Pharmacodynamics of Promethazine in Human SubjectsPromethazine (PMZ) is the drug of choice for the treatment of symptoms associated with space motion sickness in astronauts. Side effects of PMZ include sedation, dizziness and cognitive performance impairment. In this study, we examined pharmacodynamics (PD) in human subjects and validated methods for evaluating cognitive performance effects of medications in space. METHODS: PMZ (12.5,25, and 50 mg) or placebo was administered by IM injection to human subjects in a randomized double-blind treatment design. Samples and data were collected for 72 h post dose. PD evaluation was performed using a battery of performance tests administered using WinSCAT (Windows based Space Cognitive Assessment Test) on a laptop computer, and ARES (ANAM Readiness Evaluation System) on a PDA, plasma concentrations of PMZ were measured using a LC-MS method. RESULTS: Results indicate a linear correlation between PMZ concentration and cognitive performance parameters (p<0.01). Test accuracy decreased and test completion time and response time increased significantly with increasing plasma PMZ concentration. CONCLUSIONS: These results suggest a concentration dependent decrement in cognitive performance associated with PMZ. WinSCAT and ARES are sensitive tools for the assessment PMZ PD and may be applicable for such evaluations with other neurocognitive drugs.
Document ID
20080047089
Acquisition Source
Johnson Space Center
Document Type
Conference Paper
Authors
Gatlin, K. T. (Wyle Labs., Inc. Houston, TX, United States)
Boyd, J. L. (Universities Space Research Association Houston, TX, United States)
Wang, Z. (Wyle Labs., Inc. Houston, TX, United States)
Das, H. (Enterprise Advisory Services, Inc. Houston, TX, United States)
Putcha, L. (NASA Johnson Space Center Houston, TX, United States)
Date Acquired
August 24, 2013
Publication Date
March 2, 2005
Subject Category
Aerospace Medicine
Meeting Information
Meeting: American Society of Clinical Pharmacology and Therapeutics 2005 Annual Meeting