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NCT Number: NCT05519111

Cannabinoids for the Reduction of Inflammation and Sickle Cell Related Pain

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).

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Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mount Sinai Hospital

New York, 10029, United States

Location status: Recruiting

Location contact

Susanna Curtis

PRINCIPAL_INVESTIGATOR

Susanna Curtis, MD, PhD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Dronabinol

Drug

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

Other names: Marinol

Placebo

Drug

placebo equivalent

Primary outcomes

  1. Patient Reported Measurement Outcome Information System (PROMIS) pain impact score

    Time frame: 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 outcomes

  1. Adult Sickle Cell Quality of Life Information System (ASCQ-Me) Pain impact

    Time frame: 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.

  2. Quality of Life Outcomes

    Time frame: 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.

  3. WBC with differential

    Time frame: 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.

  4. C-reactive protein (CRP)

    Time frame: 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.

  5. tryptase

    Time frame: end of study at 8 weeks

    marker of Inflammation. tryptase is an enzyme found in mast cells

  6. substance P

    Time frame: 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.

  7. Vascular cell adhesion protein 1 (VCAM-1)

    Time frame: end of study at 8 weeks

    marker of Inflammation. plasma levels of oxidative stress and adhesion molecules

  8. cytokine IL1a

    Time frame: 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.

  9. cytokine IL1b

    Time frame: 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.

  10. cytokine IL6

    Time frame: 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.

  11. cytokine IL4

    Time frame: 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.

  12. cytokine IL10

    Time frame: 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.

  13. tumor necrosis factor alpha (TNFα).

    Time frame: 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.

  14. PROMIS domains

    Time frame: 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.

  15. Columbia suicide severity rating scale

    Time frame: end of study at 8 weeks

    Columbia suicide severity rating scale. Full range from 0 to 9. Higher score represents higher intensity suicidal ideation.

  16. Prodromal questionnaire brief version (PQ-B)

    Time frame: 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

  17. PROMIS domain for neuropathic pain quality

    Time frame: end of study at 8 weeks

    Total scale from 20-80, median of 50 and SD of 10. Higher scores represent worse outcomes.

  18. PROMIS domain for nociceptive pain quality

    Time frame: end of study at 8 weeks

    Total scale from 20-80, median of 50 and SD of 10. Higher scores represent worse outcomes.

  19. The Leeds assessment of neuropathic symptoms and signs (LANSS) Pain Scale

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Susanna Curtis, MD, PhD

CONTACT

[email protected]

2036718154

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Acronym: CRISP

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 29, 2022
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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