Cannabidiol (CBD) treatment for adults with sickle cell disease
Treatment of Sickle Cell Pain and Inflammation With Cannabidiol (SPICe)
This trial will try three doses of oral cannabidiol taken twice daily for 4 weeks in adults with sickle cell disease, compared with placebo, to see if it lowers inflammation and pain-related measures.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Drugs / interventions | crizanlizumab |
| Locations | 1 site (Manhattan, New York) |
| Trial ID | NCT06930703 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18 or older with a clinical diagnosis of sickle cell disease who are not currently in pain crisis, willing to abstain from cannabis during the treatment period, and have a cannabinoid-negative urine test within 30 days are the intended participants.
Not a fit: People who are pregnant or nursing, unable to stop cannabis use, have known cannabinoid intolerance, or who are in an active pain crisis are unlikely to be eligible or receive benefit from this short dose-finding trial.
Why it matters
Potential benefit: If successful, cannabidiol could offer a non-opioid option that reduces inflammation and pain interference for some adults with sickle cell disease.
How similar studies have performed: Cannabidiol has demonstrated benefit in other conditions like certain epilepsies, but evidence for reducing inflammation or chronic pain in sickle cell disease is limited, making this a relatively novel dose-finding effort.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Manhattan, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.