Cognitive performance of patients with opioid use disorder transitioned to extended-release injectable naltrexone from buprenorphine: Post hoc analysis of exploratory results of a phase 3 randomized controlled trial

Introduction Considering the potential of weaponized opioids, evaluating how prophylactic countermeasures affect military-relevant performance is necessary. Naltrexone is a commercially available Food and Drug Administration–approved medication that blocks the effects of opioids with minimal side effects. However, the effects of naltrexone on the health and performance of non-substance abusing military personnel are not well described in the existing literature. Methods Active duty U.S. Army Soldiers (n = 16, mean ± SD, age: 23.1 ± 5.3 y) completed a series of physical, cognitive, and marksmanship tasks during a 4-day pretrial, a 7-day active trial, and a 4-day post-trial phase. During the active trial, participants were administered 50 mg of oral naltrexone daily. Physiological and biological processes were monitored with a daily review of systems, sleep monitoring, biochemistry, and hematology blood panels. Results Naltrexone did not negatively affect physical performance, cognitive functioning, marksmanship, or sleep duration (P > 0.05). Improvements were observed during the active trial compared to the pretrial phase in cognitive tasks measuring logical relations (P = 0.05), matching to sample (P = 0.04), math speed (P < 0.01), math percent correct (P = 0.04), and spatial processing (P < 0.01). Results from biochemistry and hematology blood panels remained within clinically normative ranges throughout all phases of the study. No participants were medically withdrawn; however, one participant voluntarily withdrew due to nausea and reduced appetite. Conclusions Temporary (7-day) daily use of naltrexone was safe and did not negatively affect physical performance, cognitive functioning, marksmanship ability, or sleep in a healthy cohort of U.S. Army Soldiers.

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Cognitive performance of patients with opioid use disorder transitioned to extended-release injectable naltrexone from buprenorphine: Post hoc analysis of exploratory results of a phase 3 randomized controlled trial

Cited by 4 publications

References 17 publications

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Daily Naltrexone Use Does Not Adversely Affect Physical, Cognitive or Marksmanship Performance in U.S. Army Soldiers

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