A Phase 2 interventional study of Scopolamine in Motion Sickness, sponsored by Boston University. Completed at 1 site in Sweden. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-04-09.
Sponsored by Boston University · Phase 2, Interventional, and Prevention
The purpose of this study is to determine the effects of Transdermal scopolamine vs. placebo on ship navigation performance under simulated heavy sea conditions.
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.
50 studies on the registry are indexed under Motion Sickness; 9 are open to participants now.
This study's enrollment of 33 is below the median of 59 across 44 interventional studies indexed under Motion Sickness.
Browse Motion Sickness studies →Boston University is the lead sponsor of 270 studies on the registry; 36 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 24 (77%) have results posted.
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Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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simulated ship navigation performance eight hours following Transdermal scopolamine application
effectiveness of psychomotor vigilance testing as a fitness-for-duty test
This study is completed, as verified in Apr 2007. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Scopolamine