Development of dosing guidelines for reaching selected target breath alcohol concentrations

Objective: This study evaluated gender-specific ethanol dosing protocols that were designed to result in one of two peak breath alcohol concentrations (BrACs)-0.07 or 0.10 g/2101. Inter- and intrasubject variability in BrAC were assessed and several possible methods for reducing variability in BrAC were evaluated. Method: Subjects (16 women, 16 men, ages 21-30 years) were studied after low (women 0.49 g/kg, men 0.53 g/kg consumed over 10 minutes) and high (women 0.81 g/kg, men 0.89 g/kg consumed over 20 minutes) ethanol doses, consumed following a 4-hour fast. All subjects were regular drinkers. Results: Mean (+/-SD) peak BrACs actually achieved were 0.069 +/- 0.011 g/2101 after the low dose, and 0.105 +/- 0.014 g/2101 after the high dose. Mean values for peak BrAC, time to peak BrAC and area under the curve were not statistically significantly different between genders at either dose. BrACs varied by as much as twofold between subjects after equivalent gender and body weight adjusted doses. There was some reproducibility of ethanol pharmacokinetic parameters over dose and time in men, but not in women. Conclusions: The doses used resulted in equivalent mean ethanol exposures for women and men at each dose, with mean peak BrACs that closely approached the targets, but there was substantial inter- and intrasubject variability in ethanol pharmacokinetics.