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

This a prospective single arm study enrolling patients with bone metastases from breast
cancer who have been on opioid therapy for bone pain for at least 4 weeks. All patients start
on Syndros at 4.2 mg po BID for 3 days, if tolerated without side effects the dose is
increased to 8.4 mg QAM and 4.2 mg QPM for an additional 3 days. If the patient continues to
tolerate the medication, the dose will be increased to 8.4 mg BID for the rest of the study
period (total of 8wks). For patients who have side effects secondary to Sydnros, the dose
will be decreased. Side effect assessment will be done by the research team 2 days after
making the dose adjustment. If subject continues to have side effects, dose will be held
until resolution of symptoms. If the study medicine is held for more than a week
continuously, they will be taken off the study. In addition, they will have baseline blood
and urine collected for biomarkers and also complete study related questionnaires (for
secondary end points). They are also provided an opioid drug diary which they will take home
during visit 1 to record their opioid pain medication use. Research staff will be calling
patients on a weekly basis to reinforce opioid drug diary, assess for Syndros side effect,
and adjust dose of Syndros. At the end of 8 weeks blood and urine is collected again and they
will complete the study questionnaires.

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