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Double-blinded placebo-controlled cross-over pilot trial of naltrexone to treat Gulf War Illness

Title
Double-blinded placebo-controlled cross-over pilot trial of naltrexone to treat Gulf War Illness
Publication Type
Journal Article
Research Type
Human
Reported as
Clinical Trial
Date
June 09, 2018
Authors
K.L. Brewer, A. Mainhart, W.J. Meggs
Institution
East Carolina University
Link
Abstract

BACKGROUND: 30% of Gulf War veterans developed Gulf War Illness (GWI) with chronic fatigue, pain, and neuropsychological disabilities.

PURPOSE: To assess the efficacy of low-dose naltrexone to treat GWI. Methods: A double-blinded, placebo-controlled crossover trial of naltrexone 4.5 mg/day was conducted. The Clinical global impression scale (CGIS), visual analogue scales (VAS), SF-36 Health Survey, and the Connors Continuous Performance Test assessed treatment response. ClinicalTrials.gov registry Identifier is NCT02206490.

RESULTS: Thirty-seven participants completed the protocol. 100% had upper airway inflammation on examination. 88% were overweight or obese. The CGIS detected improvement in 38% of patients (n = 14) (responders), with 6 of these patients reporting much improvement. Non-responders were rated as showing no change from baseline (n = 18; 49%), or were rated minimally worse (n = 5; 13%). On the SF-36 Health Survey, responders showed significantly less disability than non-responders with respect to emotional limitations (p = 0.01) as well as greater improvement on VAS scales for confusion (p < 0.01), vertigo (p = 0.03) and depression (p = 0.05). All enrolled participants had detectable levels of naltrexone in their serum at the end of the treatment period, with values ranging from 1.5to 18 ng/ml. Anecdotally, some subjects and their spouses felt that naltrexone should be continued after the study ended.

CONCLUSION: This pilot trial suggests low-dose naltrexone may be effective for some with GWI. Further study and consideration of other doses is needed.

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