontinue the modafinil treatment. Urine benzoylecgonine levels will be used to measure
cocaine abstinence. Craving, withdrawal, retention, and adverse events will also be
evaluated.
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