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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
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

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.
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.
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 below
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I am 18 years old or older.
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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 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum dose of FAO with Buprenorphine
Withdrawal while on Buprenorphine with Full Agonist Opioids
Secondary study objectives
Usage of CPM Rx

Awards & Highlights

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.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
234 Previous Clinical Trials
39,323 Total Patients Enrolled

Media Library

Buprenorphine (Opioid Analgesic) Clinical Trial Eligibility Overview. Trial Name: NCT05910190 — Phase 4
Cancer Pain Research Study Groups: Intervention
Cancer Pain Clinical Trial 2023: Buprenorphine Highlights & Side Effects. Trial Name: NCT05910190 — Phase 4
Buprenorphine (Opioid Analgesic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05910190 — Phase 4
~15 spots leftby Dec 2025
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