Effects of ceronapril alone or in combination with alcohol on psychomotor performance in healthy volunteers: A placebo-controlled, crossover study

Background: Behavioral evidence from animal studies has suggested that cero napril and other angiotensin-converting enzyme (ACE) inhibitors have some a nxiolytic activity. Objectives: The objectives of this trial were to assess the effects of cero napril, a centrally acting ACE inhibitor, on psychomotor performance in hea lthy volunteers; to compare its effects with those of lorazepam, a known an xiolytic agent; and to determine whether ceronapril interacts pharmacodynam ically with alcohol. Methods: Twelve healthy male volunteers received ceronapril (80 mg), loraze pam (2 mg), or corresponding placebo twice daily for 7 days in a randomized , double-blind, placebo-controlled, crossover study. Psychomotor tests were performed on days 1 and 7 of each treatment period. On the testing days, t he subjects ingested alcohol (1 g/kg) over a 30-minute period, 2 hours afte r drug administration. Psychomotor tests (simulated driving task, critical flicker fusion, body sway, lateral-gaze nystagmus, Maddox wing test, Mini-M ental State Examination, and subjective assessments) were performed before the administration of the morning dose and 1 hour, 3 hours (40 minutes post -alcohol), and 4 hours (100 minutes post-alcohol) after drug administration . Results: On day 1, ceronapril did not impair psychomotor performance, and i ts effects were comparable to those of placebo before and after alcohol ing estion. Lorazepam impaired most of the psychomotor functions, and its effec ts were enhanced by alcohol. On day 7, ceronapril decreased systolic blood pressure, but otherwise its effects were similar to those of placebo. Due t o development of tolerance, lorazepam had few psychomotor effects after the subchronic administration. Conclusions: Ceronapril was found to have no anxiolytic effects or effects on psychomotor performance in this sample of healthy volunteers.