Oxidative Balance in Opioid Therapy

February 17, 2021 updated by: Medical University of Bialystok

Oxidative- Antioxidative Balance and Cognitive Functions During Opioid Therapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Bialystok, Poland, 15-276
        • Urszula Kosciuczuk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • depression, steroids- local or systemic administration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Group
Study Group - 36 patients with chronic Low-Back Pain with opioids pharmacotherapy
Diagnostic test: biochemical measurements
TOC,TAC, and BDNF measurements are performed using ImAnOx , PerOx and BDNF tests (Immundiagnostik, Germany)
Active Comparator: Control Group
Control Group - 14 patients, healthy volunteers.
Diagnostic test: biochemical measurements
TOC,TAC, and BDNF measurements are performed using ImAnOx , PerOx and BDNF tests (Immundiagnostik, Germany)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Bialystok

Investigators

  • Principal Investigator: Urszula Kosciuczuk, Medical University in Bialystok

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2019

Primary Completion (Actual)

February 15, 2021

Study Completion (Actual)

February 15, 2021

Study Registration Dates

First Submitted

December 29, 2019

First Submitted That Met QC Criteria

January 10, 2020

First Posted (Actual)

January 13, 2020

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R-I-002/307/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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