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

Completed · Early Phase 1

Conditions studied: Bone Metastases, Breast Cancer, Pain

In brief

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

Key facts

Study ID

NCT03661892

Run by

University of Arizona

People needed

14

Starts

2018-12-19

Expected to finish

2021-04-26

Last updated by the study team

2021-04-29

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Be capable of understanding the investigational nature of the study and all pertinent aspects of the study
• Be capable of signing and providing written consent in accordance with institutional and federal guidelines
• Have metastatic breast cancer with bone metastases
• Be willing and able to comply with scheduled visits, treatment plan, and follow up with research staff
• Age ≥ 21 years
• Must be on opioid therapy for bone pain for at least 4 weeks

You may not qualify if…

• Have a known sensitivity to dronabinol or alcohol
• Have a history of hypersensitivity reaction to alcohol
• Using medical marijuana currently
• Using Syndros for nausea or appetite stimulant
• Receiving or have received disulfiram- or metronidazole- containing products within past 14 days
• Are currently pregnant or are of child-bearing age and refuse to use adequate contraception
• Have a history of psychiatric illness
• Have a history of seizure disorders

Where it is running

• University of Arizona — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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