A new clinical trial testing the safety and efficacy of dronabinol as a palliative agent in patients with sickle cell disease is now open.
The double-blind, randomized, phase 2 study will assess the effects of dronabinol in treating pain, inflammation, and other complications in patients with sickle cell disease.
The trial aims to recruit 60 participants, aged 18 years and above, at Mount Sinai Hospital in New York City, New York.
Participants will receive either dronabinol at a dose between 2.5 mg and 10 mg or a placebo twice a day for 8 weeks. The dose of dronabinol will be determined individually for each patient. On days 1 to 4 of the study, each patient’s dose will be titrated from 5 mg of dronabinol twice a day to a dose between 2.5 mg and 10 mg twice a day depending on patient preference.
Read more about the complications of sickle cell disease
The primary outcome measure of the study will be the change in the Patient Reported Measurement Outcome Information System (PROMIS) pain impact score. Secondary outcome measures will include the Adult Sickle Cell Quality of Life Information System (ASCQ-Me) pain impact score, quality of life outcomes, and markers of inflammation in the blood.
The trial is not yet recruiting participants. It is estimated to start in September 2022 and be completed by September 2025.
Dronabinol, also known as Marinol®, is an oral agent approved by the US Food and Drug Administration (FDA) that contains synthetic tetrahydrocannabinol. It is used to treat nausea and vomiting in patients undergoing chemotherapy and reduced appetite and weight loss in people with acquired immunodeficiency syndrome.
Sickle cell disease can be associated with severe acute or chronic pain due to sickle-shaped red blood cells obstructing blood flow, especially in small blood vessels.
Cannabinoids for the reduction of inflammation and sickle cell related pain (CRISP). ClinicalTrials.gov. August 29, 2022. Accessed August 30, 2022.