NCT06930703RecruitingPhase 1/2
Cannabidiol in Sickle Cell Disease
Treatment of Sickle Cell Pain and Inflammation With Cannabidiol (SPICe)
Source: ClinicalTrials.gov · Last updated 25 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 52 (estimated)
- First submitted
- 9 Apr 2025
- Start date
- 3 Apr 2025
- Primary completion date
- 1 Feb 2027
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Diseases
- Sickle cell disease
- NCT number
- NCT06930703
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 52
- From 3 Apr 2025 to the primary completion date, 1 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- No contraindication to epidiolex with attention to potential side effects, concurrent medications/substances, and concurrent medical problems, as evaluated by a physician
Other illness
- No history of psychotic episode, psychosis, or active suicidality
- No diagnosis of active substance use disorder
Lab values
- No ALT\>3 times the upper limit of normal
Other
- No known intolerance to cannabinoids
- Not a daily cannabis user
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | Manhattan | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.