RECRUITING

Cannabidiol in Sickle Cell Disease

Talk to us

Conditions

Sickle Cell Diseasechronic painepidiolexcannabidiol

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-04-03
Study Completion:2027-02-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06930703

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \>18 years
  2. * Clinical diagnosis of SCD (HbSS, HbSC, HbSβ+; Thal, HbSβ0Thal, HbS variants)
  3. * Baseline score of 60 or lower on the ASCQ-Me 7-day pain interference domain
  4. * If on a SCD modifying therapy (hydroxyurea, regular blood transfusions, L-glutamine, voxelotor, crizanlizumab), on stable dose for at least 3 months
  5. * If using opioids for pain at home, on stable dose for at least 3 months
  6. * One urine toxicology negative for cannabinoids within 30 days of randomization
  7. * Willing to abstain from cannabis, medical and illicit, during study weeks 1 through 4 • Not pregnant or nursing
  8. * 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.
  9. * Able to consent for research
  1. * No known intolerance to cannabinoids
  2. * No history of psychotic episode, psychosis, or active suicidality
  3. * No contraindication to epidiolex with attention to potential side effects, concurrent medications/substances, and concurrent medical problems, as evaluated by a physician
  4. * Not a daily cannabis user
  5. * No diagnosis of active substance use disorder
  6. * No ALT\>3 times the upper limit of normal

Contacts and Locations

Study Contact

Susanna Curtis
CONTACT
212-241-3650
susanna.curtis@mssm.edu

Principal Investigator

Susanna Curtis
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-03
Study Completion Date2027-02-01

Study Record Updates

Study Start Date2025-04-03
Study Completion Date2027-02-01

Terms related to this study

Keywords Provided by Researchers

  • chronic pain
  • epidiolex
  • cannabidiol

Additional Relevant MeSH Terms

  • Sickle Cell Disease