Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
120 participants
OBSERVATIONAL
2026-06-30
2029-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1
Tramadol Cohort
No interventions assigned to this group
Group 2
Tapentadol Cohort
No interventions assigned to this group
Group 3
Buprenorphine - Morphin Cohort
No interventions assigned to this group
Group 4
Fentanyl Cohort
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
ALL
No
Sponsors
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Pavol Jozef Safarik University
OTHER
F.D.Roosevelt Banska Bystrica Slovak Republic
UNKNOWN
Europainclinics z.ú.
OTHER
Responsible Party
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Locations
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University of Pavol JoSef Safarik
Košice, , Slovakia
Countries
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Central Contacts
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References
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Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
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.
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.
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.
Stamer UM, Stuber F, Muders T, Musshoff F. Respiratory depression with tramadol in a patient with renal impairment and CYP2D6 gene duplication. Anesth Analg. 2008 Sep;107(3):926-9. doi: 10.1213/ane.0b013e31817b796e.
Zeng L, Zhen J, Wang T, et al. Thioredoxin-1 regulates morphine-induced addictive behavior through redox modulation in the nucleus accumbens. Front Pharmacol. 2020;11:573434. doi:10.3389/fphar.2020.573434.
Ahmadi A, Shadboorestan A, Ahmatkesh A. Opioid administration and oxidative stress: a review of the literature. J Opioid Manag. 2017;13(1):35-44. PMID: 28296619.
Other Identifiers
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B1112025
Identifier Type: -
Identifier Source: org_study_id
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