NCT06930703

Cannabidiol in Sickle Cell Disease

Treatment of Sickle Cell Pain and Inflammation With Cannabidiol (SPICe)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Randomized, placebo-controlled, double masked, dose finding study of twice daily cannabidiol given at 3 dose levels, 200mg, 400mg, and 600mg, compared to placebo for 4 weeks.

Detailed description

The researchers will conduct a randomized, double blind, placebo-controlled, study of cannabidiol in an oral formulation. Participants will be enrolled when they are not in pain crisis and have demonstrated a urine toxicology test free from cannabinoids in the past 30 days. The sample size will be 52 participants, aged ≥18, with 1:1:1:1 allocation of placebo to 3 drug doses. This is a dose finding study with a primary outcome of reduction of inflammatory cytokine TNFα.

Conditions

• Sickle Cell Disease

Interventions

Type	Name	Description
DRUG	Cannabidiol	Cannabidiol (CBD) twice daily taken orally for 4-weeks
DRUG	Placebo	Placebo equivalent twice daily taken orally for 4-weeks

Timeline

• Start date: 2025-04-03
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2025-04-16
• Last updated: 2025-06-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study