Effects of Transdermal Scopolamine on Occupational Performance
The purpose of this study is to determine the effects of Transdermal scopolamine vs. placebo on ship navigation performance under simulated heavy sea conditions.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Prevention
|Official Title:||Effects of Transdermal Scopolamine on Occupational Performance|
- simulated ship navigation performance eight hours following Transdermal scopolamine application
- effectiveness of psychomotor vigilance testing as a fitness-for-duty test
|Study Start Date:||April 2005|
|Study Completion Date:||April 2006|
Our study proposes to use a randomized crossover placebo controlled design to test the effects of transdermal scopolamine vs. placebo on simulated ship navigation performance under conditions of heavy seas. We hypothesize that mariners will experience a greater decrement in navigational performance in the placebo condition vs. transdermal scopolamine, when faced with simulated heavy seas. Study staff will apply the transdermal scopolamine patch or placebo patch, 8 hours prior to performance assessment. Participants will surrender car keys and will agree stay on the Kalmar Maritime Campus until they are dismissed from the study. A study nurse and/or study physician will be on call from the time of patch application until study participants are dismissed from the study. Eight hours following patch application participants will perform navigation tasks, under stormy weather conditions, in the bridge simulation lab at Kalmar Maritime Academy. Participants will repeat the protocol one week later under the opposite dosing condition. This study will be conducted at the Kalmar Maritime Academy, Kalmar, Sweden.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00374478
|Kalmar Maritime Academy|
|Kalmar, Sweden, SE-391 82|
|Principal Investigator:||Jonathan Howland, Ph.D., MPH||Boston University|