Sickle Cell DiseasePhase 2CRISPNCT05519111
Cannabinoids for the Reduction of Inflammation and Sickle Cell Related Pain
A Phase 2 study testing Dronabinol in people with Sickle Cell Disease, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Dronabinol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2025to 1 May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mount Sinai Hospital
New York, New York, 10029
Susanna Curtis, MD, PhD, susanna.curtis@mssm.edu
Susanna Curtis
About this study
Official title: Dronabinol for the Reduction of Chronic Pain and Inflammation in People With Sickle Cell Disease
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).
Read the 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.
- Conditions
- Sickle Cell Disease
- Being tested
- Dronabinol, Placebo
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DronabinolDrug
Also called Marinol
Dronabinol, an FDA approval oral agent containing synthetic tetrahydrocannabinol (THC)
PlaceboDrug
placebo equivalent
| Study group | Role | What they receive |
|---|---|---|
| Dronabinol | Experimental | 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. Receives: Drug: Dronabinol |
| Placebo | Placebo comparator | A placebo comparator Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: end of study at 8 weeks
Secondary outcomes (19)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: end of study at 8 weeks
tryptase
marker of Inflammation. tryptase is an enzyme found in mast cells
Measured: 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.
Measured: end of study at 8 weeks
Vascular cell adhesion protein 1 (VCAM-1)
marker of Inflammation. plasma levels of oxidative stress and adhesion molecules
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: end of study at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start3 Apr 2025
- Primary completion1 Apr 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized 1:1 to dronabinol or placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Susanna Curtis, Icahn School of Medicine at Mount Sinai
- Investigators
- Susanna Curtis, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05519111
- Sponsor's protocol ID
- GCO 22-1141
- Other IDs
- K23HL151884
- Acronym
- CRISP
- Status last verified
- Sep 2025
- First submitted
- 25 Aug 2022
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dronabinol for the Reduction of Chronic Pain and Inflammation in People With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT05519111
- Acronym / sponsor ID
- CRISP / GCO 22-1141
- Conditions
- Sickle Cell Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 29 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized 1:1 to dronabinol or placebo.
| Arm | Type | Receives |
|---|---|---|
| Dronabinol | Experimental | Drug: DronabinolBID 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. |
| Placebo | Placebo comparator | Drug: PlaceboA placebo comparator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DronabinolAlso: MarinolDronabinol, an FDA approval oral agent containing synthetic tetrahydrocannabinol (THC) | Drug | Dronabinol |
| Placeboplacebo equivalent | Drug | Placebo |
Primary outcome
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.
19 secondary outcomes
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
tumor necrosis factor alpha (TNFα).
Time frame: end of study at 8 weeks
PROMIS domains
Time frame: end of study at 8 weeks
Columbia suicide severity rating scale
Time frame: end of study at 8 weeks
Prodromal questionnaire brief version (PQ-B)
Time frame: end of study at 8 weeks
PROMIS domain for neuropathic pain quality
Time frame: end of study at 8 weeks
PROMIS domain for nociceptive pain quality
Time frame: end of study at 8 weeks
The Leeds assessment of neuropathic symptoms and signs (LANSS) Pain Scale
Time frame: end of study at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Susanna Curtis principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dronabinol in people with Sickle Cell Disease, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susanna Curtis, MD, PhD (2036718154, susanna.curtis@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Reported Measurement Outcome Information System (PROMIS) pain impact score (time frame: end of study at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.