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RECRUITINGPhase 2INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

Who May Be Eligible (Plain English)

* 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
* 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

Treatments Being Tested

DRUG

Dronabinol

Dronabinol, an FDA approval oral agent containing synthetic tetrahydrocannabinol (THC)

DRUG

Placebo

placebo equivalent

Locations (1)

Mount Sinai Hospital
New York, New York, United States