RECRUITINGPhase 1 / Phase 2INTERVENTIONAL
Cannabidiol in Sickle Cell Disease
Treatment of Sickle Cell Pain and Inflammation With Cannabidiol (SPICe)
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
Cannabidiol
Cannabidiol (CBD) twice daily taken orally for 4-weeks
DRUG
Placebo
Placebo equivalent twice daily taken orally for 4-weeks
Locations (1)
Icahn School of Medicine at Mount Sinai
Manhattan, New York, United States