Comparison of Intranasal and Oral Scopolamine for Motion Sickness Prevention in Military Personnel; Final rept. Feb 2005-Jul 2008

摘要

Results from preliminary studies indicate intranasal scopolamine (IN SCOP) has faster absorption, higher bioavailability, and a more reliable therapeutic index than equivalent oral (PO SCOP). The purpose of this study was to determine and compare the efficacy, side effect profile, and pharmacotherapeutics of IN SCOP and PO SCOP. It was hypothesized that IN SCOP would rapidly achieve therapeutic concentrations at lower doses compared to PO SCOP while minimizing medication-induced performance impairment. Fifty-four aviation candidates were randomized to one of three treatment groups (0.4 mg IN SCOP gel, 0.8 mg PO SCOP or placebo) and then exposed to passive Coriolis cross- coupling. Medication efficacy, pharmacotherapeutics and side-effect profiles were tracked for all groups. Analysis revealed there were no significant differences in efficacy among groups. Pharmacotherapeutic data show increased scopolamine absorption and decreased time to reach maximum salivary concentration with intranasal administration, with no significant treatment side effects detected over time. There was a significant decrease in heart rate over time for IN SCOP and PO SCOP versus placebo, while no clinically significant differences were found for either systolic or diastolic blood pressures. In summary, IN SCOP absorption was significantly greater than PO SCOP with no detrimental impact on performance or side effects.