Cannabidiol in Sickle Cell Disease (SPICE)

Mount Sinai Health System

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Sickle Cell Disease

Treatments: Drug: Placebo; Drug: Cannabidiol

Study type: Interventional

Funder types: Other

Identifiers

NCT06930703

IN123001222 (Other Grant/Funding Number)

STUDY-24-00903

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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52 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Twice daily matching placebo

Treatment:

Drug: Placebo

Cannabidiol 200 mg

Active Comparator group

Description:

Twice daily 200 mg cannabidiol

Treatment:

Drug: Cannabidiol

Cannabidiol 400 mg

Active Comparator group

Description:

Twice daily 400 mg cannabidiol

Treatment:

Drug: Cannabidiol

Cannabidiol 600 mg

Active Comparator group

Description:

Twice daily 600 mg cannabidiol

Treatment:

Drug: Cannabidiol