Effects of Transdermal Scopolamine on Occupational Performance

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Boston University
ClinicalTrials.gov Identifier:
NCT00374478
First received: February 2, 2006
Last updated: April 6, 2007
Last verified: April 2007
  Purpose

The purpose of this study is to determine the effects of Transdermal scopolamine vs. placebo on ship navigation performance under simulated heavy sea conditions.


Condition Intervention Phase
Motion Sickness
Drug: Scopolamine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Effects of Transdermal Scopolamine on Occupational Performance

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • simulated ship navigation performance eight hours following Transdermal scopolamine application

Secondary Outcome Measures:
  • effectiveness of psychomotor vigilance testing as a fitness-for-duty test

Estimated Enrollment: 33
Study Start Date: April 2005
Study Completion Date: April 2006
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.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00374478

Locations
Sweden
Kalmar Maritime Academy
Kalmar, Sweden, SE-391 82
Sponsors and Collaborators
Boston University
Investigators
Principal Investigator: Jonathan Howland, Ph.D., MPH Boston University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00374478     History of Changes
Other Study ID Numbers: CDC R49/CCR115279-5
Study First Received: February 2, 2006
Last Updated: April 6, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Boston University:
Scopolamine
Antiemetic
Task performance and analysis
Psychomotor vigilance test

Additional relevant MeSH terms:
Motion Sickness
Signs and Symptoms
Butylscopolammonium Bromide
Scopolamine Hydrobromide
Adjuvants, Anesthesia
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Mydriatics
Neurotransmitter Agents
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014