Cannabinoids for the Reduction of Inflammation and Sickle Cell Related Pain
NCT ID: NCT05519111
Last Updated: 2025-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2025-04-03
2027-05-01
Brief Summary
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Detailed Description
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Primary Objective: To determine whether dronabinol will improve pain and QOL in adults with SCD and chronic pain.
Secondary Objectives: To assess dronabinol's effect on markers of inflammation in patients with SCD compared to placebo.
To determine the safety and tolerability of dronabinol use in adults with SCD compared to placebo.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Dronabinol
BID for 8 weeks. Dosage will be individualized per patient. In days 1-4 of the study each patient will be titrated from 5mg bid to a minimum dose of 2.5 mg bid to a maximum dose of 10 mg bid depending on patient preference.
Dronabinol
Dronabinol, an FDA approval oral agent containing synthetic tetrahydrocannabinol (THC)
Placebo
A placebo comparator
Placebo
placebo equivalent
Interventions
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Dronabinol
Dronabinol, an FDA approval oral agent containing synthetic tetrahydrocannabinol (THC)
Placebo
placebo equivalent
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Icahn School of Medicine at Mount Sinai
OTHER
Responsible Party
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Susanna Curtis
Assistant Professor
Principal Investigators
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Susanna Curtis
Role: PRINCIPAL_INVESTIGATOR
MOUNT SINAI HOSPITAL
Locations
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Mount Sinai Hospital
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GCO 22-1141
Identifier Type: -
Identifier Source: org_study_id
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