Piloting a Novel Therapeutic for Sleep Disturbance in Palliative Care Over 5 Weeks: The PILLOW Study
Theodore Brasky PhD
Summary
This clinical trial tests how well a cannabis gummy works in improving sleep and quality of life in patients with cancer. Many people with cancer (about 60%) have trouble sleeping, which can lower their quality of life. Sleep disturbance is defined as difficulty initiating or maintaining sleep, waking up earlier than desired and being unable to fall back to sleep, and excessive daytime sleepiness. In adults with cancer, sleep disturbance may be caused by multiple, often co-occurring factors including diagnosis, type, and stage of cancer, treatment regimen, physical complaints (e.g., pain), and psychological distress. Some patients use cannabis to help with sleep, but its effects are not well understood. Cannabis, which some people call marijuana, refers to the dried leaves, flowers, stems, and seeds of the cannabis sativa L plant. The plant contains at least 125 different cannabinoids, including delta-9 tetrahydrocannabinol (THC). Delta-9 THC is the most abundant form of THC in the cannabis plant. It has intoxicating effects, meaning it can temporarily alter a person's mood, thoughts, and perceptions (a "high"). This study will help researchers learn how cannabis affects sleep and quality of life compared to usual care.
Description
PRIMARY OBJECTIVE: I. To determine the safety and feasibility of a nightly cannabis gummy versus usual care among palliative care patients at the Ohio State University Comprehensive Cancer Center (OSUCCC). SECONDARY/EXPLORATORY OBJECTIVE: I. To examine the preliminary efficacy of a nightly cannabis gummy versus usual care on sleep disturbance and HRQOL among palliative care patients at the OSUCCC. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive a nightly dose of a cannabis-based gummy for 30 days on study. Patients also undergo blood sample collection on study. A…
Eligibility
- Age range
- 18+ years
- Sex