Addressing the Risks of Long-Term Opioid Therapy in Chronic Noncancer Pain
CompletedNCT03161795
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
PURPOSE: Assess the risks of long-term opioid therapy, especially opioid use disorders such as opioid-related chemical coping in chronic noncancer pain patients. Pain, particularly chronic pain, is a major threat to the quality of life worldwide and will become more so as the average age increases. Currently, over 30% of the world's population is known to have chronic pain. Among a plethora of treatment options, opioid agonists is one of treatment options for moderate to severe chronic pain. Although its consumption has increased during the last two decades,3 it remains below the requirements in most regions, including the Asian countries. In South Korea (S. Korea), opioid consumption for medical purposes in 2015 was still below average, ranked 43rd globally and 30th among 35 Organisation for Economic Co-operation and Development (OECD) countries (55 mg/capita in S. Korea vs. 258 mg/capita in an average of OECD countries). Conversely, in countries with high opioid consumption such as the United States of America (US), drug overdose deaths (the majority involving an opioid) have nearly quadrupled since 1999. The up to date literature on opioid use disorder (OUD) is characterized by great variability of definitions, measurements, demographics, and opioid use duration. Moreover, an overwhelming majority of the studies took place in the US, the country with the highest opioid consumption and a current opioid crisis. Additionally, stringent restrictions and regulations to prevent OUD may result in inadequate pain control and insufficient opioid therapy, especially in countries with relatively low-moderate opioid consumption rates. Therefore, in compliance with growth in medical opioid use and the lack of studies in countries with low-moderate opioid consumption, it is necessary to determine the occurrence of OUD in chronic noncancer pain (CNCP) patients receiving long-term opioid therapy (LtOT). In this study, we will perform a national, multicenter, observational cross-…
Study details
- Official title
- Addressing the Risks of Long-Term Opioid Therapy in Chronic Noncancer Pain: A National, Multicenter, and Observational Cross-sectional Study in South Korea
- Conditions
- Chronic Noncancer Pain
- Opioid-Related Disorders
- Sponsor
- Seoul National University
- Collaborators
- Seoul National University Bundang Hospital; Korea University Guro Hospital; Ewha Womans University; Ajou University School of Medicine; Konkuk University Hospital; Chung-Ang University Hospital; Seoul St. Mary's Hospital
- Start date
- 2017-04-25
- Primary completion
- 2018-01-19
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- South Korea
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion criteria were as follows: 1) patients at age equal or greater than 18 years; 2) patients with a diagnosis of chronic pain defined by the American Chronic Pain Association (ACPA) as an ongoing or recurrent pain, lasting beyond the usual course of acute illness or injury or more than 3 months, and which adversely affected the individuals' well-being; 3) patients with CNCP with opioid medication for treatment and/or control of chronic pain; 4) patients who were receiving long-term opioid therapy defined as the use of opioids on most days for a period of time greater than 3 months; and 5) patients who complete the screening tools and questionnaires evaluated in the study. Exclusion criteria were as follows: 1) patients with diagnosis and/or ongoing cancer treatment or palliative or receiving end-of-life care; 2) patients younger than 18 years of age; 3) patients without current opioid therapy for the treatment and/or control of chronic pain; 4) patients with chronic pain that received opioid therapy intermittently or for less than 3 months; 5) serious systemic diseases (Myasthenia Gravis, decreased lung function, severe liver problems, severe renal impairment, shock, hypo- or hyperpotassemia) or psychiatric disorders (schizophrenia and acute anxiety) that compromise the patients safety or the completion of the survey; or 6) patients with intellectual impairment to answer the tools and questionnaires evaluated.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03161795