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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
60
Dronabinol, an FDA approval oral agent containing synthetic tetrahydrocannabinol (THC)
placebo equivalent
Mount Sinai Hospital
New York, New York, United States
RECRUITINGPatient Reported Measurement Outcome Information System (PROMIS) pain impact score
Change in Patient Reported Measurement Outcome Information System (PROMIS) pain impact score. Total scale from 20-80, median of 50 and SD of 10. Higher score represent poorer health outcomes.
Time frame: end of study at 8 weeks
Adult Sickle Cell Quality of Life Information System (ASCQ-Me) Pain impact
Total scale from 20 to 80, median of 50 and SD of 10. Higher scores represent better health outcomes.
Time frame: end of study at 8 weeks
Quality of Life Outcomes
ASCQ-Me survey domains for emotional impact, social impact, stiffness, and sleep. Each domain scale from 20 to 80, median of 50 and SD of 10. Higher scores represent better health outcomes. Total scale from 20 to 80, median of 50 and SD of 10. Higher scores represent better health outcomes.
Time frame: end of study at 8 weeks
WBC with differential
a marker of Inflammation. The blood differential test measures the percentage of each type of white blood cell (WBC) in the blood. It also reveals if there are any abnormal or immature cells.
Time frame: end of study at 8 weeks
C-reactive protein (CRP)
marker of Inflammation. C-reactive protein (CRP) is produced by the liver. The level of CRP rises when there is inflammation throughout the body. It is one of a group of proteins, called acute phase reactants, that go up in response to inflammation. The levels of acute phase reactants increase in response to certain inflammatory proteins called cytokines. These proteins are produced by white blood cells during inflammation.
Time frame: end of study at 8 weeks
tryptase
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marker of Inflammation. tryptase is an enzyme found in mast cells
Time frame: end of study at 8 weeks
substance P
marker of Inflammation. Substance P ("P" standing for "Preparation" or "Powder") is a neuropeptide - but only nominally so, as it is ubiquitous. Its receptor - the neurokinin type 1 - is distributed over cytoplasmic membranes of many cell types (neurons, glia, endothelia of capillaries and lymphatics, fibroblasts, stem cells, white blood cells) in many tissues and organs. SP amplifies or excites most cellular processes.
Time frame: end of study at 8 weeks
Vascular cell adhesion protein 1 (VCAM-1)
marker of Inflammation. plasma levels of oxidative stress and adhesion molecules
Time frame: end of study at 8 weeks
cytokine IL1a
marker of Inflammation. Interleukin 1 alpha (IL-1α) also known as hematopoietin 1 is a cytokine of the interleukin 1 family that in humans is encoded by the IL1A gene.
Time frame: end of study at 8 weeks
cytokine IL1b
marker of Inflammation. Interleukin 1 beta (IL-1β) also known as leukocytic pyrogen, leukocytic endogenous mediator, mononuclear cell factor, lymphocyte activating factor and other names, is a cytokine protein that in humans is encoded by the IL1B gene.
Time frame: end of study at 8 weeks
cytokine IL6
marker of Inflammation. Interleukin-6 (IL-6) is a pleiotropic cytokine with central roles in immune regulation, inflammation, hematopoiesis, and oncogenesis.
Time frame: end of study at 8 weeks
cytokine IL4
marker of Inflammation. The interleukin 4 (IL4, IL-4) is a cytokine that induces differentiation of naive helper T cells (Th0 cells) to Th2 cells.
Time frame: end of study at 8 weeks
cytokine IL10
marker of Inflammation. Interleukin 10 (IL-10), also known as human cytokine synthesis inhibitory factor (CSIF), is an anti-inflammatory cytokine.
Time frame: end of study at 8 weeks
tumor necrosis factor alpha (TNFα).
marker of Inflammation. Tumor necrosis factor (TNF), a 17 kDa protein consisting of 157 amino acids, is a homotrimer in solution that is mainly produced by activated macrophages, T lymphocytes, and natural killer (NK) cells.
Time frame: end of study at 8 weeks
PROMIS domains
PROMIS domains for anxiety, appetite, nausea, and cognitive function, opioid use in oral morphine equivalents (OME), episodes of emergency room, hospital, or psychiatric facility utilization. Each domain scale from 20 to 80, median of 50 and SD of 10. Higher scores represent better health outcomes. Total scale from 20 to 80, median of 50 and SD of 10. Higher scores represent better health outcomes.
Time frame: end of study at 8 weeks
Columbia suicide severity rating scale
Columbia suicide severity rating scale. Full range from 0 to 9. Higher score represents higher intensity suicidal ideation.
Time frame: end of study at 8 weeks
Prodromal questionnaire brief version (PQ-B)
Prodromal questionnaire brief version: 21-item self-report instrument. Full scale range from 0 to 21, higher score represents poorer health outcomes
Time frame: end of study at 8 weeks
PROMIS domain for neuropathic pain quality
Total scale from 20-80, median of 50 and SD of 10. Higher scores represent worse outcomes.
Time frame: end of study at 8 weeks
PROMIS domain for nociceptive pain quality
Total scale from 20-80, median of 50 and SD of 10. Higher scores represent worse outcomes.
Time frame: end of study at 8 weeks
The Leeds assessment of neuropathic symptoms and signs (LANSS) Pain Scale
The Leeds assessment of neuropathic symptoms and signs (LANSS) Pain Scale comprises of a 7-item pain scale, including the sensory descriptors and items for sensory examination. Out of the seven items in the Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale (LANSS), five are symptom related and two are examination items. Full scale from scores between 0 and 24, higher score represents poorer health outcomes.
Time frame: end of study at 8 weeks