Effects of amitriptyline and zimelidine in combination with ethanol.

Six healthy male volunteers took part in this three-period crossover study. In each session, a dose of trial drug -- either placebo, zimelidine 200 mg, or amitriptyline 75 mg -- was given at 09.00 h. Ethanol (50 g) was taken orally at 1200 h. Blood samples were taken for measurement of drug and ethanol concentrations, and body sway and subjective sedation were determined. No differences in the pharmacokinetics of ethanol were seen between the three treatment sessions. Amitriptyline and ethanol showed marked sedative effects, and the results suggest that these two effects may be additive. The combination of amitriptyline and ethanol results in a particularly marked increase in body sway. No sedative nor alerting effect of zimelidine was seen, nor was any interaction between zimelidine and ethanol apparent.

RCT Entities:   Population Interventions Outcomes