NCT00374478

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 11, 2006

Completed
Last Updated

April 9, 2007

Status Verified

April 1, 2007

First QC Date

February 2, 2006

Last Update Submit

April 6, 2007

Conditions

Motion Sickness

Keywords

ScopolamineAntiemeticTask performance and analysisPsychomotor vigilance test

Outcome Measures

Primary Outcomes (1)

  • simulated ship navigation performance eight hours following Transdermal scopolamine application

Secondary Outcomes (1)

  • effectiveness of psychomotor vigilance testing as a fitness-for-duty test

Interventions

ScopolamineDRUG

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kalmar Maritime Academy

Kalmar, SE-391 82, Sweden

Location

MeSH Terms

Conditions

Motion Sickness

Interventions

Scopolamine

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsBelladonna AlkaloidsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Study Officials

  • Jonathan Howland, Ph.D., MPH

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 2, 2006

First Posted

September 11, 2006

Study Start

April 1, 2005

Study Completion

April 1, 2006

Last Updated

April 9, 2007

Record last verified: 2007-04

Locations

SE(1)