Cannabinoids for the Reduction of Inflammation and Sickle Cell Related Pain

ID#: NCT05519111

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 2

Recruitment Status: Recruiting

Start Date: October 01, 2022

End Date: September 01, 2025

Contact Information:
Susanna Curtis, MD, PhD
2036718154
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).
Eligibility:

- 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
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