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RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

Cannabidiol in Sickle Cell Disease

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Cannabidiol

Cannabidiol (CBD) twice daily taken orally for 4-weeks

DRUG

Placebo

Placebo equivalent twice daily taken orally for 4-weeks

Locations (1)

Icahn School of Medicine at Mount Sinai
Manhattan, New York, United States