Pilot, Syndros, Decreasing Use of Opioids in Breast Cancer Subjects With Bone Mets

• Status: Completed
• Trial end date: 2021-04-26
• Target enrollment: 0
• Participant gender: All

Summary

In patients with cancer induced bone pain, addition of Syndros will improve pain relief and decrease opioid requirement.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Arizona
• Treatments: Analgesics, Opioid; Dronabinol

Criteria

Inclusion Criteria:

1. Be capable of understanding the investigational nature of the study and all pertinent aspects of the study

2. Be capable of signing and providing written consent in accordance with institutional and federal guidelines

3. Have metastatic breast cancer with bone metastases

4. Be willing and able to comply with scheduled visits, treatment plan, and follow up with research staff

5. Age ≥ 21 years

6. Must be on opioid therapy for bone pain for at least 4 weeks

Exclusion Criteria:

1. Have a known sensitivity to dronabinol or alcohol

2. Have a history of hypersensitivity reaction to alcohol

3. Using medical marijuana currently

4. Using Syndros for nausea or appetite stimulant

5. Receiving or have received disulfiram- or metronidazole- containing products within past 14 days

6. Are currently pregnant or are of child-bearing age and refuse to use adequate contraception

7. Have a history of psychiatric illness

8. Have a history of seizure disorders