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Recruiting NCT06930703

Cannabidiol in Sickle Cell Disease

Phase I / Phase II Interventional Sickle Cell Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cannabidiol, Placebo.
Who it may be relevant to
Registry conditions: Sickle Cell Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Detailed description

The researchers will conduct a randomized, double blind, placebo-controlled, study of cannabidiol in an oral formulation. Participants will be enrolled when they are not in pain crisis and have demonstrated a urine toxicology test free from cannabinoids in the past 30 days. The sample size will be 52 participants, aged ≥18, with 1:1:1:1 allocation of placebo to 3 drug doses. This is a dose finding study with a primary outcome of reduction of inflammatory cytokine TNFα.

Interventions

  • Drug Cannabidiol
    Cannabidiol (CBD) twice daily taken orally for 4-weeks
  • Drug Placebo
    Placebo equivalent twice daily taken orally for 4-weeks

Primary outcome measures

  • Tumor Necrosis Factor-alpha level [Time frame: at 4 weeks]
Secondary outcome measures (12)
  • Levels of Markers of Inflammation [Time frame: at 4 weeks]
  • White Blood Cell with differential [Time frame: at 4 weeks]
  • C-reactive protein level [Time frame: at 4 weeks]
  • Tryptase levels [Time frame: at 4 weeks]
  • Substance P levels [Time frame: at 4 weeks]
  • Cytokines levels [Time frame: at 4 weeks]
  • Adult Sickle Cell Quality of Life Measurement System [Time frame: at 4 weeks]
  • Patient Reported Outcome Information System (PROMIS) to measure Pain [Time frame: at 4 weeks]
  • Leeds Assessment of Neuropathic Symptoms and Signs pain scale (S-LANSS) [Time frame: 4 weeks]
  • Patient Reported Outcomes Measurement Information System (PROMIS) [Time frame: at 4 weeks]
  • Oral Morphine Equivalents (OME) [Time frame: at 4 weeks]
  • Number of Emergency Room Visits [Time frame: at 4 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Other

Study locations

United States · 1 center
  • Icahn School of Medicine at Mount Sinai — Manhattan

Identifiers

NCT: NCT06930703 · STUDY-24-00903 · IN123001222

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗