NCT00374478

Effects of Transdermal Scopolamine on Occupational Performance

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (planned)
• Sponsor: Boston University · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Accepted

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 description

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.

Conditions

• Motion Sickness

Interventions

Type	Name	Description
DRUG	Scopolamine

Timeline

• Start date: 2005-04-01
• Completion: 2006-04-01
• First posted: 2006-09-11
• Last updated: 2007-04-09

Locations

1 site across 1 country: Sweden