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临床试验/ACTRN12621000795897
ACTRN12621000795897
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A Pilot Randomised Controlled Trial of SMS Text Messages to Support Self-Tapering of Opioids for adults with Chronic Pain

Pain Management Research Institute, Faculty of Medicine & Health, The University of Sydney.0 个研究点目标入组 28 人2021年6月24日

概览

阶段
未知
干预措施
未指定
疾病 / 适应症
Chronic Pain
发起方
Pain Management Research Institute, Faculty of Medicine & Health, The University of Sydney.
入组人数
28
状态
已完成
最后更新
2年前

概览

简要总结

暂无简介。

注册库
who.int
开始日期
2021年6月24日
结束日期
2022年11月21日
最后更新
2年前
研究类型
Interventional
性别
All

研究者

发起方
Pain Management Research Institute, Faculty of Medicine & Health, The University of Sydney.

入排标准

入选标准

  • Age 18 years or older.
  • Diagnosed with a chronic (\> 3 months) pain condition according to the International Classification of Diseases \- 11th Revision.
  • Have been using opioid analgesics at a dose of at least 40 mg/day Oral Morphine Equivalent for at least four weeks (i.e. participants are likely to have developed a certain level of physical tolerance).35 36
  • Have been advised by a clinician to taper opioids.
  • Are voluntarily tapering opioid medications, as indicated by verbalised willingness and consent.
  • Be currently tapering or will be tapering their opioid medications at the time of enrolment. There is no restriction on how many times patients may have attempted opioid tapering, nor is there any restriction of the period of time participants may have been tapering before entering the study.
  • Able to understand written and spoken English.
  • Own a mobile phone that receives SMS.
  • Able to give written informed consent and comply with study procedures.

排除标准

  • Cognitive impairment or intellectual disability preventing adherence to the study procedure.
  • Evidence of severe opioid use disorder, based on the Diagnostic and Statistical Manual of Mental Disorders (DSM\-5\). Illicit substance use, including illicit opioid use, is not an exclusion criterion, however if it fits a wider pattern of symptoms indicating a severe opioid use disorder it may inform a decision that the participant is ineligible for the study.
  • History of primary psychotic disorder, bipolar affective disorder, bipolar disorder with psychotic features, depressive disorder with psychotic features, borderline personality disorder, antisocial personality disorder, or a positive family history (first degree relative) of psychotic disorder or bipolar affective disorder such that participants might be at more than low/negligible risk by participating in the study.
  • Any other major, poorly controlled medical or mental health comorbidity.
  • Participation in another clinical trial concurrently, since this will not constitute ‘usual care’ and can interfere with the study primary and secondary objectives by increasing the burden to patients and influencing estimates.

结局指标

主要结局

未指定

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