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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

Sponsor: Icahn School of Medicine at Mount Sinai · Participants: 60 · Started: Apr 3, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT05519111

Locations in the U.S.

New YorkMount 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.