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Ethanol Pharmacodynamics at Low Blood Concentrations
S. K. Gupta1, E. H. Ellinwood, K. T. Muir
1Department of Clinical Pharmacology, Glaxo Research Institute, R.T.P., NC, USA.
American Journal of Therapeutics
|May 1, 1996
Summary
Ranitidine may increase blood alcohol concentration (BAC) slightly. This study found that modest BAC increases (15-27 mg/dl) did not significantly impair cognitive performance in healthy males.
Area of Science:
- Pharmacology
- Toxicology
- Neuroscience
Background:
- Ranitidine is known to elevate blood alcohol concentration (BAC) after alcohol consumption.
- The clinical significance of these BAC elevations on cognitive function remains unclear.
Purpose of the Study:
- To investigate the impact of ranitidine-induced blood alcohol concentration (BAC) increases on cognitive performance.
- To validate study methodology by comparing effects of various ethanol doses against placebo and an active control.
Main Methods:
- A randomized, double-blind, placebo-controlled, four-way crossover study involving eight healthy males.
- Intravenous administration of ethanol at 0.10, 0.15, or 0.45 g/kg, or placebo.
- Measurement of BAC and cognitive function (digit symbol substitution, continuous tracking, divided attention) over 8 hours.
Main Results:
- Observed peak BACs for 0.10 and 0.15 g/kg ethanol doses closely matched target concentrations (15.2 and 27 mg/dl vs. 13 and 26 mg/dl).
- Analysis of variance revealed no significant differences in cognitive impairment measures for BACs between 15-27 mg/dl.
- Significant impairment was detected at the 0.45 g/kg dose (110 mg/dl BAC), validating the study's sensitivity.
Conclusions:
- Modest increases in blood alcohol concentration (BAC) from 15 to 27 mg/dl are not associated with significant cognitive impairment.
- The clinical relevance of ranitidine-induced BAC elevations is likely minimal due to the lack of substantial performance deficits.