Cannabinoids for the Reduction of Inflammation and Sickle Cell Related Pain

Dronabinol for the Reduction of Chronic Pain and Inflammation in People With Sickle Cell Disease

A randomized, double blind, study of dronabinol as a palliative agent in the treatment of pain, inflammation, and other complications of sickle cell disease (SCD).

A randomized, double blind, study of dronabinol as a palliative agent in the treatment of pain, inflammation, and other complications of sickle cell disease (SCD).

Primary Objective: To determine whether dronabinol will improve pain and QOL in adults with SCD and chronic pain.

Secondary Objectives: To assess dronabinol's effect on markers of inflammation in patients with SCD compared to placebo.

To determine the safety and tolerability of dronabinol use in adults with SCD compared to placebo.

• Age >18 years
• Clinical diagnosis of SCD (HbSS, HbSC, HbSβ+; Thal, HbSβ0Thal, HbS variants)
• Baseline score of 60 or lower on the ASCQ-Me 7-day pain interference domain
• If on a SCD modifying therapy (hydroxyurea, regular blood transfusions, L-glutamine, voxelotor, crizanlizumab), on stable dose for at least 3 months
• If using opioids for pain at home, on stable dose for at least 3 months
• One urine toxicology negative for cannabinoids within 30 days of randomization
• No known intolerance to dronabinol, or marijuana
• No history of psychotic episode, psychosis, or active suicidality
• No contraindication to dronabinol with attention to potential side effects, concurrent medications/substances, and concurrent medical problems, as evaluated by a physician
• Willing to abstain from cannabis, medical and illicit, during study weeks 1 through 8
• Not pregnant or nursing
• If a woman capable of becoming pregnant, willing to use a medically accepted form of birth control for the duration of study participation. Accepted forms include oral contraception, medroxyprogesterone, contraceptive implants or patch, surgical sterilization, total abstinence.
• Able to consent for research
• No daily cannabis use
• No diagnosis of active substance use disorder