Cannabinoids for the Reduction of Inflammation and Sickle Cell Related Pain
- Registration Number
- NCT05519111
- Lead Sponsor
- Icahn School of Medicine at Mount Sinai
- Brief Summary
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo A placebo comparator Dronabinol 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.
- Primary Outcome Measures
Name Time Method Patient Reported Measurement Outcome Information System (PROMIS) pain impact score end of study at 8 weeks 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.
- Secondary Outcome Measures
Name Time Method tumor necrosis factor alpha (TNFα). end of study at 8 weeks 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.
The Leeds assessment of neuropathic symptoms and signs (LANSS) Pain Scale end of study at 8 weeks 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.Adult Sickle Cell Quality of Life Information System (ASCQ-Me) Pain impact end of study at 8 weeks Total scale from 20 to 80, median of 50 and SD of 10. Higher scores represent better health outcomes.
Quality of Life Outcomes end of study at 8 weeks 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.WBC with differential end of study at 8 weeks 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.
C-reactive protein (CRP) end of study at 8 weeks 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.
tryptase end of study at 8 weeks marker of Inflammation. tryptase is an enzyme found in mast cells
cytokine IL10 end of study at 8 weeks marker of Inflammation. Interleukin 10 (IL-10), also known as human cytokine synthesis inhibitory factor (CSIF), is an anti-inflammatory cytokine.
Vascular cell adhesion protein 1 (VCAM-1) end of study at 8 weeks marker of Inflammation. plasma levels of oxidative stress and adhesion molecules
cytokine IL1a end of study at 8 weeks 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.
substance P end of study at 8 weeks 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.
cytokine IL1b end of study at 8 weeks 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.
cytokine IL6 end of study at 8 weeks marker of Inflammation. Interleukin-6 (IL-6) is a pleiotropic cytokine with central roles in immune regulation, inflammation, hematopoiesis, and oncogenesis.
cytokine IL4 end of study at 8 weeks 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.
PROMIS domain for nociceptive pain quality end of study at 8 weeks Total scale from 20-80, median of 50 and SD of 10. Higher scores represent worse outcomes.
PROMIS domains end of study at 8 weeks 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.Columbia suicide severity rating scale end of study at 8 weeks Columbia suicide severity rating scale. Full range from 0 to 9. Higher score represents higher intensity suicidal ideation.
PROMIS domain for neuropathic pain quality end of study at 8 weeks Total scale from 20-80, median of 50 and SD of 10. Higher scores represent worse outcomes.
Prodromal questionnaire brief version (PQ-B) end of study at 8 weeks Prodromal questionnaire brief version: 21-item self-report instrument. Full scale range from 0 to 21, higher score represents poorer health outcomes
Trial Locations
- Locations (1)
Mount Sinai Hospital
🇺🇸New York, New York, United States