Buprenorphine for Cancer Pain

Phase 4

Recruiting

• Conditions: Cancer-Related Pain
• Interventions: Drug: Use of buprenorphine with FAO > 30 OME; Behavioral: CPM Rx application use

• Registration Number: NCT05910190
• Lead Sponsor: Fox Chase Cancer Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2022-08-10
• Study First Submitted: 2023-06-09
• Study First Submitted QC: 2023-06-09
• Study First Posted: 2023-06-18
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-06
• Last Update Posted: 2023-07-10
• Primary Completion: 2024-10-10
• Study Completion: 2024-10-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	CPM Rx application use	Receiving buprenorphine with short acting full agonist opioid with CPM Rx app to document medication use.
Intervention	Use of buprenorphine with FAO > 30 OME	Receiving buprenorphine with short acting full agonist opioid with CPM Rx app to document medication use.

Primary Outcome Measures

Name	Time	Method
Withdrawal while on Buprenorphine with Full Agonist Opioids	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	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.

Secondary Outcome Measures

Name	Time	Method
Usage of CPM Rx	3 months	Usage of the app will be monitored and described at the end of the study

Trial Locations

Locations (1)

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States