Actively Recruiting
Optimizing Intranasal Scopolamine Gel to Reduce Motion Sickness and Improve Sensorimotor Performance During Spaceflight and Motion Exposure
Led by Repurposed Therapeutics, Inc. · Updated on 2024-05-16
80
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating the use of intranasal scopolamine gel (DPI-386) to help reduce motion sickness and improve sensorimotor performance. This study involves both astronauts on space missions and ground-control participants exposed to motion such as centrifuge training, parabolic flights, and capsule recovery operations. The goal is to test the medication's feasibility and effectiveness in real operational settings, with astronauts from missions like SpaceX Polaris Dawn, Axiom, and the International Space Station. Participants will self-administer a 0.4 mg dose of intranasal scopolamine gel during training and operational exposures to motion. They will learn to apply the medication in a 15-minute training session and complete debriefs about symptoms, side effects, and ease of use. Astronauts may take the drug before or after motion exposure to prevent or treat symptoms. Control participants may use other motion sickness medications such as promethazine or meclizine. Both groups will complete surveys before, during, and after exposure to capture symptom severity and medication effectiveness. Throughout the study, participants will complete questionnaires on motion sickness symptoms, side effects, and medication feasibility. Surveys will track symptoms daily during and after exposure, including nausea, vertigo, headache, and drowsiness. Researchers will measure motion sickness using the Pensacola Diagnostic Index nausea scale and assess symptom impact on functional tasks. The study includes a one-week monitoring period for outcome measures, with data collected on medication use and recovery recommendations.
CONDITIONS
Brief 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 COVID-19 test within 7 days before study drug administration or no symptoms up to 10 days prior
- Age between 18 and 65 years
You will not qualify if you...
- Taking drugs that cause central nervous system 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) prior to study drug administration
Duration - Up to 1 week of operational exposures and assessments
Participants self-administer intranasal scopolamine gel to prevent or treat motion sickness during operational activities involving provocative motion and complete short surveys about symptoms, side effects, and medication efficacy.
Initial 15-minute training and 15-minute debrief sessions; repeated self-administration with a 15-minute survey after each use during motion exposure; inflight and postflight surveys
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Frequently Asked Questions
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