Dronabinol for the Reduction of Chronic Pain and Inflammation in People With Sickle Cell Disease
Icahn School of Medicine at Mount Sinai
Summary
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).
Description
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
* 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 *…
Interventions
- DrugDronabinol
Dronabinol, an FDA approval oral agent containing synthetic tetrahydrocannabinol (THC)
- DrugPlacebo
placebo equivalent
Location
- Mount Sinai HospitalNew York, New York