Actively Recruiting
Combination of Intranasal Scopolamine and Sensory Augmentation to Mitigate G-transition Induced Motion Sickness and Enhance Sensorimotor Performance
Led by Repurposed Therapeutics, Inc. · Updated on 2024-05-16
80
Participants Needed
1
Research Sites
264 weeks
Total Duration
On this page
Sponsors
R
Repurposed Therapeutics, Inc.
Lead Sponsor
N
National Aeronautics and Space Administration (NASA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The primary specific aim of this Field Test aim is to evaluate the feasibility and efficacy of administering the intranasal scopolamine gel in operational field settings using both astronaut and ground-control subjects that are exposed to provocative motion as part of their assigned duties. For the ground-control subjects, these may include motion simulations (e.g., centrifuge), parabolic flights and/or Orion capsule recovery operations. Astronaut participants may choose to test Inscop during provocative preflight training exercises (e.g., centrifugation), and can choose to take the medication prophylactically to prevent symptoms or after symptom onset to treat motion sickness during the launch and/or landing mission phases. Both ground-control and astronaut participants will be required to test the medication during a training session to monitor for adverse side effects. Participants in the field test aim will complete short debrief questionnaires to capture motion sickness symptoms, side effects, and feasibility comments. The investigators will also include field "control" subjects who did not take (INSCOP) to comment on what countermeasures subjects used and their effectiveness. The investigators will be recruiting astronaut participants from free-flier missions (e.g., SpaceX Polaris Dawn), Private Astronaut Missions (e.g., Axiom), and standard missions to the International Space Station.
CONDITIONS
Official Title
Combination of Intranasal Scopolamine and Sensory Augmentation to Mitigate G-transition Induced Motion Sickness and Enhance Sensorimotor Performance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Astronauts assigned to spaceflight missions or test personnel involved in operational activities with provocative motion (e.g., simulations, parabolic flights)
- No neurologic, vestibular, or autonomic disorders
- No medical conditions worsened by scopolamine such as narrow-angle glaucoma or urinary retention
- Negative FDA-authorized COVID-19 test within 7 days before drug administration or no COVID-19 symptoms for 10 days prior
You will not qualify if you...
- Use of drugs causing CNS effects such as antihistamines, tricyclic antidepressants, or muscle relaxants
- Hypersensitivity to scopolamine, belladonna alkaloids, or any ingredient in the medication
- Pregnant women or women with a positive pregnancy test
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
NASA Johnson Space Center Neuroscience Laboratory
Houston, Texas, United States, 77058
Actively Recruiting
Research Team
B
Barry Feinberg, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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