Dronabinol for the Reduction of Chronic Pain and Inflammation in People With Sickle Cell Disease

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).

Study point of contact

Susanna Curtis, MD, PhD
2036718154
[email protected]

Locations

83 United States sites

Age

> 18 Years

Phase

Phase 2

Study type

Interventional

Gender

All

Interventions

Drug

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

Locations

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

MORE INFORMATION

View on ClinicalTrials.gov
Enroll Now
Last updated 2023-06-12