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临床试验/NCT06084520
NCT06084520招募中不适用

Translation and Validation of the COMM and ASI-SR - Instruments for Assessing Substance Use Disorder Development in a Swedish Population of Patients With Long-term Pain Treated With Opioids

Uppsala University1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2023年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
400
试验地点
1
主要终点
COMM - Current opioid misuse version Swedish version

研究概览

简要总结

The goal of this observational study is to translate the COMM (Current opinion misuse measure) form and validate it using the ASI-SR (Addiction severity score-self report)in a Swedish population of pain patients treated with opioids. The secondary aim is to investigate acceptability of the instrument in a Swedish population of pain patients with long-term opioid treatment (LOT).

The tertiary aim is to investigate the prevalence of alcohol and illicit substance use in a Swedish population of pain patients with LOT.

详细描述

There is no validated instrument for the assessment of early detection of substance use disorder development in swedish language.

In order to address this gap, investigators plan to translate and validate the COMM questionnaire using the ASI-SR in a Swedish population of pain patients undergoing opioid treatment. In addition, study will investigate the prevalence of illicit substance use in this population and compare it to patients who are not receiving opioid treatment. The collection of material (blood) in the Uppsala Biobank for future analysis of neurobiological processes during long-term pain treatment will be performed.

Phase 1:

Translation of the instrument takes place according to the "Patient-Reported Outcome (PRO) Consortium translation process guidelines"and according to guidelines from the company MAPI ResearchTrust, which owns the rights to use of the instrument.

Phase 2: The subsequent phase entails validating the COMM instrument against the ASI-SR in a Swedish sample of patients experiencing long-term pain, in accordance with the "Cosmin guidelines" [40], and involves the following procedures. Firstly, the reliability of the COMM instrument by examining internal consistency, test-retest consistency, standard error of measurement (SEM), and conducting factor analysis with rotation in a Swedish population of patients with long-term pain andlong-term opioid treatment (LOT)will be assessed. Secondly, validity of the COMM instrument with regard to comprehensiveness, scope, user-friendliness, and predictability within this particular population will be investigated. Furthermore, investigators will assess the acceptability of the instrument among the study population. Finally, exploration of the prevalence of substance use alongside LOT in pain patients and compare it with pain patients who do not receive opioid treatment will be performed. Inclusion goal is to recruit 200 research subjects from various healthcare settings, including primary care, specialized pain care, other specialized care (e.g., Endometriosis Center), and addiction care (addiction medicine program for pain patients) for the test group. Additionally, 200 individuals are planned to be recruited from pain centers and primary care for the control group to measure prevalence rates. The control group will consist of patients with long-term pain who are not undergoing opioid treatment. Since the study involves two groups of patients with long-term pain (with and without opioid treatment), research group will inquire separately if participants are willing to provide blood samples for biomarker analysis of pain (O-link panel) and genetic analysis, which will be stored in the biobank for future research on the effects of opioids.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Intervention group:
  • Patients with long-term, non-cancer-related pain (>3 months) at least 3 days a week
  • opioid treatment for at least 1 month during last 6 months
  • age 18-75 years
  • fluent in spoken and written Swedish.
  • Control group:
  • Patients with long-term, non-cancer-related pain (>3 months) at least 3 days a week
  • no opioid treatment at inclusion and during last 3 months
  • age 18-75 years
  • fluent in spoken and written Swedish

排除标准

  • ongoing diseases or conditions that prevents the patient from completing to the study according to the doctor's assessment
  • serious cognitive disorder that makes answering the questions impossible. - - ongoing or treated cancer in the last 10 years
  • Insufficient knowledge of Swedish

结局指标

主要结局

COMM - Current opioid misuse version Swedish version

时间窗: Baseline

COMM is based on 17 questions, all of which are answered on a 5-point Likert scale. As the original COMM instrument has identified 5 categories of questions, each area will be assessed against the following instruments: 1. Symptoms and signs of drug abuse (question 1) - AUDIT, DUDIT, ASI-SR, drug and alcohol test 2. Emotional and psychiatric problems (questions 2,5,7,8,13) - ASI-SR, GAD-7, PHQ9 3. Visitor characteristics/patterns (questions 3,12,17) - medical record data 4. Occurrence of untrue statement (doubt/lie/untruth) and drug use (questions 4,6,9,10,11) - medical record data, drug and alcohol tests

次要结局

  • Patient Health Questionnaire PHQ9(Baseline)
  • PETh - Phosphatidylethanol in blood(baseline)
  • ASI-SR Addiction severity index - short release(Baseline)
  • COMM - 2nd test(1 week after baseline)
  • AUDIT Alcohol Use Disorder Identification Test(Baseline)
  • Generalized anxiety disorder (GAD-7)[(baseline)
  • BPI-Brief Pain Inventory - short form(Baseline)
  • Drug Use Disorder Identification Test (DUDIT)(Baseline)
  • Drug detection test - saliva(baseline)
  • Patient global impression of change - PGI-C(Baseline)
  • Cannabis in DBS ( Dry blood spott)(baseline)

研究者

发起方
Uppsala University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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