Cannabinoids for the Reduction of Inflammation and Sickle Cell Related Pain

• Status: Not yet recruiting
• Trial end date: 2025-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Dronabinol

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