Dronabinol for the reduction of chronic pain and inflammation in people with sickle cell disease

Dr. Curtis seeks to become an independently funded investigator in sickle cell disease with a focus on the understanding and treatment of chronic pain. Chronic pain is a critical issue for people with sickle cell disease (SCD). This pain is primarily treated with opioids, but for many people with SCD opioids are inadequate to treat chronic pain alone. Cannabinoids (the primary active agents in marijuana) have been shown to be effective for chronic and neuropathic pain and reduce inflammation in non-SCD diseases. Inflammation in SCD is not only correlated with pain but is also correlated with high rates of end organ damage. Over one third of people with SCD say they use cannabis for pain relief, but there is currently no evidence to support this use. Further, there is no evidence to suggest what the adverse effects of this use might be for people with SCD. There are no guidelines for what doctors should tell patients with SCD who ask if cannabis products might help their pain. This proposal seeks to address this gap with a placebo-controlled, double-masked, 8 week-long study of dronabinol, an FDA approval oral agent which contains tetrahydrocannabinol (THC), the primary active ingredient in cannabis. The aims of this study are 1: To determine whether dronabinol will improve pain and QOL in adults with SCD and chronic pain, 2: To assess dronabinol's effect on markers of inflammation in patients with SCD compared to placebo, And 3: To determine the safety and tolerability of dronabinol use in adults with SCD compared to placebo. If dronabinol is found to improve chronic pain, or quality of life, or to reduce markers of inflammation, it should studied in a larger trial. Understanding the safety and tolerability of dronabinol will guide not only future studies but will help clinicians and patients understand some of the possible risks of cannabis use. Through this career development award Dr. Curtis will gain expertise in clinical trial design and execution, longitudinal data analysis and advanced modelling techniques, and clinical and translational aspects of the study of chronic pain. Her advisory committee consists of experts in clinical trial development, pain in SCD, inflammation in SCD, and statistics. Through working with a multidisciplinary mentorship team, the proposed research project, and formal coursework, Dr. Curtis will be able to become an independent clinical investigator with expertise in chronic pain treatment in sickle cell disease.