search
Back to results

Effects of Transdermal Scopolamine on Occupational Performance

Primary Purpose

Motion Sickness

Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Scopolamine
Sponsored by
Boston University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Motion Sickness focused on measuring Scopolamine, Antiemetic, Task performance and analysis, Psychomotor vigilance test

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Kalmar Maritime Academy

Outcomes

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

Full Information

First Posted
February 2, 2006
Last Updated
April 6, 2007
Sponsor
Boston University
Collaborators
Centers for Disease Control and Prevention
search

1. Study Identification

Unique Protocol Identification Number
NCT00374478
Brief Title
Effects of Transdermal Scopolamine on Occupational Performance
Official Title
Effects of Transdermal Scopolamine on Occupational Performance
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Boston University
Collaborators
Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Motion Sickness
Keywords
Scopolamine, Antiemetic, Task performance and analysis, Psychomotor vigilance test

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
33 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Scopolamine
Primary Outcome Measure Information:
Title
simulated ship navigation performance eight hours following Transdermal scopolamine application
Secondary Outcome Measure Information:
Title
effectiveness of psychomotor vigilance testing as a fitness-for-duty test

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Howland, Ph.D., MPH
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kalmar Maritime Academy
City
Kalmar
ZIP/Postal Code
SE-391 82
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

Effects of Transdermal Scopolamine on Occupational Performance

We'll reach out to this number within 24 hrs