Oxidative Balance in Opioid Therapy

Overview

The oxidative – antioxidative balance is the crucial mechanism of opioid-induced immunomodulation. Additionally, impairement of cognitive function during opioid therapy is another important side- effect. This phenomenon was clearly described in opioids abuse. This is interesting to evaluate the importance of this subjects in chronic pain patients. The aim of the study was to investigate the oxidative – antioxidative homeostasis and cognitive functions using serum total oxidative capacity (TOC) and total antioxidative capacity (TAC) tests and Brain Derivered Neutrophic Factor (BDNF) in patient with chronic non-cancer pain treated with opioids.

Full Title of Study: “Oxidative- Antioxidative Balance and Cognitive Functions During Opioid Therapy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 15, 2021

Detailed Description

The project was approved in Ethical Committee and supported by Medical University of Bialystok (Poland). The serum TOC and TAC measurements were performed in total group of 50 adult patients: Study Group – 36 patients with chronic Low-Back Pain with opioids pharmacotherapy and Control Group – 14 patients, healthy volunteers. In Study Group anthropometric parameters, duration in opioid therapy, type of opioid, total dose, and form of application were registered.TOC, TAC, and BDNF measurements were performed using ImAnOx, PerOx, BDNF tests (Immundiagnostik, Germany).Data were analyzed using non-parametric tests.

Interventions

  • Diagnostic Test: biochemical measurements
    • TOC,TAC, and BDNF measurements are performed using ImAnOx , PerOx and BDNF tests (Immundiagnostik, Germany)

Arms, Groups and Cohorts

  • Experimental: Study Group
    • Study Group – 36 patients with chronic Low-Back Pain with opioids pharmacotherapy
  • Active Comparator: Control Group
    • Control Group – 14 patients, healthy volunteers.

Clinical Trial Outcome Measures

Primary Measures

  • oxidative balance
    • Time Frame: 6 months of opioids therapy
    • measurements of total oxidative capacity and total antioxidative capacity
  • cognitive state
    • Time Frame: 6 months of opioids therapy
    • measurements of Brain-derived Neurotrophic Function

Participating in This Clinical Trial

Inclusion Criteria

  • minimally, 6 months opioid therapy in chronic Low- Back Pain Exclusion Criteria:

  • depression, steroids- local or systemic administration

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Medical University of Bialystok
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Urszula Kosciuczuk, Principal Investigator, Medical University in Bialystok

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