Addressing the Risks of Long-Term Opioid Therapy in Chronic Noncancer Pain
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|ClinicalTrials.gov Identifier: NCT03161795|
Recruitment Status : Completed
First Posted : May 22, 2017
Last Update Posted : June 28, 2018
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.
|Condition or disease|
|Chronic Noncancer Pain Opioid-Related Disorders|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||258 participants|
|Target Follow-Up Duration:||3 Months|
|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|
|Actual Study Start Date :||April 25, 2017|
|Actual Primary Completion Date :||January 19, 2018|
|Actual Study Completion Date :||March 12, 2018|
- Frequency of opioid-related chemical coping [ Time Frame: 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. ]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"
- Sociodemographic characteristics of chronic noncancer pain patients using long-term opioid therapy [ Time Frame: 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. ]Patients' demographic data (sex, age, ethnicity, body mass index, marital status, education, and employment status), pain characteristics [duration, intensity using an 11-pointed numerical rating pain scale (NRS) score ranged from 0 (no pain) to 10 (pain as bad as you can imagine), etiology, location, and type of pain such as nociceptive, neuropathic, functional pain syndrome (fibromyalgia, temporomandibular disorder, etc.), and mixed, co-morbid psychiatric disease, substance abuse history, secondary morbid gain, ongoing litigation, history of taken prescription drugs with alcohol, and suicidal ideation] were collected.
- Characteristic of opioid's use in chronic noncancer pain in South Korea [ Time Frame: The data was collected from the start of the study up to 3 months after finishing recruitment. ]Opioid information including duration of administration, opioid types (long-acting vs. short-acting), route of administration (oral, transdermal, mucosal, or intravenous), Morphine Equivalent Daily Dosage (MEDD, mg/day), the initial prescriber, number of visits per year to an opioid prescriber, and history of Emergency room (ER) visits seeking for opioids, as well as concomitant use of benzodiazepines and other medication such as antidepressants, anticonvulsants, and/or topical agents were obtained.
- Risk factors associated to long-term opioid therapy and opioid-related chemical coping [ Time Frame: 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. ]The assessment was conducted through a survey in the outpatient setting of each pain clinic. The survey contained a number of questionnaires including 1) the Cut, Annoyed, Guilty, Eye-opener - Adapted to Include Drugs (CAGE-AID); 2) the Brief Pain Inventory-Short Form (BPI-SF); 3) Pain Catastrophizing Scale; 4) Hospital Anxiety and Depression Scale (HADS); 5) Insomnia Severity Index (ISI); 6) Korean Instrumental Activities of Daily Living Scale (K-IADL); 7) Korean-Connor-Davidson Resilience Scale (K-CD-RISC); and 8) Patient Global Impression of Change Scale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03161795
|Korea, Republic of|
|Seoul National University Hospital|
|Seoul, Korea, Republic of|
|Study Director:||Jee Y Moon, MD, PhD||Seoul National University Hospital|