Recruiting

Buprenorphine

Sponsor:

Fox Chase Cancer Center

Code:

NCT05910190

Conditions

Cancer-Related Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Use of buprenorphine with FAO > 30 OME

CPM Rx application use

Study Details

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.

Conditions

Cancer-Related Pain

Study ID

NCT05910190

Start date

Aug 10, 2022

Status verified date

Jul, 2023

Completion date

Oct 10, 2024

Anticipated

Primary completion date

Oct 10, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Intervention

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

Interventions

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.

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.

Primary outcome measure

  • Withdrawal while on Buprenorphine with Full Agonist Opioids [ Time Frame: 3 months ]
  • Maximum dose of FAO with Buprenorphine [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Marcin Chwistek, MD

215-728-8080Marcin.Chwistek@fccc.edu

Dylan Sherry, MD

215-728-8080Dylan.Sherry@fccc.edu

Locations

Fox Chase Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19111

Contacts

Marcin Chwistek, MD

215-728-8080Marcin.Chwistek@fccc.edu

More Information

Sponsor

Fox Chase Cancer Center

Last update posted

Jul 10, 2023

Last verified

Jul, 2023

Keywords

  • Cancer Pain
  • buprenorphine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Fox Chase Cancer Center on 2023-07-10.