NCT06930703 Cannabidiol in Sickle Cell Disease
| NCT ID | NCT06930703 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | Sickle Cell Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 52 participants |
| Start Date | 2025-04-03 |
| Primary Completion | 2027-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 52 participants in total. It began in 2025-04-03 with a primary completion date of 2027-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Susanna Curtis
PRINCIPAL INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Frequently Asked Questions
Who can join the NCT06930703 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sickle Cell Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06930703 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06930703 currently recruiting?
Yes, NCT06930703 is actively recruiting participants. Contact the research team at susanna.curtis@mssm.edu for enrollment information.
Where is the NCT06930703 trial being conducted?
This trial is being conducted at Manhattan, United States.
Who is sponsoring the NCT06930703 clinical trial?
NCT06930703 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is Susanna Curtis at Icahn School of Medicine at Mount Sinai. The trial plans to enroll 52 participants.
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