Cannabidiol (CBD) treatment for adults with sickle cell disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled dose-finding trial testing oral cannabidiol given twice daily at 200 mg, 400 mg, or 600 mg versus placebo for 4 weeks. Fifty-two adults with sickle cell disease who are not in an acute pain crisis and who have a negative urine cannabinoid test within 30 days will be randomized 1:1:1:1. The primary outcome is reduction in the inflammatory cytokine TNFα, with additional pain-related measures captured. Participants must be stable on any sickle cell–modifying therapies or home opioid regimens for at least 3 months prior to enrollment.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Principal investigator: Susanna Curtis — Icahn School of Medicine at Mount Sinai
• Study coordinator: Susanna Curtis
• Email: susanna.curtis@mssm.edu
• Phone: 212-241-3650

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• Virtual reality options to help with VOC pain in adults with SCD

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.