OpioidRedoxStudyII

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.

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