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โ† Trials
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Cannabidiol in Sickle Cell Disease

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllIcahn School of Medicine at Mount Sinai
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age \>18 years * Clinical diagnosis of SCD (HbSS, HbSC, HbSฮฒ+; Thal, HbSฮฒ0Thal, 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 โ€ข 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
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What it tests

  • Cannabidiol
  • Placebo
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Where

1 site
Icahn School of Medicine at Mount Sinai
Manhattan, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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