- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00374478
Effects of Transdermal Scopolamine on Occupational Performance
April 6, 2007 updated by: Boston University
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 Overview
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.
Study Type
Interventional
Enrollment
33
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kalmar, Sweden, SE-391 82
- Kalmar Maritime Academy
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 20-60 years of age;
- English speaking;
- Marine cadets and officers with ship handling experience who volunteer for the study and agree to participate in ship simulation familiarization training prior to study commencement;
- Agree to refrain from alcohol use for 24 hours prior to dosing;
- Agree to stay on Kalmar Maritime Campus after scopolamine or placebo drug patch is applied and until study staff approves dismissal;
- Agree to remain at study site until passing sobriety test and dry mouth assessment;
- Agree to refrain from driving and operating heavy machinery after patch is applied and for 24 hours following patch removal;
- Agree to refrain from alcohol use 24 hours following patch removal at Sessions Two and Three;
- Agree to surrender car keys upon arrival at study site;
- Agree to receive a cab ride home from study;
- Females who are not pregnant as measured by a home pregnancy test prior to application of Transdermal scopolamine;
- Females who are using reliable birth control, per self report, not taking prescription or non prescription drugs contraindicated for Transdermal scopolamine use;
- Must weigh between 130 ( 58.9 7kgs)-260( 117.93 kgs) pounds;
- Must score less than a 5 on the Short Version- Michigan Alcohol Screening Test;
- No history of medical conditions contraindicated for Transdermal scopolamine use.
Exclusion Criteria:
- Individuals who are under 20 years of age or older than 60;
- Non-English speaking;
- Females who are pregnant (as measured by EPT pregnancy test prior to application of Transdermal scopolamine);
- Females who are not using reliable birth control, per to self report;
- A score of 5 or more on the SMAST (Short Version- Michigan Alcohol Screening Test);
- Reported use of recreational drugs;
- Reported history of treatment for alcohol or substance abuse;
- Currently taking prescription or non-prescription medications contraindicated for use with Transdermal scopolamine as per Physician's Desk Reference (including sedatives, tranquilizers, belladonna alkaloids, antihistamines, tricyclic antidepressants, and muscle relaxants);
- Reported history of medical conditions contraindicated for Transdermal scopolamine use (including pyloric obstruction, urinary bladder neck obstruction, impaired liver or kidney function, glaucoma, heart condition, obstructions to the stomach or intestines, prostrate enlargement, seizure history or psychosis);
- Participants weighing less than 130 lbs ( 58.9 7kg) and greater than 260( 117.93 kg);
- Allergic to adhesive materials; alcohol consumption 24 hours prior to dosing.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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simulated ship navigation performance eight hours following Transdermal scopolamine application
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Secondary Outcome Measures
Outcome Measure |
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effectiveness of psychomotor vigilance testing as a fitness-for-duty test
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jonathan Howland, Ph.D., MPH, Boston University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2005
Study Completion (Actual)
April 1, 2006
Study Registration Dates
First Submitted
February 2, 2006
First Submitted That Met QC Criteria
September 8, 2006
First Posted (Estimate)
September 11, 2006
Study Record Updates
Last Update Posted (Estimate)
April 9, 2007
Last Update Submitted That Met QC Criteria
April 6, 2007
Last Verified
April 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Motion Sickness
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Antiemetics
- Gastrointestinal Agents
- Adjuvants, Anesthesia
- Mydriatics
- Scopolamine
- Butylscopolammonium Bromide
Other Study ID Numbers
- CDC R49/CCR115279-5
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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