RecruitingPhase 2NCT05519111
Cannabinoids for the Reduction of Inflammation and Sickle Cell Related Pain
Dronabinol for the Reduction of Chronic Pain and Inflammation in People With Sickle Cell Disease
Sponsor
Icahn School of Medicine at Mount Sinai
Enrollment
60 participants
Start Date
Apr 3, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Min Age: 18 Years
Inclusion Criteria15
- 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
- No known intolerance to dronabinol, or marijuana
- No history of psychotic episode, psychosis, or active suicidality
- No contraindication to dronabinol with attention to potential side effects, concurrent medications/substances, and concurrent medical problems, as evaluated by a physician
- Willing to abstain from cannabis, medical and illicit, during study weeks 1 through 8
- 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
- No daily cannabis use
- No diagnosis of active substance use disorder
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Interventions
DRUGDronabinol
Dronabinol, an FDA approval oral agent containing synthetic tetrahydrocannabinol (THC)
DRUGPlacebo
placebo equivalent
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05519111
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