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Cannabinoids for the Reduction of Inflammation and Sickle Cell Related Pain
RecruitingPhase 2
Dronabinol for the Reduction of Chronic Pain and Inflammation in People With Sickle Cell Disease
Who can join
Ages 18 and older · All sexes
Full eligibility 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 * 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
About the study
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).
What is being tested
- Dronabinol (drug)
- Placebo (drug)
Sponsor: Icahn School of Medicine at Mount Sinai · Participants: 60 · Started: Apr 3, 2025
Contact the study team
- Susanna Curtis, MD, PhD · Phone: 2036718154
Official record on ClinicalTrials.gov — NCT05519111
Locations in the U.S.
| New York | Mount Sinai Hospital, New York |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.