Clinical trial NCT05910190: Buprenorphine for Cancer Pain
Official title: Effective Use of Buprenorphine for Long-Acting Pain Relief in Combination With Short-Acting Full Agonist Opioids for Cancer Related Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Cancer-Related Pain
Keywords: Cancer Pain
buprenorphine
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective, single arm, open label
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 1. Age greater than or equal to 18 years
2. English speaking and able to understand and sign informed consent and HIPAA consent document.
3. The patient will have pain from any cause with a pain level greater than or equal to 4 on a visual analog scale.
4. The patient will be able to complete study assessments including use of the CPM app (requires Smart Phone)
5. Patients who may become pregnant are using adequate contraceptives.
6. Patient is on the combination of buprenorphine and full agonist opioid \> 30 mg oral morphine equivalent or being started on both buprenorphine and full agonist opioid \>30 mg oral morphine equivalent at the time of enrollment

Primary outcomes:
measure: Withdrawal while on Buprenorphine with Full Agonist Opioids
timeFrame: 3 months
measure: Maximum dose of FAO with Buprenorphine
timeFrame: 3 months
Secondary outcomes:
measure: Usage of CPM Rx
timeFrame: 3 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
References:
citation: Schmidt-Hansen M, Taubert M, Bromham N, Hilgart JS, Arnold S. The effectiveness of buprenorphine for treating cancer pain: an abridged Cochrane review. BMJ Support Palliat Care. 2016 Sep;6(3):292-306. doi: 10.1136/bmjspcare-2015-000939. Epub 2015 Dec 15.