OpioidRedoxStudyII

NCT07338084 | Not Yet Recruiting DMC

• 1 other identifier: B1112025
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oxidative Stress; Opioid Use

Outcome Measures

Primary Outcomes (2)

• 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.

  At baseline (at enrollment)

• 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.

  From enrollment to 12 months after enrollment

Secondary Outcomes (2)

• Chronification Risk Assessment

  At baseline (at enrollment)

• Pain Severity and Interference Assessed by the Brief Pain Inventory

  At baseline and during follow-up up to 12 months after enrollment

Study Arms (4)

Group 1

Tramadol Cohort

Group 2

Tapentadol Cohort

Group 3

Buprenorphine - Morphin Cohort

Group 4

Fentanyl Cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pavol Jozef Safarik University: collaborator
• F.D.Roosevelt Banska Bystrica Slovak Republic: collaborator
• EPC Education s.r.o.: lead

Study Sites (1)

University of Pavol JoSef Safarik

Košice, 04011, Slovakia

Location

Related Publications (11)

• 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 BACKGROUND

• 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.

  BACKGROUND

• 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 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 18713907 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood-derived samples, including serum and plasma, collected for the assessment of redox-related biomarkers. Samples will be retained for biochemical analyses and will not be used for DNA extraction.

Central Study Contacts

Ladislav Kocan, assoc. Prof MD

CONTACT

00421557891100; europainclinicsstudy@mail.com

Janka Vaskova, Prof. Dr. PhD.

CONTACT

janka.vaskova@upjs.sk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2026
• First Posted: January 13, 2026
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 31, 2029
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)