Status:
RECRUITING
Cannabidiol in Sickle Cell Disease
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 demons...
Eligibility Criteria
Inclusion
- 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
- 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 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
Exclusion
- No known intolerance to cannabinoids
- No history of psychotic episode, psychosis, or active suicidality
- No contraindication to epidiolex with attention to potential side effects, concurrent medications/substances, and concurrent medical problems, as evaluated by a physician
- Not a daily cannabis user
- No diagnosis of active substance use disorder
- No ALT\>3 times the upper limit of normal
Key Trial Info
Start Date :
April 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT06930703
Start Date
April 3 2025
End Date
February 1 2027
Last Update
June 25 2025
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
Manhattan, New York, United States, 10029