INTERVENTIONALRECRUITINGNCT05519111

Dronabinol for the Reduction of Chronic Pain and Inflammation in People With Sickle Cell Disease

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).

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2025-10-02

What this record can show

Protocol only - no registry results posted

This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.

Registry facts

Study at a glance

Phase: PHASE2
Enrollment: 60 (ESTIMATED)
Start date: 2025-04-03
Sponsor: Icahn School of Medicine at Mount Sinai
Design: RANDOMIZED · PARALLEL · SUPPORTIVE CARE
Locations: 1
Results record: Not present in registry snapshot

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). 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.

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Interventions

What was registered

DRUG

Dronabinol

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

Marinol

DRUG

Placebo

placebo equivalent

Eligibility

Population and criteria

Sex: ALL
Minimum age: 18 Years
Maximum age: Not reported
Healthy volunteers: Not accepted

Eligibility 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

primary outcomes