Recruiting
Phase 1
Phase 2

Cannabidiol

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT06930703

Conditions

Sickle Cell Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cannabidiol

Placebo

Study Details

Brief summary:

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

Study ID

NCT06930703

Start date

Apr 3, 2025

Status verified date

Apr, 2025

Completion date

Feb 1, 2027

Anticipated

Primary completion date

Feb 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

52 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

Twice daily matching placebo

active comparator: Cannabidiol 200 mg

Twice daily 200 mg cannabidiol

active comparator: Cannabidiol 400 mg

Twice daily 400 mg cannabidiol

active comparator: Cannabidiol 600 mg

Twice daily 600 mg cannabidiol

Interventions

Cannabidiol

Cannabidiol (CBD) twice daily taken orally for 4-weeks

Placebo

Placebo equivalent twice daily taken orally for 4-weeks

Primary outcome measure

  • Tumor Necrosis Factor-alpha level [ Time Frame: at 4 weeks ]

Central Contacts and Locations

Central contacts

Susanna Curtis

212-241-3650susanna.curtis@mssm.edu

Locations

Icahn School of Medicine at Mount Sinai

Recruiting

Manhattan, New York, United States, 10029

Contacts

Susanna Curtis, MD, PhD

susanna.curtis@mssm.edu

Principal Investigator:

Susanna Curtis

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Jun 25, 2025

Last verified

Apr, 2025

Keywords

  • chronic pain
  • epidiolex
  • cannabidiol

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2025-06-25.