OpioidRedoxStudyII
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorEPC Education s.r.o.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
The study population consists of adult patients receiving opioid therapy as part of routine clinical care. Participants are treated with tramadol, tapentadol, morphine, fentanyl, or buprenorphine and are enrolled into predefined observational cohorts based on the type of opioid used. The study population includes individuals with ongoing opioid exposure who are able to provide informed consent and comply with study procedures.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
120 Participants
are grouped into 4 trial groupsGroup A: Group 1
Group B: Group 2
Group C: Group 3
Group D: Group 4
Trial outcomes
Primary outcomes
1
Redox Balance Assessed by Circulating Redox-Related Biomarkers
Assessment of redox balance using circulating redox-related biomarkers measured in blood-derived samples. Biomarker levels will be compared across opioid exposure cohorts to evaluate associations between opioid type and redox balance.
Time frame
At baseline (at enrollment)2
Association Between Genetic Variants Related to Opioid Metabolism and Opioid-Related Adverse Effects
Assessment of the association between selected genetic variants related to opioid metabolism and signaling and the occurrence of opioid-related adverse effects and treatment intolerance across opioid exposure cohorts.
Time frame
From enrollment to 12 months after enrollmentSecondary outcomes
1
Chronification Risk Assessment
Assessment of the risk of pain chronification using a validated pain chronification risk assessment questionnaire in adults receiving opioid therapy.
Time frame
At baseline (at enrollment)2
Pain Severity and Interference Assessed by the Brief Pain Inventory
Assessment of pain severity and pain-related interference with daily activities using the Brief Pain Inventory (BPI) questionnaire.
Time frame
At baseline and during follow-up up to 12 months after enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
EPC Education s.r.o.
Lead sponsor
Pavol Jozef Safarik University
Collaborator
F.D.Roosevelt Banska Bystrica Slovak Republic
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: