NCT05519111RecruitingPhase 2
Cannabinoids for the Reduction of Inflammation and Sickle Cell Related Pain
Dronabinol for the Reduction of Chronic Pain and Inflammation in People With Sickle Cell Disease
Source: ClinicalTrials.gov · Last updated 2 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 25 Aug 2022
- Start date
- 3 Apr 2025
- Primary completion date
- 1 Apr 2027
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Diseases
- Sickle cell disease
- NCT number
- NCT05519111
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 3 Apr 2025 to the primary completion date, 1 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mount Sinai Hospital Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.