Recruiting
Phase 1 / Phase 2
Cannabidiol in Sickle Cell Disease
About this study
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.
- Condition
- Sickle Cell Disease
- Tested
- Cannabidiol, Placebo
- Sponsor
- Icahn School of Medicine at Mount Sinai
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 11
- Minimum age: 18 years
- Study condition: Sickle Cell Disease
- 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 6
- 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
1 site, 1 recruiting
Icahn School of Medicine at Mount Sinai
Manhattan, New York, United States
Contact
-
Susanna Curtis
212-241-3650 susanna.curtis@mssm.edu
Potential match only. Final eligibility is determined by the study team.