Buprenorphine for Cancer Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-10

Study Completion Date

2024-10-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cancer-Related Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

prospective, single arm, open label

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention

Receiving buprenorphine with short acting full agonist opioid with CPM Rx app to document medication use.

Group Type EXPERIMENTAL

Use of buprenorphine with FAO > 30 OME

Intervention Type DRUG

Patients will receive buprenorphine with concurrent FAO \>30 OME and be assessed for withdrawal, pain, and other symptoms.

CPM Rx application use

Intervention Type BEHAVIORAL

The CPM Rx application is used on smart phones to allow patients to input time-stamped data about medication type, dosage, and pain score. This will allow analysis of trends in self-reported pain and optimal dosing patterns. Usage over three months will be assessed.

Interventions

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Use of buprenorphine with FAO > 30 OME

Patients will receive buprenorphine with concurrent FAO \>30 OME and be assessed for withdrawal, pain, and other symptoms.

Intervention Type DRUG

CPM Rx application use

The CPM Rx application is used on smart phones to allow patients to input time-stamped data about medication type, dosage, and pain score. This will allow analysis of trends in self-reported pain and optimal dosing patterns. Usage over three months will be assessed.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No