Sickle Cell DiseasePainDrugPhase 1, Phase 2
What this study is
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.
What's being tested
- Cannabidiol
Intervention · DRUG
Cannabidiol (CBD) twice daily taken orally for 4-weeks
- Placebo
Intervention · DRUG
Placebo equivalent twice daily taken orally for 4-weeks
Study details
- Official title
- Treatment of Sickle Cell Pain and Inflammation With Cannabidiol (SPICe)
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Conditions
- Sickle Cell Disease
- Enrolling
- 52 people
- Starts
- 2025-04-03
- Est. completion
- 2027-02-01
- Design
- Quadruple-blind, randomized, parallel groups, Phase 1, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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1
Study locations (1)
1 openIcahn School of Medicine at Mount Sinai
Manhattan, New York, United States
- Susanna Curtis, MD, PhD · Contactsusanna.curtis@mssm.edu
- Susanna Curtis · Principal investigator
Recruiting
Study team
Sponsor
Icahn School of Medicine at Mount Sinai
Study ID STUDY-24-00903
Principal investigator
Susanna Curtis
Icahn School of Medicine at Mount Sinai
Have questions? The contacts above can answer them before you apply.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.