Motion SicknessPhase 2NCT00374478
Effects of Transdermal Scopolamine on Occupational Performance
A Phase 2 study testing Scopolamine in people with Motion Sickness, run by Boston University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Motion Sickness
- What is being tested?
- Scopolamine
- How many people
- 33 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2005to Apr 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the effects of Transdermal scopolamine vs. placebo on ship navigation performance under simulated heavy sea conditions.
Read the 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.
- Conditions
- Motion Sickness
- Being tested
- Scopolamine
- Keywords
- Scopolamine, Antiemetic, Task performance and analysis, Psychomotor vigilance test
- Medical subject headings
- Motion Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScopolamineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
simulated ship navigation performance eight hours following Transdermal scopolamine application
Secondary outcomes (1)
effectiveness of psychomotor vigilance testing as a fitness-for-duty test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2006 (estimated)
- Study startApr 2005
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motion SicknessStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 33 participants
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Investigators
- Jonathan Howland, Ph.D., MPH, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00374478
- Sponsor's protocol ID
- CDC R49/CCR115279-5
- Status last verified
- Apr 2007
- First submitted
- 2 Feb 2006
- Last updated
- 9 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transdermal Scopolamine on Occupational Performance
- ClinicalTrials.gov ID
- NCT00374478
- Acronym / sponsor ID
- CDC R49/CCR115279-5
- Conditions
- Motion Sickness
- Keywords
- Scopolamine, Antiemetic, Task performance and analysis, Psychomotor vigilance test
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Apr 2005
- Study completion
- Apr 2006 (actual)
- First posted
- 11 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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;
Key exclusion criteria (11 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scopolamine | Drug | – |
Primary outcome
simulated ship navigation performance eight hours following Transdermal scopolamine application
1 secondary outcome
effectiveness of psychomotor vigilance testing as a fitness-for-duty test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Howland, Ph.D., MPH principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Scopolamine in people with Motion Sickness, run by Boston University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
simulated ship navigation performance eight hours following Transdermal scopolamine application. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2007.