Clinical Trial: Effects of Transdermal Scopolamine on Occupational Performance
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Effects of Transdermal Scopolamine on Occupational Performance
Brief Summary: The purpose of this study is to determine the effects of Transdermal scopolamine vs. placebo on ship navigation performance under simulated heavy sea conditions.
Detailed Summary: 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.
Sponsor: Boston University
Current Primary Outcome: simulated ship navigation performance eight hours following Transdermal scopolamine application
Original Primary Outcome: Same as current
Current Secondary Outcome: effectiveness of psychomotor vigilance testing as a fitness-for-duty test
Original Secondary Outcome: Same as current
Information By: Boston University
Dates:
Date Received: February 2, 2006
Date Started: April 2005
Date Completion:
Last Updated: April 6, 2007
Last Verified: April 2007