Ignite Creation Date:
2024-05-06 @ 7:10 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05910190
Status:
RECRUITING
Last Update Posted:
2023-07-10
First Post:
2023-06-09
Brief Title:
Buprenorphine for Cancer Pain
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
Effective Use of Buprenorphine for Long-Acting Pain Relief in Combination With Short-Acting Full Agonist Opioids for Cancer Related Pain
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None