Addressing the Risks of Long-Term Opioid Therapy in Chronic Noncancer Pain

NCT03161795 | Completed DMC

• 1 other identifier: 1702-020-829
• Study Type: observational
• Target: 258
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Noncancer Pain; Opioid-Related Disorders

Keywords

Chemical coping; Long-term opioid therapy; Risk factors; Predictive tools; Frequency

Outcome Measures

Primary Outcomes (1)

• Frequency of opioid-related chemical coping

  Prevalence of chemical coping with opioids in the study population by the pain specialists participating in the study through a questionnaire that contained the per-protocol definition of chemical coping and seven different aberrant behaviors related to chemical coping proposed by a panel of experts. One or more affirmative answers were considered as "positive"

  The assessment took place during a routine outpatient clinic 1 day visit. The presence of chemical coping was evaluated by pain specialist through the questionnaire immediately after the routine visit of each patient.

Secondary Outcomes (3)

• Sociodemographic characteristics of chronic noncancer pain patients using long-term opioid therapy

  The data was collected from the start of the study up to 3 months after finishing recruitment. The NRS was assessed in each patient during the routine visit with a pain specialist.

• Characteristic of opioid's use in chronic noncancer pain in South Korea

  The data was collected from the start of the study up to 3 months after finishing recruitment.

• Risk factors associated to long-term opioid therapy and opioid-related chemical coping

  The patients answered to the questionnaires and tools before a routine 1 day visit. Each patient finished the evaluation on the same day of the visit. The record of answers will take place from the start to the finish of recruitment.

Eligibility Criteria

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

Study Population

The study was open-labeled, national, multicenter, observational, cohort study conducted at 8 Tertiary hospitals located in South Korea. The study population were patients with chronic noncancer pain receiving long-term opioid therapy and attending the outpatient pain clinic of any of the participant hospitals.

Sponsors & Collaborators

• Seoul National University: lead
• Seoul National University Bundang Hospital: collaborator
• Korea University Guro Hospital: collaborator
• Ewha Womans University: collaborator
• Ajou University School of Medicine: collaborator
• Konkuk University Hospital: collaborator
• Chung-Ang University Hosptial, Chung-Ang University College of Medicine: collaborator
• Seoul St. Mary's Hospital: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (21)

• 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.

  PMID: 27136641 BACKGROUND

• Kaplan JA, Richards-Waugh LL, Bailey KM, Kraner JC. Epidemic: fatal pharmaceutical abuse in West Virginia 1991-2008. W V Med J. 2010;106(4 Spec No):88-90. No abstract available.

  PMID: 21932761 BACKGROUND

• 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.

  PMID: 26357478 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.

  PMID: 21426212 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.

  PMID: 23870413 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.

  PMID: 27994790 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.

  PMID: 27301691 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.

  PMID: 19244085 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.

  PMID: 27991730 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.

  PMID: 25922879 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.

  PMID: 24799476 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.

  PMID: 25933929 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.

  PMID: 28033313 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.

  PMID: 19789384 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.

  PMID: 17969825 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.

  PMID: 25785523 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.

  PMID: 28810899 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.

  PMID: 25581257 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.

  PMID: 12974827 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.

  PMID: 9066381 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.

  PMID: 22973912 BACKGROUND

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Jee Y Moon, MD, PhD

  Seoul National University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 22, 2017
• Study Start: April 25, 2017
• Primary Completion: January 19, 2018
• Study Completion: March 12, 2018
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)