NCT05519111

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Sickle Cell Disease

Interventions

Type	Name	Description
DRUG	Dronabinol	Dronabinol, an FDA approval oral agent containing synthetic tetrahydrocannabinol (THC)
DRUG	Placebo	placebo equivalent

Timeline

• Start date: 2025-04-03
• Primary completion: 2027-04-01
• Completion: 2027-05-01
• First posted: 2022-08-29
• Last updated: 2025-10-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study