Lack of interaction between two antihistamines, mizolastine and cetirizine, and ethanol in psychomotor and driving performance in healthy subjects

Abstract

The pharmacodynamic interaction between mizolastine, a new H1 antihistamine, and ethanol was assessed in a randomized, double-blind, three-way crossover, placebo-controlled study. Eighteen healthy young male volunteers received mizolastine 10 mg, or cetirizine 10 mg or placebo once daily for 7 days with a 1-week wash-out interval. An oral dose of ethanol or ethanol placebo, given 2 h after dosing on days 5 or 7 of each treatment period, was administered to achieve a peak blood alcohol concentration (BAC) of 0.7 g/l then maintained for 1 h by two further doses of ethanol. Driving ability and psychomotor performance were evaluated using actual and simulated driving tests, critical flicker fusion threshold (CFF), adaptive tracking and divided attention (DAT) tasks. Ethanol produced a significant decrement in all tasks up to 5.5 h after administration: an increase in steering movements of 4.6, in lateral deviation of 0.45 m, in braking reaction time of 80 ms, in driving test and DAT performance of + 3.2; and a decrease in CFF and in tracking speed of 2.6 m.s-1. Neither mizolastine nor cetirizine significantly impaired driving ability or arousal (CFF) compared with the placebo. However, both drugs significantly impaired DAT performance 6:00 h post-dose (increase of + 2.1 for mizolastine and + 2.4 for cetirizine). The tracking speed was significantly decreased 7:50 h after mizolastine administration (-1.3 m.s-1) and more consistently from 1:30 to 7:50 h after cetirizine administration (-1.4 m.s-1). No significant adverse interaction, i.e. potentiation, occurred between ethanol and either antihistamine.(ABSTRACT TRUNCATED AT 250 WORDS)

Pharmacodynamic interactions of a solid formulation of sodium oxybate and ethanol in healthy volunteers

“…482 / 80:3 / Br J Clin Pharmacol by psychotropic drugs [44][45][46][47] and is in the range of the legal breath alcohol concentration (BrAC) limits tolerated in a wide range of European countries.…”

“…This method was also demonstrated to be sensitive to both sedativelike and stimulant-like effects of various psychotropic drugs [44], including alcohol effects [45][46][47][48]. Different types of eye movements are sensitive to alcohol effects (for a review see [41]).…”

“…Choice reaction time (CRT) Alcohol impairs the speed of information processing in complex attentional tasks [41,46,54] and leads to reaction time increases in choice reaction time tasks [46,54,55].…”

“…The dose of alcohol (0.7 g kg -1 alcohol for males and 0.57 g kg -1 alcohol for females) was proven to induce mild effects on objective and subjective cognitive measures [41][42][43]. This dose is also able to be potentiated N. Pross et al482 / 80:3 / Br J Clin Pharmacol by psychotropic drugs [44][45][46][47] and is in the range of the legal breath alcohol concentration (BrAC) limits tolerated in a wide range of European countries.Placebo for alcohol: Blinding was achieved by giving 300 ml apple juice. Apple juice was provided by Biotrial from commercially available batches.…”

“…Measurements of body sway (1 min with eyes open and 1 min with eyes closed) were recorded as recommended by the International Society of Posturography [53]. The length (x axis and y axis) and area of the postural oscillations were then calculated.Choice reaction time (CRT) Alcohol impairs the speed of information processing in complex attentional tasks [41,46,54] and leads to reaction time increases in choice reaction time tasks [46,54,55].This test evaluated the speed at which a subject was able to respond to a complex visual stimulus. Performance was assessed as the speed of processing (in ms), and the answer accuracy expressed as the percentage of correct answers.…”