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).
Susanna Curtis, MD, PhD | |
2036718154 | |
[email protected] |
> 18 Years
Phase 2
Interventional
All
Drug
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