Using cannabinoids to reduce inflammation and pain in sickle cell disease
Dronabinol for the Reduction of Chronic Pain and Inflammation in People With Sickle Cell Disease
This study is testing if a cannabinoid called dronabinol can help adults with sickle cell disease feel less pain and improve their quality of life.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Drugs / interventions | crizanlizumab |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05519111 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with a clinical diagnosis of sickle cell disease and chronic pain.
Not a fit: Patients with a history of psychotic episodes or those who are currently pregnant or nursing may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate pain and improve the quality of life for patients with sickle cell disease.
How similar studies have performed: Other studies have explored cannabinoid treatments for pain management, showing promising results, but this specific approach is still being evaluated.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.