Buprenorphine for Cancer Pain

NCT05910190 | Unknown Phase 4 FDA Drug

• 1 other identifier: 21-1060
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Cancer Pain; buprenorphine

Outcome Measures

Primary Outcomes (2)

• Withdrawal while on Buprenorphine with Full Agonist Opioids

  Patients will be assessed on days 0 (baseline), 14, 28, 42, 56, 70, and 84 to assess for withdrawal using the validated COWS tool in conjunction with clinical assessment.

  3 months

• Maximum dose of FAO with Buprenorphine

  Doses of buprenorphine and FAO will be assessed on days 0 (baseline), 14, 28, 42, 56, 70, and 84 with maximum dose of FAO and associated does of buprenorphine and maximum dose of buprenorphine and associated dose of FAO determined at the end of the study.

  3 months

Secondary Outcomes (1)

• Usage of CPM Rx

  3 months

Study Arms (1)

Intervention

EXPERIMENTAL

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

Drug: Use of buprenorphine with FAO > 30 OME; Behavioral: CPM Rx application use

Interventions

Use of buprenorphine with FAO > 30 OME DRUG

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

Intervention

CPM Rx application use 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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Fox Chase Cancer Center: lead

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 26669324 BACKGROUND

MeSH Terms

Conditions

Cancer Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Marcin Chwistek, MD

CONTACT

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

Dylan Sherry, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Supportive Oncology and Palliative Care Program

Model Details: prospective, single arm, open label

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: June 18, 2023
• Study Start: August 10, 2022
• Primary Completion: October 10, 2024
• Study Completion: October 10, 2024
• Last Updated: July 10, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)