RCT of CBD for Anxiety in Advanced Breast Cancer

Summary

Participation Requirements

Description

This is a randomized, double-blind, placebo-controlled trial of a single dose of CBD for acute anticipatory anxiety in patients with advanced breast cancer undergoing computed tomography (CT) scan to assess tumor burden. The research study investigates use of CBD to manage anxiety prior to an oncolo...

This is a randomized, double-blind, placebo-controlled trial of a single dose of CBD for acute anticipatory anxiety in patients with advanced breast cancer undergoing computed tomography (CT) scan to assess tumor burden. The research study investigates use of CBD to manage anxiety prior to an oncologic imaging scan. CBD is a component of the cannabis sativa (marijuana) plant and of hemp. Studies of CBD have led to its approval by the Food and Drug Administration for certain childhood seizure disorders. Researchers have also been studying the use of CBD to manage anxiety and pain. This study is designed to find out if the drug can help reduce anxiety and can safely be given to participants with advanced breast cancer who are scheduled for a CT scan. After screening procedures confirm participation in the research study, participants will be "randomized" into one of two study groups: one group will receive CBD, the other group will receive a placebo of flavored corn syrup. Randomization means that participants are put into a group by chance. Neither the participant nor the research team will choose participant group assignment. Participants will have a 66% chance of receiving a single dose of CBD. Participants will have a 33% chance of receiving a single dose of placebo. On the day of scheduled CT scans, participants will complete questionnaires before and after receiving a single dose of CBD or placebo then undergo computed tomography (CT) scan. Participants will be contacted by phone approximately a week later and interviewed about study drug consumption and the CT scan experience. This study is supported by funding from the Hans and Mavis Lopater Foundation. Approximately 50 people are anticipated to take part in this study. This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. The FDA (the U.S. Food and Drug Administration) has not approved CBD to manage anxiety but it has been approved for use in children with some seizure disorders.

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