RecruitingPhase 1Phase 2NCT06930703

Cannabidiol in Sickle Cell Disease

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

Sponsor

Icahn School of Medicine at Mount Sinai

Enrollment

52 participants

Start Date

Apr 3, 2025

Study Type

INTERVENTIONAL

Conditions

Sickle Cell Disease

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria9

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 Criteria6

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