Cannabinoids for the Reduction of Inflammation and Sickle Cell Related Pain
RecruitingPhase 2NCT05519111
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- Official title
- Dronabinol for the Reduction of Chronic Pain and Inflammation in People With Sickle Cell Disease
- Conditions
- Interventions
- Drug: Dronabinol
- Drug: Placebo
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Start date
- 2025-04-03
- Primary completion
- 2027-04-01
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
* 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05519111