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临床试验/NCT05910190
NCT05910190招募中4 期

Effective Use of Buprenorphine for Long-Acting Pain Relief in Combination With Short-Acting Full Agonist Opioids for Cancer Related Pain

Fox Chase Cancer Center1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年8月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
入组人数
50
试验地点
1
主要终点
Withdrawal while on Buprenorphine with Full Agonist Opioids

研究概览

简要总结

This study will evaluate patients on both buprenorphine and full agonist opioids (FAO) to assess for withdrawal symptoms. Patients will be evaluated by clinicians and using validated tools to assess for pain and withdrawal. At the same time, patients will use a CPM Rx application on their phone to track medication use.

详细描述

This prospective study will recruit patients with pain related to cancer or its treatment who are on buprenorphine in combination with a full agonist opioid where dose of the full agonist opioids (FAO) is > 30 mg OME per day. They will be provided a mobile application (CPM Rx) for reporting of pain level daily and at each as needed dose. Withdrawal will be assessed using a modified Clinical Opioid Withdrawal Scale (COWS) score and patients will be instructed to be aware of changes in these symptoms. They will also be followed in person at the initial visit, and at days 14, 28, 56 , and 84 with Brief Pain Inventory (BPI) and COWS scale to assess for pain or withdrawal and other reported side effects. Pill counts will be done on days 28, 56, and 84 to further assess medication usage. Nurses will check-in to complete BPI and ask about withdrawal symptoms at days 42 and 70. The study seeks to assess if patients on buprenorphine and FAO have withdrawal symptoms, what are the highest doses of buprenorphine and FAO tolerated, and assess usage of the CPM Rx app. Each patient will be followed on the study for 3 months, unless the choose or it is deemed appropriate to end sooner.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Intervention

Experimental

Receiving buprenorphine with short acting full agonist opioid with CPM Rx app to document medication use.

干预措施: Use of buprenorphine with FAO > 30 OME (Drug)

Intervention

Experimental

Receiving buprenorphine with short acting full agonist opioid with CPM Rx app to document medication use.

干预措施: CPM Rx application use (Behavioral)

结局指标

主要结局

Withdrawal while on Buprenorphine with Full Agonist Opioids

时间窗: 3 months

Patients will be assessed on days 0 (baseline), 14, 28, 42, 56, 70, and 84 to assess for withdrawal using the validated COWS tool in conjunction with clinical assessment.

Maximum dose of FAO with Buprenorphine

时间窗: 3 months

Doses of buprenorphine and FAO will be assessed on days 0 (baseline), 14, 28, 42, 56, 70, and 84 with maximum dose of FAO and associated does of buprenorphine and maximum dose of buprenorphine and associated dose of FAO determined at the end of the study.

次要结局

  • Usage of CPM Rx(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marcin Chwistek

Director of Supportive Oncology and Palliative Care Program

Fox Chase Cancer Center

研究点 (1)

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