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Next‐day residual effects of gabapentin, diphenhydramine, and triazolam on simulated driving performance in healthy volunteers: a phase 3, randomized, double‐blind, placebo‐controlled, crossover trial
Author(s) -
Kay Gary G.,
Schwartz Howard I.,
Wingertzahn Mark A.,
Jayawardena Shyamalie,
Rosenberg Russell P.
Publication year - 2016
Publication title -
human psychopharmacology: clinical and experimental
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.461
H-Index - 78
eISSN - 1099-1077
pISSN - 0885-6222
DOI - 10.1002/hup.2530
Subject(s) - placebo , crossover study , diphenhydramine , anesthesia , medicine , gabapentin , triazolam , randomized controlled trial , benzodiazepine , alternative medicine , receptor , pathology , histamine
Objective Next‐day residual effects of a nighttime dose of gabapentin 250 mg were evaluated on simulated driving performance in healthy participants in a randomized, placebo‐controlled, double‐blind, multicenter, four‐period crossover study that included diphenhydramine citrate 76 mg and triazolam 0.5 mg. Methods At treatment visits, participants ( n = 59) were dosed at ~23:30, went to bed immediately, and awakened 6.5 h postdose for evaluation. The primary endpoint was the standard deviation of lateral position for the 100‐km driving scenario. Additional measures of driving, sleepiness, and cognition were included. Results Study sensitivity was established with triazolam, which demonstrated significant next‐day impairment on all driving endpoints, relative to placebo ( p < 0.001). Gabapentin demonstrated noninferiority to placebo on standard deviation of lateral position and speed deviation but not for lane excursions. Diphenhydramine citrate demonstrated significant impairment relative to gabapentin and placebo on speed deviation ( p < 0.05). Other comparisons were either nonsignificant or statistically ineligible per planned, sequential comparisons. Secondary endpoints for sleepiness and cognitive performance were supportive of these conclusions. Conclusions Together, these data suggest that low‐dose gabapentin had no appreciable next‐day effects on simulated driving performance or cognitive functioning. Copyright © 2016 John Wiley & Sons, Ltd.