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Recruiting NCT05519111

Cannabinoids for the Reduction of Inflammation and Sickle Cell Related Pain

Phase II Interventional Sickle Cell Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dronabinol, Placebo.
Who it may be relevant to
Registry conditions: Sickle Cell Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Detailed description

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.

Interventions

  • Drug Dronabinol
    Dronabinol, an FDA approval oral agent containing synthetic tetrahydrocannabinol (THC)
  • Drug Placebo
    placebo equivalent

Primary outcome measures

  • Patient Reported Measurement Outcome Information System (PROMIS) pain impact score [Time frame: end of study at 8 weeks]
Secondary outcome measures (12)
  • Adult Sickle Cell Quality of Life Information System (ASCQ-Me) Pain impact [Time frame: end of study at 8 weeks]
  • Quality of Life Outcomes [Time frame: end of study at 8 weeks]
  • WBC with differential [Time frame: end of study at 8 weeks]
  • C-reactive protein (CRP) [Time frame: end of study at 8 weeks]
  • tryptase [Time frame: end of study at 8 weeks]
  • substance P [Time frame: end of study at 8 weeks]
  • Vascular cell adhesion protein 1 (VCAM-1) [Time frame: end of study at 8 weeks]
  • cytokine IL1a [Time frame: end of study at 8 weeks]
  • cytokine IL1b [Time frame: end of study at 8 weeks]
  • cytokine IL6 [Time frame: end of study at 8 weeks]
  • cytokine IL4 [Time frame: end of study at 8 weeks]
  • cytokine IL10 [Time frame: end of study at 8 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Mount Sinai Hospital — New York

Identifiers

NCT: NCT05519111 · GCO 22-1141 · K23HL151884

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗