Clinical trial NCT06930703: Cannabidiol in Sickle Cell Disease
Official title: Treatment of Sickle Cell Pain and Inflammation With Cannabidiol (SPICe)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Sickle Cell Disease
Keywords: chronic pain
epidiolex
cannabidiol
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2025-04-16
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Twice daily cannabidiol given at 3 dose levels, 200mg, 400mg, and 600mg, for 4 weeks, with 1:1:1:1 allocation of placebo to 3 drug doses.
Primary purpose: OTHER

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.

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.

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

Primary outcomes:
measure: Tumor Necrosis Factor-alpha level
timeFrame: at 4 weeks
Secondary outcomes:
measure: Levels of Markers of Inflammation
timeFrame: at 4 weeks
measure: White Blood Cell with differential
timeFrame: at 4 weeks
measure: C-reactive protein level
timeFrame: at 4 weeks
measure: Tryptase levels
timeFrame: at 4 weeks
measure: Substance P levels
timeFrame: at 4 weeks
measure: Cytokines levels
timeFrame: at 4 weeks
measure: Adult Sickle Cell Quality of Life Measurement System
timeFrame: at 4 weeks
measure: Patient Reported Outcome Information System (PROMIS) to measure Pain
timeFrame: at 4 weeks
measure: Leeds Assessment of Neuropathic Symptoms and Signs pain scale (S-LANSS)
timeFrame: 4 weeks
measure: Patient Reported Outcomes Measurement Information System (PROMIS)
timeFrame: at 4 weeks
measure: Oral Morphine Equivalents (OME)
timeFrame: at 4 weeks
measure: Number of Emergency Room Visits
timeFrame: at 4 weeks
measure: Number of Hospital Admissions
timeFrame: at 4 weeks
measure: Number of Psychiatric Facility Utilizations
timeFrame: at 4 weeks
measure: Columbia-Suicide Severity Rating Scale - Severity and Intensity Subscale (C-SSRS SI)
timeFrame: at 4 weeks
measure: Prodromal Questionnaire - Brief Version (PQ-B)
timeFrame: at 4 weeks
Other outcomes:
Locations:
city: Manhattan
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Susanna Curtis
role: PRINCIPAL_INVESTIGATOR
References: