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Cannabidiol in Sickle Cell Disease
RecruitingPhase 1/2
Treatment of Sickle Cell Pain and Inflammation With Cannabidiol (SPICe)
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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
About the study
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.
What is being tested
- Cannabidiol (drug)
- Placebo (drug)
Sponsor: Icahn School of Medicine at Mount Sinai · Participants: 52 · Started: Apr 3, 2025
Contact the study team
- Susanna Curtis · Phone: 212-241-3650
Official record on ClinicalTrials.gov — NCT06930703
Locations in the U.S.
| New York | Icahn School of Medicine at Mount Sinai, Manhattan |
Conditions
From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.