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 人开始时间: 2021年6月24日最近更新: 2023年9月26日

适应症

试验速览

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•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.

•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.

发起方

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