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Completed Research Projects
Title: Randomized, Controlled Trial for Combination Treatment with Pyridostigmine, DEET, and Permethrin
Synopsis: This study evaluated the effects of pyridostigmine bromide, permethrin, DEET, and stress on brain functions.
Overall Summary: See project objective.
Overall Project Objective: Determine the short-term safety and neurocognitive effects of combined treatment with standard application of DEET to skin, permethrin to uniforms, and Pyridostigmine bromide tablets 30 mg TID as employed for nerve agent prophylaxis, under stress and rest conditions.
Results to Date: Forty-seven subjects have provided informed consent and completed a baseline assessment. Twenty of them have completed the study, eight have withdrawn without completion due to schedule difficulties, and another nineteen are at various points in the course of the study. Two subjects are family members of active duty members, the remainder are active duty service members. Not including subjects who withdrew, thirteen are female; 24 are Caucasian, 9 are African-American, 4 are Asian, and 2 are Latino. The average age of subjects is 27. There have been no significant adverse effects to date. Preliminary results include:
1. Pyridostigmine bromide (PB), DEET, and permethrin can be rapidly and sensitively assayed in human plasma samples.
2. Permethrin applied to Battle Dress Uniforms does not enter the bloodstream at detectable levels, whereas DEET applied to the skin, and PB ingested orally, are readily detectable.
3. Combined exposure to PB, DEET, and permethrin does not appear to have significant effects on physical or neurocognitive performance, whether under stress or rest conditions. However, it must be emphasized that this is based upon a limited number of subjects at this point, and it will only be upon completion of the entire study that we expect to have sufficient power to be able to say this with confidence.
Project: DOD-124
Agency: Department Of Defense
Location: The Henry M. Jackson Foundation
P.I. Name: Michael J Roy
Status: Complete
Study Start Date: October 01, 2000
Estimated Completion Date: April 30, 2005
Specific Aims: To determine the safety of combination treatment with DEET, Permethrin and Pyridostigmine.
Methodology: A prospective double-blinded placebo-controlled trial involving 64 subjects at 2 sites. Cross-over designed in which all subjects receive all possible combinations of treatment, placebo, stress, and rest.
Publications:
Cherstniakova S A, Garcia G E, Strong J , Bi D , Weitz J , Roy M J, Cantilena L R. J Anal Toxicol.2006;30:21-6.
Roy M J, Kraus P L, Cooper J A, Cherstniakova S A, Coll R , Seegers C A, Deuster P A, Koslowe P , Law W A, Krantz D S, Cantilena L . Mil Med.2006;171:122-7.
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