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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
Manhattan
Contact Information
Primary
Susanna Curtis
susanna.curtis@mssm.edu
212-241-3650
Time Frame
Start Date: 2025-04-03
Estimated Completion Date: 2027-02-01
Participants
Target number of participants: 52
Treatments
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
Sponsors
Leads: Icahn School of Medicine at Mount Sinai

This content was sourced from clinicaltrials.gov

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