drugset / Trial / NCT02469077

Reduced Opioid Analgesic Requirements Via Improved Endogenous Opioid Function

NCT02469077 ↗

RandomizedParallel-groupDouble-blindTreatment

Summary

Chronic Pain (CP) management has increasingly utilized long-term opioid analgesic therapy, a change associated with increased opioid abuse (via greater exposure in vulnerable individuals), non-pain health consequences (hormone changes, falls), and a dramatic rise in opioid-related overdoses and deaths. Treatment strategies that minimize the need for chronic high-dose opioids are sorely needed. This project will test the novel hypothesis that effective pain relief can be achieved at lower opioid analgesic doses by increasing levels of endogenous opioids (EOs).

Timeline

Start
2015-08
Primary completion
2019-09
Completion
2019-09

Outcome

Mixed primary results

registry analysis (superiority test); 6 Week Aerobic Exercise Intervention vs Normal Exercise (Control); p = 0.12; ANCOVA NCT02469077 ↗

registry analysis (superiority test); 6 Week Aerobic Exercise Intervention vs Normal Exercise (Control); p = .04; ANCOVA NCT02469077 ↗

registry MEAN 6 Week Aerobic Exercise Intervention: Change after 6 week intervention period: 0.72 (Standard Deviation 1.18) units on a scale NCT02469077 ↗

registry Positive values indicate reduced pain post intervention. NCT02469077 ↗

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Morphine Other / unclassified 0.02 mg/kg Intravenous
Subject Morphine Other / unclassified 0.03 mg/kg Intravenous
Subject Naloxone Small molecule 4 mg —
Subject Naloxone Small molecule 8 mg —

Indications