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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03161795
Recruitment Status : Completed
First Posted : May 22, 2017
Last Update Posted : June 28, 2018
Sponsor:
Collaborators:
Seoul National University Bundang Hospital
Korea University Guro Hospital
Ewha Womans University
Ajou University School of Medicine
Konkuk University Hospital
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Seoul St. Mary's Hospital
Information provided by (Responsible Party):
Jeeyoun Moon, Seoul National University

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.


Condition or disease
Chronic Noncancer Pain Opioid-Related Disorders

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Study Type : Observational [Patient Registry]
Actual Enrollment : 258 participants
Observational Model: Other
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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"


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.


Information from the National Library of Medicine

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


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University
Seoul National University Bundang Hospital
Korea University Guro Hospital
Ewha Womans University
Ajou University School of Medicine
Konkuk University Hospital
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Seoul St. Mary's Hospital
Investigators
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Study Director: Jee Y Moon, MD, PhD Seoul National University Hospital
Additional Information:
Publications:

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Responsible Party: Jeeyoun Moon, Clinical Associate Professor, Seoul National University
ClinicalTrials.gov Identifier: NCT03161795    
Other Study ID Numbers: H1702020829
First Posted: May 22, 2017    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jeeyoun Moon, Seoul National University:
Chemical coping
Long-term opioid therapy
Risk factors
Predictive tools
Frequency
Additional relevant MeSH terms:
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Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders