Using cannabinoids to reduce inflammation and pain in sickle cell disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of dronabinol, a cannabinoid, as a palliative treatment for adults suffering from sickle cell disease (SCD) and chronic pain. It is a randomized, double-blind study that aims to assess the effectiveness of dronabinol in improving pain and quality of life, as well as its impact on inflammation markers compared to a placebo. Participants will be monitored for safety and tolerability throughout the study duration.

Why it matters

Who can join: the full rules

* 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

Where it's running

• Mount Sinai Hospital
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Susanna Curtis — Mount Sinai Hospital
• Study coordinator: Susanna Curtis, MD, PhD
• Email: susanna.curtis@mssm.edu
• Phone: 2036718154

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Virtual reality options to help with VOC pain in adults with SCD

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.