Effects of Transdermal Scopolamine on Occupational Performance

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00374478
• Date of registration: 02/02/2006
• Prospective Registration: No
• Primary sponsor: Boston University
• Public title: Effects of Transdermal Scopolamine on Occupational Performance
• Scientific title: Effects of Transdermal Scopolamine on Occupational Performance
• Date of first enrolment: April 2005
• Target sample size: 33
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00374478
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Prevention
• Phase: Phase 2

Countries of recruitment

Sweden

Contacts

• Name: Jonathan Howland, Ph.D., MPH
• Affiliation: Boston University

Key inclusion & exclusion 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.



Age minimum: 20 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Motion Sickness

Intervention(s)

Drug: Scopolamine

Primary Outcome(s)

simulated ship navigation performance eight hours following Transdermal scopolamine application

Secondary Outcome(s)

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

Secondary ID(s)

CDC R49/CCR115279-5

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Centers for Disease Control and Prevention