Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2025-12-24 @ 3:41 PM
NCT ID:
NCT03661892
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT03661892
Study Brief:
Protocol Section:
NCT03661892