Recruiting
Phase 2
Cannabinoids for the Reduction of Inflammation and Sickle Cell Related Pain
About this 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).
- Condition
- Sickle Cell Disease
- Tested
- Dronabinol, Placebo
- Sponsor
- Icahn School of Medicine at Mount Sinai
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 17
- Minimum age: 18 years
- Study condition: Sickle Cell Disease
- 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
1 site, 1 recruiting
Mount Sinai Hospital
New York, New York, United States
Contact
-
Susanna Curtis, MD, PhD
2036718154 susanna.curtis@mssm.edu
Potential match only. Final eligibility is determined by the study team.