Actively Recruiting
Cannabidiol in Sickle Cell Disease
Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-06-25
52
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Cannabidiol in Sickle Cell Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age >18 years
- Clinical diagnosis of sickle cell disease (HbSS, HbSC, HbS\u03b2+ Thal, HbS\u03b20Thal, HbS variants)
- Baseline score of 60 or lower on the ASCQ-Me 7-day pain interference domain
- Stable dose of sickle cell modifying therapy (hydroxyurea, regular blood transfusions, L-glutamine, voxelotor, crizanlizumab) for at least 3 months if applicable
- Stable opioid pain medication dose at home for at least 3 months if applicable
- One urine toxicology negative for cannabinoids within 30 days of randomization
- Willing to abstain from cannabis, medical and illicit, during study weeks 1 through 4
- Not pregnant or nursing
- If a woman capable of becoming pregnant, willing to use a medically accepted form of birth control during study participation
- Able to consent for research
You will not qualify if you...
- Known intolerance to cannabinoids
- History of psychotic episode, psychosis, or active suicidality
- Contraindication to epidiolex based on side effects, medications, or medical problems as evaluated by a physician
- Daily cannabis user
- Diagnosis of active substance use disorder
- ALT levels greater than 3 times the upper limit of normal
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Icahn School of Medicine at Mount Sinai
Manhattan, New York, United States, 10029
Actively Recruiting
Research Team
S
Susanna Curtis
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
4
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