Addressing the Risks of Long-Term Opioid Therapy in Chronic Noncancer Pain
NCT ID: NCT03161795
Last Updated: 2022-11-08
Study Results
Results pending
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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Recruitment Status
COMPLETED
Total Enrollment
258 participants
Study Classification
OBSERVATIONAL
Study Start Date
2017-04-25
Study Completion Date
2018-03-12
Brief Summary
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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-sectional study to address the current status of opioid treatment for CNCP in S. Korea, a country with moderate opioid consumption. The ultimate aims of this study are to estimate the frequency of OUD such as OrCC, to evaluate the functional and psychiatric characteristics of patients, and to determine the risk factors associated with OUD in CNCP patients receiving LtOT.
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-sectional study to address the current status of opioid treatment for CNCP in S. Korea, a country with moderate opioid consumption. The ultimate aims of this study are to estimate the frequency of OUD such as OrCC, to evaluate the functional and psychiatric characteristics of patients, and to determine the risk factors associated with OUD in CNCP patients receiving LtOT.
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Detailed Description
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Chronic pain is a devastating disease often treated inadequately. More than 30 percent of the world population suffers from 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, 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). However, it is remarkable that the opioid consumption in S. Korea has increased 5-6 times since 2005 (10 mg/capita), ranking 3rd among Asian countries, preceded only by Vietnam (62 mg/capita) and Malaysia (60 mg/capita).
One of the reluctant factors to prescribe opioids is induced reward responses, resulting in opioid use disorders (OUD). Particularly, in chronic noncancer pain (CNCP), concerns regarding drug dependence in the long-term opioid therapy (LtOT) remain its use controversial. The spectrum of OUD in CNCP patients is wide and varies from misuse without a compliant intake to addiction with a severe aberrant consumption. Between the extremes, opioid-related chemical coping (OrCC) may lie in a middle ground group, characterized by an inappropriate use of opioids to cope with emotional distress. Although, OrCC is a terminology first used in cancer patients, a recent study found a high correlation between the reports of aberrant medication-taking behavior by experienced providers and chemical coping by CNCP patients.
OrCC should be distinguished from psychologic addiction, a neurobiological disease that corresponds with the most severe substance-use disorder referring to neuroplasticity and a substantial loss of self-control. All addicts are eventually chemical copers, but not all chemical copers are addicts. A better understanding of this intermediate status may be crucial to prompt to identify the risk of severe OUD and re-direct their management to avoid unnecessary opioid toxicity and achieve adequate pain control. However, studies to measure OrCC are scarce and the evidence of OUD in CNCP in countries with relatively low opioid consumption is practically unavailable.
The up to date literature on 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 United Stated of America (US), the country with the highest opioid consumption and a current opioid crisis. Despite their over-consumption, however, studies in those countries showed that CNCP is still undertreated and even suggested that OUD might not be related to the prescription to pain patients. From a different angle, 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, to strike a balance when treating pain with opioids, it is indispensable to determine the characteristics of OUD in CNCP patients with LtOT in countries with low-moderate opioid consumption. Moreover, in S. Korea there are not available statistics regarding the OUD occurrence in CNCP patients and national guidelines on LtOT in CNCP have not been developed.
In this study, we will perform a national, multicenter, observational cross-sectional study to address the current status of opioid treatment and OUD for CNCP in S. Korea, a country with moderate opioid consumption since 2010. The availability of up-to-date data on OUD is necessary for the development of national guidelines to prevent severe harms of opioids, enhance patients and physicians' satisfaction, potentiate opioid's benefits, and guaranty adequate pain control in the CNCP population. The ultimate aims of this study are to estimate the frequency of OUD (such as OrCC), to evaluate the patient's functional and psychiatric characteristics, and to determine the risk factors associated with OUD in CNCP patients receiving LtOT. The results of this study will help to seize the occurrence of OUD in countries with low-moderate opioid consumption thus it will approach the real risk effect of LtOT in CNCP.
One of the reluctant factors to prescribe opioids is induced reward responses, resulting in opioid use disorders (OUD). Particularly, in chronic noncancer pain (CNCP), concerns regarding drug dependence in the long-term opioid therapy (LtOT) remain its use controversial. The spectrum of OUD in CNCP patients is wide and varies from misuse without a compliant intake to addiction with a severe aberrant consumption. Between the extremes, opioid-related chemical coping (OrCC) may lie in a middle ground group, characterized by an inappropriate use of opioids to cope with emotional distress. Although, OrCC is a terminology first used in cancer patients, a recent study found a high correlation between the reports of aberrant medication-taking behavior by experienced providers and chemical coping by CNCP patients.
OrCC should be distinguished from psychologic addiction, a neurobiological disease that corresponds with the most severe substance-use disorder referring to neuroplasticity and a substantial loss of self-control. All addicts are eventually chemical copers, but not all chemical copers are addicts. A better understanding of this intermediate status may be crucial to prompt to identify the risk of severe OUD and re-direct their management to avoid unnecessary opioid toxicity and achieve adequate pain control. However, studies to measure OrCC are scarce and the evidence of OUD in CNCP in countries with relatively low opioid consumption is practically unavailable.
The up to date literature on 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 United Stated of America (US), the country with the highest opioid consumption and a current opioid crisis. Despite their over-consumption, however, studies in those countries showed that CNCP is still undertreated and even suggested that OUD might not be related to the prescription to pain patients. From a different angle, 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, to strike a balance when treating pain with opioids, it is indispensable to determine the characteristics of OUD in CNCP patients with LtOT in countries with low-moderate opioid consumption. Moreover, in S. Korea there are not available statistics regarding the OUD occurrence in CNCP patients and national guidelines on LtOT in CNCP have not been developed.
In this study, we will perform a national, multicenter, observational cross-sectional study to address the current status of opioid treatment and OUD for CNCP in S. Korea, a country with moderate opioid consumption since 2010. The availability of up-to-date data on OUD is necessary for the development of national guidelines to prevent severe harms of opioids, enhance patients and physicians' satisfaction, potentiate opioid's benefits, and guaranty adequate pain control in the CNCP population. The ultimate aims of this study are to estimate the frequency of OUD (such as OrCC), to evaluate the patient's functional and psychiatric characteristics, and to determine the risk factors associated with OUD in CNCP patients receiving LtOT. The results of this study will help to seize the occurrence of OUD in countries with low-moderate opioid consumption thus it will approach the real risk effect of LtOT in CNCP.
Conditions
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Chronic Noncancer Pain
Opioid-Related Disorders
Study Design
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Observational Model Type
OTHER
Study Time Perspective
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
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.
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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Seoul National University Bundang Hospital
OTHER
Sponsor Role
collaborator
Korea University Guro Hospital
OTHER
Sponsor Role
collaborator
Ewha Womans University
OTHER
Sponsor Role
collaborator
Ajou University School of Medicine
OTHER
Sponsor Role
collaborator
Konkuk University Hospital
OTHER
Sponsor Role
collaborator
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
OTHER
Sponsor Role
collaborator
Seoul St. Mary's Hospital
OTHER
Sponsor Role
collaborator
Seoul National University
OTHER
Sponsor Role
lead
Responsible Party
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Jeeyoun Moon
Clinical Associate Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Jee Y Moon, MD, PhD
Role: STUDY_DIRECTOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Site Status
Countries
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South Korea
References
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Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Mil Med. 2016 May;181(5):397-9. doi: 10.7205/MILMED-D-16-00012. No abstract available.
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Krnic D, Anic-Matic A, Dosenovic S, Draganic P, Zezelic S, Puljak L. National consumption of opioid and nonopioid analgesics in Croatia: 2007-2013. Ther Clin Risk Manag. 2015 Aug 28;11:1305-14. doi: 10.2147/TCRM.S86226. eCollection 2015.
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BACKGROUND
Seya MJ, Gelders SF, Achara OU, Milani B, Scholten WK. A first comparison between the consumption of and the need for opioid analgesics at country, regional, and global levels. J Pain Palliat Care Pharmacother. 2011;25(1):6-18. doi: 10.3109/15360288.2010.536307.
Reference Type
BACKGROUND
Duthey B, Scholten W. Adequacy of opioid analgesic consumption at country, global, and regional levels in 2010, its relationship with development level, and changes compared with 2006. J Pain Symptom Manage. 2014 Feb;47(2):283-97. doi: 10.1016/j.jpainsymman.2013.03.015. Epub 2013 Jul 17.
Reference Type
BACKGROUND
Chung SS, Park CK, Cho KJ, Choi KH, Kim JH, Kim SB, Kuh SU, Lee JC, Lee JH, Lee KY, Lee SH, Moon SH, Park SY, Shim JH, Son BC, Yoon MH, Park HJ. A Nationwide Retrospective Study of Opioid Management Patterns in 2,468 Patients with Spinal Pain in Korea. Asian Spine J. 2016 Dec;10(6):1122-1131. doi: 10.4184/asj.2016.10.6.1122. Epub 2016 Dec 8.
Reference Type
BACKGROUND
Centers For Disease Control And Prevention Public Health Service U S Department Of Health And Human Services. Guideline for Prescribing Opioids for Chronic Pain. J Pain Palliat Care Pharmacother. 2016 Jun;30(2):138-40. doi: 10.3109/15360288.2016.1173761.
Reference Type
BACKGROUND
Breivik H, Cherny N, Collett B, de Conno F, Filbet M, Foubert AJ, Cohen R, Dow L. Cancer-related pain: a pan-European survey of prevalence, treatment, and patient attitudes. Ann Oncol. 2009 Aug;20(8):1420-33. doi: 10.1093/annonc/mdp001. Epub 2009 Feb 24.
Reference Type
BACKGROUND
O'Brien T, Christrup LL, Drewes AM, Fallon MT, Kress HG, McQuay HJ, Mikus G, Morlion BJ, Perez-Cajaraville J, Pogatzki-Zahn E, Varrassi G, Wells JC. European Pain Federation position paper on appropriate opioid use in chronic pain management. Eur J Pain. 2017 Jan;21(1):3-19. doi: 10.1002/ejp.970.
Reference Type
BACKGROUND
Kwon JH, Hui D, Bruera E. A Pilot Study To Define Chemical Coping in Cancer Patients Using the Delphi Method. J Palliat Med. 2015 Aug;18(8):703-6. doi: 10.1089/jpm.2014.0446. Epub 2015 Apr 29.
Reference Type
BACKGROUND
Del Fabbro E. Assessment and management of chemical coping in patients with cancer. J Clin Oncol. 2014 Jun 1;32(16):1734-8. doi: 10.1200/JCO.2013.52.5170. Epub 2014 May 5.
Reference Type
BACKGROUND
Kwon JH, Tanco K, Park JC, Wong A, Seo L, Liu D, Chisholm G, Williams J, Hui D, Bruera E. Frequency, Predictors, and Medical Record Documentation of Chemical Coping Among Advanced Cancer Patients. Oncologist. 2015 Jun;20(6):692-7. doi: 10.1634/theoncologist.2015-0012. Epub 2015 May 1.
Reference Type
BACKGROUND
Rudd RA, Seth P, David F, Scholl L. Increases in Drug and Opioid-Involved Overdose Deaths - United States, 2010-2015. MMWR Morb Mortal Wkly Rep. 2016 Dec 30;65(50-51):1445-1452. doi: 10.15585/mmwr.mm655051e1.
Reference Type
BACKGROUND
Le Merrer J, Becker JA, Befort K, Kieffer BL. Reward processing by the opioid system in the brain. Physiol Rev. 2009 Oct;89(4):1379-412. doi: 10.1152/physrev.00005.2009.
Reference Type
BACKGROUND
Kirsh KL, Jass C, Bennett DS, Hagen JE, Passik SD. Initial development of a survey tool to detect issues of chemical coping in chronic pain patients. Palliat Support Care. 2007 Sep;5(3):219-26. doi: 10.1017/s1478951507000387.
Reference Type
BACKGROUND
Vowles KE, McEntee ML, Julnes PS, Frohe T, Ney JP, van der Goes DN. Rates of opioid misuse, abuse, and addiction in chronic pain: a systematic review and data synthesis. Pain. 2015 Apr;156(4):569-576. doi: 10.1097/01.j.pain.0000460357.01998.f1.
Reference Type
BACKGROUND
Voon P, Karamouzian M, Kerr T. Chronic pain and opioid misuse: a review of reviews. Subst Abuse Treat Prev Policy. 2017 Aug 15;12(1):36. doi: 10.1186/s13011-017-0120-7.
Reference Type
BACKGROUND
Chou R, Turner JA, Devine EB, Hansen RN, Sullivan SD, Blazina I, Dana T, Bougatsos C, Deyo RA. The effectiveness and risks of long-term opioid therapy for chronic pain: a systematic review for a National Institutes of Health Pathways to Prevention Workshop. Ann Intern Med. 2015 Feb 17;162(4):276-86. doi: 10.7326/M14-2559.
Reference Type
BACKGROUND
Green CR, Anderson KO, Baker TA, Campbell LC, Decker S, Fillingim RB, Kalauokalani DA, Lasch KE, Myers C, Tait RC, Todd KH, Vallerand AH. The unequal burden of pain: confronting racial and ethnic disparities in pain. Pain Med. 2003 Sep;4(3):277-94. doi: 10.1046/j.1526-4637.2003.03034.x.
Reference Type
BACKGROUND
Bannan S, Danby A, Cowan D, Ashraf S, Martin PG. Low heparinization with heparin-bonded bypass circuits: is it a safe strategy? Ann Thorac Surg. 1997 Mar;63(3):663-8. doi: 10.1016/s0003-4975(96)01054-5.
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BACKGROUND
Coleman JJ. The supply chain of medicinal controlled substances: addressing the Achilles heel of drug diversion. J Pain Palliat Care Pharmacother. 2012 Sep;26(3):233-50. doi: 10.3109/15360288.2012.703294.
Reference Type
BACKGROUND
Other Identifiers
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1702-020-829
Identifier Type: -
Identifier Source: org_study_id
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