Sickle Cell DiseasePhase 1/2SPICENCT06930703
Cannabidiol in Sickle Cell Disease
A Phase 1/2 study testing Cannabidiol in people with Sickle Cell Disease, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Randomized, placebo-controlled, double masked, dose finding study of twice daily cannabidiol given at 3 dose levels, 200mg, 400mg, and 600mg, compared to placebo for 4 weeks. 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?
- Cannabidiol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2025to 1 Feb 2027
- Phase
- Phase 1/2
- 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
Who may be able to join
- 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
Show all 9Show fewer
- Willing to abstain from cannabis, medical and illicit, during study weeks 1 through 4 • 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
Who cannot join
- No known intolerance to cannabinoids
- No history of psychotic episode, psychosis, or active suicidality
- No contraindication to epidiolex with attention to potential side effects, concurrent medications/substances, and concurrent medical problems, as evaluated by a physician
- Not a daily cannabis user
- No diagnosis of active substance use disorder
- No ALT>3 times the upper limit of normal
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
Icahn School of Medicine at Mount Sinai
Manhattan, New York, 10029
Susanna Curtis, MD, PhD, susanna.curtis@mssm.edu
Susanna Curtis
About this study
Official title: Treatment of Sickle Cell Pain and Inflammation With Cannabidiol (SPICe)
Randomized, placebo-controlled, double masked, dose finding study of twice daily cannabidiol given at 3 dose levels, 200mg, 400mg, and 600mg, compared to placebo for 4 weeks.
Read the detailed description
The researchers will conduct a randomized, double blind, placebo-controlled, study of cannabidiol in an oral formulation. Participants will be enrolled when they are not in pain crisis and have demonstrated a urine toxicology test free from cannabinoids in the past 30 days. The sample size will be 52 participants, aged ≥18, with 1:1:1:1 allocation of placebo to 3 drug doses. This is a dose finding study with a primary outcome of reduction of inflammatory cytokine TNFα.
- Conditions
- Sickle Cell Disease
- Being tested
- Cannabidiol, Placebo
- Keywords
- chronic pain, epidiolex, cannabidiol
- Medical subject headings
- Anemia, Sickle Cell, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabidiolDrug
Also called Epidiolex
Cannabidiol (CBD) twice daily taken orally for 4-weeks
PlaceboDrug
Placebo equivalent twice daily taken orally for 4-weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Twice daily matching placebo Receives: Drug: Placebo |
| Cannabidiol 200 mg | Active comparator | Twice daily 200 mg cannabidiol Receives: Drug: Cannabidiol |
| Cannabidiol 400 mg | Active comparator | Twice daily 400 mg cannabidiol Receives: Drug: Cannabidiol |
| Cannabidiol 600 mg | Active comparator | Twice daily 600 mg cannabidiol Receives: Drug: Cannabidiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Necrosis Factor-alpha level
Plasma levels of tumor necrosis factor-alpha, a marker of inflammation in sickle cell disease will be collected.
Measured: at 4 weeks
Secondary outcomes (16)
Levels of Markers of Inflammation
Levels of inflammatory markers (IL1a, IL1b, IL6, IL4 and IL10) will be collected.
Measured: at 4 weeks
White Blood Cell with differential
The blood differential test measures the percentage of each type of white blood cell (WBC) that are in the blood. This test is done to diagnose an infection, anemia, or leukemia. It may also be used to monitor a condition or to see if treatment is working.
Measured: at 4 weeks
C-reactive protein level
C-reactive protein (CRP) is produced by the liver. The CRP test is a general test to check for inflammation in the body. It is not a specific test. This means it can reveal that inflammation is present somewhere in the body, but it cannot pinpoint the exact location or reason.
Measured: at 4 weeks
Tryptase levels
Tryptase is enzyme released by mast cells in the body during allergic reactions and other immune responses. Elevated levels in the blood can indicate severe allergic reactions (like anaphylaxis), mast cell disorders, or certain inflammatory conditions.
Measured: at 4 weeks
Substance P levels
Substance P is neuropeptide that functions as a neurotransmitter and acts as a key mediator of pain sensation and inflammation in the body. It plays a role in various physiological processes including stress responses, mood regulation, and neurogenic inflammation.
Measured: at 4 weeks
Cytokines levels
Cytokines is a protein measured in blood samples to assess the body's immune and inflammatory responses to treatment. Elevated or reduced levels can indicate how the immune system is reacting and may help determine treatment effectiveness or disease progression.
Measured: at 4 weeks
Adult Sickle Cell Quality of Life Measurement System
The ASCQ-Me pain scale ranges from 0-100, with a standardized sickle cell disease population mean of 50 (standard deviation=10), where lower scores signify worse disease impact.
Measured: at 4 weeks
Patient Reported Outcome Information System (PROMIS) to measure Pain
Patient Reported Outcome Information System (PROMIS) domains for pain impact, neuropathic pain, and nociceptive pain: A standardized patient-reported measure assessing different aspects of pain experience. The measure includes subscales for pain impact (0-40), neuropathic pain (0-30), and nociceptive pain (0-30), each evaluating distinct pain mechanisms and experiences. Total score ranges from 0-100, with higher scores indicating greater pain severity and impact on daily functioning. Results are reported as T-scores (population mean=50, standard deviation=10)
Measured: at 4 weeks
Leeds Assessment of Neuropathic Symptoms and Signs pain scale (S-LANSS)
Leeds assessment of neuropathic signs and symptoms
The S-LANSS is a self-reported version of the Leeds Assessment of Neuropathic Symptoms and Signs pain scale. It aims to differentiate neuropathic pain (pain from nerve damage) from somatic or nociceptive pain (pain from body damage). Scores range from 0-24, with higher scores indicating greater pain.
Measured: 4 weeks
Patient Reported Outcomes Measurement Information System (PROMIS)
The PROMIS (Patient-Reported Outcomes Measurement Information System) for domains: Anxiety, Appetite, Nausea, and Cognitive function. The PROMIS measure is a brief, computer-adapted measure of symptoms for the domains. Each is a normalized measure with a mean of 50 and standard deviation of 10. Higher scores represent increased symptoms.
Measured: at 4 weeks
Oral Morphine Equivalents (OME)
Oral Morphine Equivalents (OME)
Measured: at 4 weeks
Number of Emergency Room Visits
Number of emergency room visits
Measured: at 4 weeks
Number of Hospital Admissions
Number of hospital admissions
Measured: at 4 weeks
Number of Psychiatric Facility Utilizations
Number of psychiatric facility utilization
Measured: at 4 weeks
Columbia-Suicide Severity Rating Scale - Severity and Intensity Subscale (C-SSRS SI)
The C-SSRS rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The subscale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI ranges from 0 (no SI) to 5 (active SI with plan and intent). Higher score indicates more severity.
Measured: at 4 weeks
Prodromal Questionnaire - Brief Version (PQ-B)
The Prodromal Questionnaire Brief Version (PQ-B) is a patient questionnaire that assesses the existence of a prodromal state or fully developed psychosis. The PQ-B includes 21 items that refer to thoughts, feelings and experiences that describe various symptoms, including abnormal perception, unconventional thinking, paranoia and negative symptoms. For each item, the participant is asked to indicate whether they had experienced that phenomenon in the past month (yes/no). The total score is calculated by summing the number of "yes" responses across all items. Full range is 0-21, with higher scores indicating a greater likelihood of experiencing prodromal symptoms or fully developed psychosis
Measured: at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start3 Apr 2025
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 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 1/2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Twice daily cannabidiol given at 3 dose levels, 200mg, 400mg, and 600mg, for 4 weeks, with 1:1:1:1 allocation of placebo to 3 drug doses.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susanna Curtis, Icahn School of Medicine at Mount Sinai
- Investigators
- Susanna Curtis, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06930703
- Sponsor's protocol ID
- STUDY-24-00903
- Other IDs
- IN123001222
- Acronym
- SPICE
- Status last verified
- Apr 2025
- First submitted
- 9 Apr 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Sickle Cell Pain and Inflammation With Cannabidiol (SPICe)
- ClinicalTrials.gov ID
- NCT06930703
- Acronym / sponsor ID
- SPICE / STUDY-24-00903
- Conditions
- Sickle Cell Disease
- Keywords
- chronic pain, epidiolex, cannabidiol
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 16 Apr 2025 (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.
Randomized, placebo-controlled, double masked, dose finding study of twice daily cannabidiol given at 3 dose levels, 200mg, 400mg, and 600mg, compared to placebo for 4 weeks.
Detailed description
The researchers will conduct a randomized, double blind, placebo-controlled, study of cannabidiol in an oral formulation. Participants will be enrolled when they are not in pain crisis and have demonstrated a urine toxicology test free from cannabinoids in the past 30 days. The sample size will be 52 participants, aged ≥18, with 1:1:1:1 allocation of placebo to 3 drug doses. This is a dose finding study with a primary outcome of reduction of inflammatory cytokine TNFα.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Twice daily cannabidiol given at 3 dose levels, 200mg, 400mg, and 600mg, for 4 weeks, with 1:1:1:1 allocation of placebo to 3 drug doses.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboTwice daily matching placebo |
| Cannabidiol 200 mg | Active comparator | Drug: CannabidiolTwice daily 200 mg cannabidiol |
| Cannabidiol 400 mg | Active comparator | Drug: CannabidiolTwice daily 400 mg cannabidiol |
| Cannabidiol 600 mg | Active comparator | Drug: CannabidiolTwice daily 600 mg cannabidiol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- No known intolerance to cannabinoids
- No history of psychotic episode, psychosis, or active suicidality
- No contraindication to epidiolex with attention to potential side effects, concurrent medications/substances, and concurrent medical problems, as evaluated by a physician
- Not a daily cannabis user
- No diagnosis of active substance use disorder
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 |
|---|---|---|
| CannabidiolAlso: EpidiolexCannabidiol (CBD) twice daily taken orally for 4-weeks | Drug | Cannabidiol 200 mg, Cannabidiol 400 mg, Cannabidiol 600 mg |
| PlaceboPlacebo equivalent twice daily taken orally for 4-weeks | Drug | Placebo |
Primary outcome
Tumor Necrosis Factor-alpha level
Time frame: at 4 weeks
Plasma levels of tumor necrosis factor-alpha, a marker of inflammation in sickle cell disease will be collected.
16 secondary outcomes
Levels of Markers of Inflammation
Time frame: at 4 weeks
White Blood Cell with differential
Time frame: at 4 weeks
C-reactive protein level
Time frame: at 4 weeks
Tryptase levels
Time frame: at 4 weeks
Substance P levels
Time frame: at 4 weeks
Cytokines levels
Time frame: at 4 weeks
Adult Sickle Cell Quality of Life Measurement System
Time frame: at 4 weeks
Patient Reported Outcome Information System (PROMIS) to measure Pain
Time frame: at 4 weeks
Leeds Assessment of Neuropathic Symptoms and Signs pain scale (S-LANSS)
Time frame: 4 weeks
Patient Reported Outcomes Measurement Information System (PROMIS)
Time frame: at 4 weeks
Oral Morphine Equivalents (OME)
Time frame: at 4 weeks
Number of Emergency Room Visits
Time frame: at 4 weeks
Number of Hospital Admissions
Time frame: at 4 weeks
Number of Psychiatric Facility Utilizations
Time frame: at 4 weeks
Columbia-Suicide Severity Rating Scale - Severity and Intensity Subscale (C-SSRS SI)
Time frame: at 4 weeks
Prodromal Questionnaire - Brief Version (PQ-B)
Time frame: at 4 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 25 Jun 2025.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
Related trials for Sickle Cell Disease
Active, not recruitingObservational study
Investigating the Mechanistic Effects of Mitapivat in Subjects With Sickle Cell Disease
Sickle Cell Anemia, Sickle Cell Thalassemia
Active, not recruitingPhase 2
A Dose-Finding Study of Tebapivat to Assess Efficacy, and Safety in Participants With Sickle Cell Disease (SCD)
Sickle Cell Disease
Enrolling by invitationPhase 4
A Study to Provide Access to Mitapivat for Participants Who Previously Participated in an Agios-Sponsored Mitapivat Study
Pyruvate Kinase Deficiency, Anemia, Hemolytic
RecruitingPhase 3
A Study to Investigate the Effect of Mitapivat on Transfusion Burden in Subjects With Sickle Cell Disease (SCD)
Sickle Cell Disease
RecruitingObservational study
Hydroxyurea Optimisation in Sickle Cell Disease
Sickle Cell Disease
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
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cannabidiol 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?
The sponsor lists 9 inclusion and 6 exclusion criteria. 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 25 Jun 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 (212-241-3650, susanna.curtis@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor Necrosis Factor-alpha level (time frame: at 4 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 25 Jun 2025.