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Taking people in United StatesPhase 1/2

Testing Cannabidiol for Pain in Sickle Cell Disease

Tests cannabidiol against a placebo in adults with sickle cell disease.

Key facts

Who runs it
Icahn School of Medicine at Mount Sinai
Where
Manhattan, United StatesSee the site
Trial code
Registry title
Cannabidiol in Sickle Cell Disease
Status
Recruiting
Phase
Phase 1/2
People taking part
52 people, planned
Started
3 Apr 2025
Expected to end
1 Feb 2027
Type of study
Interventional, 4 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Cannabidiol
  • Placebo
Record updated
25 June 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with sickle cell disease and ongoing pain. It tests cannabidiol against placebo for 4 weeks.

Age
Over 18 years.
Sex
All sexes can join.
Disease stage
Clinical diagnosis of sickle cell disease (HbSS, HbSC, HbSβ+ thalassemia, HbSβ0 thalassemia, or HbS variants). Baseline score of 60 or lower on the ASCQ-Me 7-day pain interference domain.
Earlier treatment
If taking a sickle cell therapy (hydroxyurea, regular blood transfusions, L-glutamine, voxelotor, crizanlizumab) or opioids for pain at home, the dose must be stable for at least 3 months.
Biomarker or test result
One urine test negative for cannabinoids within 30 days of randomization.

Main reasons for not taking part

  • Known intolerance to cannabinoids
  • History of psychotic episode, psychosis, or active suicidality
  • Daily cannabis use
  • Active substance use disorder
  • ALT more than 3 times the upper limit of normal

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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 cannot take part

  • No contraindication to epidiolex with attention to potential side effects, concurrent medications/substances, and concurrent medical problems, as evaluated by a physician
  • No history of psychotic episode, psychosis, or active suicidality
  • No diagnosis of active substance use disorder
  • No ALT>3 times the upper limit of normal
  • No known intolerance to cannabinoids
  • Not a daily cannabis user

Where in United States

  • Icahn School of Medicine at Mount SinaiManhattan, United StatesContact: Susanna Curtis, MD, PhDTaking people

About the trial

What the trial wants to find out

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.

The 4 groups in the trial

  • PlaceboPlacebo, for comparison

    Twice daily matching placebo

  • Cannabidiol 200 mgExisting treatment, for comparison

    Twice daily 200 mg cannabidiol

    Treatment: Cannabidiol

  • Cannabidiol 400 mgExisting treatment, for comparison

    Twice daily 400 mg cannabidiol

    Treatment: Cannabidiol

  • Cannabidiol 600 mgExisting treatment, for comparison

    Twice daily 600 mg cannabidiol

    Treatment: Cannabidiol

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Treatment of Sickle Cell Pain and Inflammation With Cannabidiol (SPICe)
Plain-language title
Testing Cannabidiol for Pain in Sickle Cell DiseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
25 June 2025