Cannabinoids for the Reduction of Inflammation and Sickle Cell Related Pain

Sickle Cell Disease Clinical Trial

— CRISP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05519111
• Other study ID #: GCO 22-1141
• Secondary ID: K23HL151884
• Status: Recruiting
• Phase: Phase 2
• Start date: October 1, 2022
• Est. completion date: October 30, 2025

Study information

• Verified date: June 2023
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Susanna Curtis, MD, PhD
• Phone: 2036718154
• Email: susanna.curtis[@]mssm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 30, 2025
• Est. primary completion date: October 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• Age >18 years
• Clinical diagnosis of SCD (HbSS, HbSC, HbSß+; Thal, HbSß0Thal, 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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Inflammation
• Sickle Cell Disease

Intervention

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

Locations

Country	Name	City	State
United States	Mount Sinai Hospital	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient 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.	end of study at 8 weeks
Secondary	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.	end of study at 8 weeks
Secondary	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.	end of study at 8 weeks
Secondary	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.	end of study at 8 weeks
Secondary	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.	end of study at 8 weeks
Secondary	tryptase	marker of Inflammation. tryptase is an enzyme found in mast cells	end of study at 8 weeks
Secondary	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.	end of study at 8 weeks
Secondary	Vascular cell adhesion protein 1 (VCAM-1)	marker of Inflammation. plasma levels of oxidative stress and adhesion molecules	end of study at 8 weeks
Secondary	cytokine IL1a	marker of Inflammation. Interleukin 1 alpha (IL-1a) also known as hematopoietin 1 is a cytokine of the interleukin 1 family that in humans is encoded by the IL1A gene.	end of study at 8 weeks
Secondary	cytokine IL1b	marker of Inflammation. Interleukin 1 beta (IL-1ß) 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.	end of study at 8 weeks
Secondary	cytokine IL6	marker of Inflammation. Interleukin-6 (IL-6) is a pleiotropic cytokine with central roles in immune regulation, inflammation, hematopoiesis, and oncogenesis.	end of study at 8 weeks
Secondary	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.	end of study at 8 weeks
Secondary	cytokine IL10	marker of Inflammation. Interleukin 10 (IL-10), also known as human cytokine synthesis inhibitory factor (CSIF), is an anti-inflammatory cytokine.	end of study at 8 weeks
Secondary	tumor necrosis factor alpha (TNFa).	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.	end of study at 8 weeks
Secondary	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.	end of study at 8 weeks
Secondary	Columbia suicide severity rating scale	Columbia suicide severity rating scale. Full range from 0 to 9. Higher score represents higher intensity suicidal ideation.	end of study at 8 weeks
Secondary	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	end of study at 8 weeks
Secondary	PROMIS domain for neuropathic pain quality	Total scale from 20-80, median of 50 and SD of 10. Higher scores represent worse outcomes.	end of study at 8 weeks
Secondary	PROMIS domain for nociceptive pain quality	Total scale from 20-80, median of 50 and SD of 10. Higher scores represent worse outcomes.	end of study at 8 weeks
Secondary	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.	end of study at 8 weeks