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Opioid Analgesic
Buprenorphine for Cancer Pain
Phase 4
Recruiting
Research Sponsored by Fox Chase Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age greater than or equal to 18 years
The patient will have pain from any cause with a pain level greater than or equal to 4 on a visual analog scale
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
Study Summary
This trial will evaluate patients taking buprenorphine and opioids to understand withdrawal symptoms and pain. Patients will be evaluated by clinicians and use an app to track medication use.
Who is the study for?
This trial is for adults over 18 who speak English and can consent, experiencing cancer pain rated at least 4 on a visual scale. They must be able to use a smartphone app for tracking medication and either are on or starting buprenorphine with opioids equivalent to more than 30 mg of oral morphine. Those who may become pregnant should be using contraception.Check my eligibility
What is being tested?
The study tests the combination of buprenorphine with strong painkillers (opioids) in patients with significant cancer pain, monitoring for withdrawal symptoms and effectiveness in pain management through clinician evaluations and an app that tracks medication usage.See study design
What are the potential side effects?
Possible side effects include symptoms of opioid withdrawal such as nausea, vomiting, diarrhea, muscle aches, fever, sweating, and insomnia. Buprenorphine itself may cause drowsiness, dizziness, constipation, headache or respiratory issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I experience pain at a level of 4 or higher.
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I am currently on or starting a specific pain medication regimen.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum dose of FAO with Buprenorphine
Withdrawal while on Buprenorphine with Full Agonist Opioids
Secondary outcome measures
Usage of CPM Rx
Trial Design
1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment2 Interventions
Receiving buprenorphine with short acting full agonist opioid with CPM Rx app to document medication use.
Find a Location
Who is running the clinical trial?
Fox Chase Cancer CenterLead Sponsor
227 Previous Clinical Trials
37,488 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I experience pain at a level of 4 or higher.I am currently on or starting a specific pain medication regimen.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How efficacious is Intervention for the safety of individuals?
"The safety of this particular intervention was rated a 3 due to the Phase 4 trial status, which confirms its approval."
Answered by AI
Is there still interest in participating in this research endeavor?
"Per the information located on clinicaltrials.gov, this trial is actively enrolling patients. It was first announced in August 2022 and had its details edited most recently in June 2023."
Answered by AI
How many individuals can volunteer for this experiment?
"Affirmative. Documents available on clinicaltrials.gov show that, following the initial posting of this trial on August 10th 2022, it is currently recruiting participants with 50 patients needed at a single location."
Answered by AI
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