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Oxidative Balance in Opioid Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04227223
Recruitment Status : Active, not recruiting
First Posted : January 13, 2020
Last Update Posted : February 13, 2020
Sponsor:
Information provided by (Responsible Party):
Medical University of Bialystok

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain Opioids Diagnostic Test: biochemical measurements Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The serum 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. I
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Oxidative- Antioxidative Balance and Cognitive Functions During Opioid Therapy
Actual Study Start Date : September 25, 2019
Estimated Primary Completion Date : January 25, 2021
Estimated Study Completion Date : February 15, 2021

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)




Primary Outcome Measures :
  1. oxidative balance [ Time Frame: 6 months of opioids therapy ]
    measurements of total oxidative capacity and total antioxidative capacity

  2. cognitive state [ Time Frame: 6 months of opioids therapy ]
    measurements of Brain-derived Neurotrophic Function



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • depression, steroids- local or systemic administration

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04227223


Locations
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Poland
Urszula Kosciuczuk
Bialystok, Poland, 15-276
Sponsors and Collaborators
Medical University of Bialystok
Investigators
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Principal Investigator: Urszula Kosciuczuk Medical University in Bialystok
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Responsible Party: Medical University of Bialystok
ClinicalTrials.gov Identifier: NCT04227223    
Other Study ID Numbers: R-I-002/307/2019
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medical University of Bialystok:
neurological condition
opioids
oxidative balance
pain