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Not yet recruiting NCT07338084

OpioidRedoxStudyII

— Observational Oxidative Stress Opioid Use

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Oxidative Stress, Opioid Use. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Slovakia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

This observational study aims to examine the relationship between opioid use and redox balance in adults. Redox balance reflects the level of oxidative stress in the body, which is known to play an important role in many biological processes and diseases. Participants who use opioids will be included in the study. No experimental treatment or changes to current medical care will be provided as part of this study. Biological samples may be collected to assess redox-related biomarkers, and relevant clinical and demographic information will be recorded. The results of this study are expected to improve understanding of how opioid exposure is associated with redox balance in adults. This information may help inform future research on the biological effects of opioids and potential strategies to reduce harm associated with long-term opioid use.

Detailed description

Opioids are widely used for the management of acute and chronic pain; however, prolonged opioid exposure has been associated with a range of systemic effects beyond analgesia. Increasing evidence suggests that oxidative stress and alterations in redox balance may play a role in the biological effects of opioids, potentially contributing to tissue damage, inflammation, and other adverse outcomes.

The OpioidRedoxStudy II is an observational study designed to further investigate the association between opioid use and redox balance in adults. This study builds on previous findings by focusing on redox-related biomarkers that reflect oxidative and antioxidative processes in the human body. The study does not involve any experimental intervention, randomization, or modification of participants' current medical treatment.

Participants using opioids will be assessed using biological samples collected according to the study protocol. These samples will be analyzed for markers related to redox balance. In addition, relevant clinical, demographic, and opioid exposure data will be collected to allow for exploratory analyses of associations between opioid use patterns and redox-related measures.

The primary objective of this study is to characterize the relationship between opioid exposure and redox balance in adults. Secondary objectives include exploring potential associations between redox-related biomarkers and clinical characteristics. The findings of this study are intended to contribute to a better understanding of the biological effects of opioid use and to support future research aimed at reducing opioid-related harm.

Primary outcome measures

  • Redox Balance Assessed by Circulating Redox-Related Biomarkers [Time frame: At baseline (at enrollment)]
  • Association Between Genetic Variants Related to Opioid Metabolism and Opioid-Related Adverse Effects [Time frame: From enrollment to 12 months after enrollment]
Secondary outcome measures (2)
  • Chronification Risk Assessment [Time frame: At baseline (at enrollment)]
  • Pain Severity and Interference Assessed by the Brief Pain Inventory [Time frame: At baseline and during follow-up up to 12 months after enrollment]

Eligibility criteria

Inclusion criteria

  • Adults aged 18 years or older
  • Receiving opioid therapy (tramadol, tapentadol, morphine, fentanyl, or buprenorphine) as part of routine clinical care
  • Stable opioid treatment for at least a predefined minimum period prior to enrollment (according to the study protocol)
  • Ability to provide written informed consent
  • Ability to comply with study procedures, including blood sampling and completion of questionnaires

Exclusion criteria

  • Acute opioid intoxication or withdrawal at the time of enrollment
  • Use of investigational drugs or participation in another interventional clinical trial that could interfere with study outcomes
  • Severe acute illness or unstable medical condition that, in the investigator's judgment, would interfere with study participation
  • Known pregnancy or breastfeeding
  • Inability to provide informed consent
  • Any condition that, in the opinion of the investigator, would make participation unsafe or compromise the quality of the collected data

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Slovakia · 1 center
  • University of Pavol JoSef Safarik — Košice

Publications

  • Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38. PMID 8080219
  • Kotagal V, Pontone GM, Bohnen NI. Chronic pain and cognitive decline: exploring the link in aging and neurodegenerative disorders. Pain Med. 2015;16(3):430-442. PMCID: PMC4377400.
  • Martuliak I, Golubnitschaja O, Chvala L, Kapalla M, Ferencik M, Bubeliny M, Venglarcik M, Kocan L. Pain chronification risk assessment: advanced phenotyping and scoring for prediction and treatments tailored to individualized patient profile. EPMA J. 2024 Nov 15;15(4):739-750. doi: 10.1007/s13167-024-00383-3. eCollection 2024 Dec. PMID 39635026
  • Richie M, Koob GF, Schulteis G. Genetic variability in ABCB1 and analgesic response: implications for morphine efficacy. J Pain. 2018;19(10):1090-1098. doi:10.1016/j.jpain.2018.04.004.
  • in W, Zhang Y, Chen D, et al. ABCB1 C3435T polymorphism affects opioid dose requirements through P-glycoprotein-mediated transport. Biomed Pharmacother. 2024;172:114007. doi:10.1016/j.biopha.2024.114007.
  • Rakvag TT, Klepstad P, Baar C, Kvam TM, Dale O, Kaasa S, Krokan HE, Skorpen F. The Val158Met polymorphism of the human catechol-O-methyltransferase (COMT) gene may influence morphine requirements in cancer pain patients. Pain. 2005 Jul;116(1-2):73-8. doi: 10.1016/j.pain.2005.03.032. PMID 15927391
  • Ho KYY, Loh S, Lim JF, et al. Influence of OPRM1 and COMT polymorphisms on pain perception and opioid responses: a randomized controlled trial. Pharmacogenomics J. 2020;20(6):762-769. PMCID: PMC7651441.
  • Chidambaran V, Zhang X, Martin LJ, et al. Genetic predictors of postoperative respiratory depression after pediatric tonsillectomy: OPRM1 and ABCB1 variants. Pharmacogenomics J. 2015;15(5):430-435. PMID: 25349169.

Identifiers

NCT: NCT07338084 · B1112025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗