Actively Recruiting
Cannabinoids for the Reduction of Inflammation and Sickle Cell Related Pain
Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-10-02
60
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
Sponsors
I
Icahn School of Medicine at Mount Sinai
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
A randomized, double blind, study of dronabinol as a palliative agent in the treatment of pain, inflammation, and other complications of sickle cell disease (SCD).
CONDITIONS
Official Title
Cannabinoids for the Reduction of Inflammation and Sickle Cell Related Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age >18 years
- Clinical diagnosis of sickle cell disease (including HbSS, HbSC, HbSβ+ Thal, HbSβ0Thal, HbS variants)
- Baseline ASCQ-Me 7-day pain interference score of 60 or lower
- Stable dose of sickle cell modifying therapy (hydroxyurea, regular blood transfusions, L-glutamine, voxelotor, crizanlizumab) for at least 3 months if applicable
- Stable dose of opioids for pain at home for at least 3 months if applicable
- One urine toxicology test negative for cannabinoids within 30 days before randomization
- No known intolerance to dronabinol or marijuana
- No history of psychotic episodes, psychosis, or active suicidality
- No contraindications to dronabinol as evaluated by a physician
- Willingness to abstain from cannabis use during study weeks 1 through 8
- Not pregnant or nursing
- Women capable of pregnancy must use an accepted birth control method during study participation
- Able to provide informed consent
- No daily cannabis use
- No diagnosis of active substance use disorder
You will not qualify if you...
- History of psychotic episode, psychosis, or active suicidality
- Known intolerance to dronabinol or marijuana
- Contraindications to dronabinol based on side effects, current medications, or medical problems
- Daily cannabis use
- Active substance use disorder
- Pregnancy or nursing
- Unwillingness to abstain from cannabis during the study period
- Inability to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
Research Team
S
Susanna Curtis, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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