1. In a double-blind study forty abstinent
hospitalized male patients with an alcoholic organic brain syndrome (OBS)
were treated for 6 weeks with either 200 mg modafinil or placebo.
2. Modafinil (CRL 40476) is a putative
central alpha-1 adrenergic agonist. It's pharmacological profile is quite
different from that of amphetamine, which can be seen by the lack of
peripheral sympathomimetic effects. The vigilance promoting effect of
modafinil has been shown previously in pharmaco-EEG and psychometric studies
as well as in clinical studies involving treatment of daytime sleepiness in
idiopathic hypersomniacs and narcoleptics.
3. The present clinical investigations
demonstrated that the spontaneous restitution of the alcoholic OBS was
significantly augmented and accelerated by modafinil.
4. Psychometric tests did not show
significant intergroup differences. Modafinil- and placebo-treated patients
improved continuously over the 6-week period.
5. Psychophysiological and autonomous nervous
system parameters were affected neither by placebo nor by modafinil.
6. Neurophysiological investigations by means
of quantitative pharmaco-EEG showed partly inconsistent findings. However,
superimposed dosages of modafinil (on the top of 6 weeks chronic
administration) induced a decrease of slow activity and an increase of alpha
activity suggesting an improvement of vigilance after the daily drug intake.
7. Considering the beneficial effects of modafinil in abstinent chronic
alcoholic patients, it may be said that activation and improvement of
adaptive behaviour by an alpha-adrenergic agonist could be regarded as a
therapeutic principle in the treatment of the OBS, eventually due to