RECRUITING

Cannabidiol in Sickle Cell Disease

Description

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.

Conditions

Sickle Cell Disease
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Related Conditions:

Sickle Cell Disease

Study Overview

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Study Details

Study overview

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.

Treatment of Sickle Cell Pain and Inflammation With Cannabidiol (SPICe)

Cannabidiol in Sickle Cell Disease

Condition
Sickle Cell Disease
Intervention / Treatment

-

Contacts and Locations

Manhattan

Icahn School of Medicine at Mount Sinai, Manhattan, New York, United States, 10029

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Icahn School of Medicine at Mount Sinai,

Susanna Curtis, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

2027-02-01