A STUDY OF THE PHARMACODYNAMIC INTERACTION BETWEEN BEFLOXATONE AND ETHANOL ON PERFORMANCE AND MOOD IN HEALTHY-VOLUNTEERS

The effects of befloxatone (20mg o.d. for 10 days) alone and in combin ation with ethanol on psychomotor performance, memory and mood were as sessed in a randomized, double-blind, placebo controlled study. On tre atment days 6, 8 and 10, subjects received 0.5 and 0.8 g/kg ethanol an d ethanol placebo in randomly assigned, balanced orders, 2h post-drug. Critical fusion frequency, choice reaction time, postural instability , critical tracking and mood were measured Ih before ethanol and 1, 3 and 5h afterwards. Divided attention, sustained attention and memory ( immediate and delayed recall) were also measured in single tests, 2.5- 5h post-ethanol. Ethanol's effects were generally significant when blo od alcohol concentrations (BAG) after both doses were the highest; i.e . 0.48-0.67 and 0.96-1.10 mg/ml. Those effects were virtually gone aft er the subjects' mean BACs fell below 0.40 mg/ml. Befloxatone alone ha d no significant impairing effect in any test. Neither did it signific antly interact with ethanol to cause any greater impairment than the l atter alone. It was concluded that befloxatone does not potentiate-the sedating and impairing effects of ethanol.