Cannabis for Palliative Care in Cancer: A Placebo-controlled Randomized Trial of Full Spectrum Hemp-derived CBD/THC

Primary Objective

Given the negative symptoms associated with cancer, palliative care, a broad term for the prevention and treatment of adverse effects that arise from a disease or its treatment, continues to be a focus of cancer related research. In recent years one of the most popular options for this has become cannabis. There has been in increase of cancer patients using cannabis for relief; specifically, to improve sleep problems, decrease pain, and cope with stress. However, variation in recreationally available products makes determining the efficacy of different cannabinoids like CBD and THC difficult, this has lead to a lack of clear recommendations for those seeking relief. As such, this study aims to examine the therapeutic benefits of cannabis through a rigorous placebo-controlled design. Study participants will be assigned to take one of three medications over the course of 8 weeks: a CBD only product, a CBD product that contains a small amount of THC, or a Hemp Seed Oil product that does not contain either. These products are a Food and Drug Administration (FDA) Investigational New Drug (IND).

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Description

This study involves a total of 4 visits over the course of 8 weeks. Most of the appointments will be conducted solely out of the Anschutz Health Sciences Building (AHSB) except for appointment 3; this appointment will start at your home in our mobile and will finish at AHSB. At each appointment you will complete blood draws, other physical measures, cognitive tasks, as well as survey questions about your health, thoughts and lifestyle. At the third appointment you will use your study medication.

Details
Age
Adult
Eligibility
You must be at least 25 years old, have a cancer diagnosis, be interested in using CBD to improve symptoms related to your cancer or its treatment, and not be a regular cannabis user.
Locations

Outpatient CTRC
University of Colorado, Boulder

Principal Investigator
Photograph of Angela Bryan

Angela Bryan

Study ID

Protocol Number: 23-0982

More information available at ClinicalTrials.gov: NCT06266611

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