Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2026-01-01 @ 6:35 PM
Study NCT ID:
NCT06930703
Status:
RECRUITING
Last Update Posted:
2025-06-25
First Post:
2025-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cannabidiol in Sickle Cell Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002185', 'term': 'Cannabidiol'}], 'ancestors': [{'id': 'D002186', 'term': 'Cannabinoids'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-24', 'studyFirstSubmitDate': '2025-04-09', 'studyFirstSubmitQcDate': '2025-04-09', 'lastUpdatePostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tumor Necrosis Factor-alpha level', 'timeFrame': 'at 4 weeks', 'description': 'Plasma levels of tumor necrosis factor-alpha, a marker of inflammation in sickle cell disease will be collected.'}], 'secondaryOutcomes': [{'measure': 'Levels of Markers of Inflammation', 'timeFrame': 'at 4 weeks', 'description': 'Levels of inflammatory markers (IL1a, IL1b, IL6, IL4 and IL10) will be collected.'}, {'measure': 'White Blood Cell with differential', 'timeFrame': 'at 4 weeks', 'description': '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.'}, {'measure': 'C-reactive protein level', 'timeFrame': 'at 4 weeks', 'description': '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.'}, {'measure': 'Tryptase levels', 'timeFrame': 'at 4 weeks', 'description': '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.'}, {'measure': 'Substance P levels', 'timeFrame': 'at 4 weeks', 'description': '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.'}, {'measure': 'Cytokines levels', 'timeFrame': 'at 4 weeks', 'description': "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."}, {'measure': 'Adult Sickle Cell Quality of Life Measurement System', 'timeFrame': 'at 4 weeks', 'description': '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.'}, {'measure': 'Patient Reported Outcome Information System (PROMIS) to measure Pain', 'timeFrame': 'at 4 weeks', 'description': '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)'}, {'measure': 'Leeds Assessment of Neuropathic Symptoms and Signs pain scale (S-LANSS)', 'timeFrame': '4 weeks', 'description': 'Leeds assessment of neuropathic signs and symptoms\n\nThe 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.'}, {'measure': 'Patient Reported Outcomes Measurement Information System (PROMIS)', 'timeFrame': 'at 4 weeks', 'description': '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.'}, {'measure': 'Oral Morphine Equivalents (OME)', 'timeFrame': 'at 4 weeks', 'description': 'Oral Morphine Equivalents (OME)'}, {'measure': 'Number of Emergency Room Visits', 'timeFrame': 'at 4 weeks', 'description': 'Number of emergency room visits'}, {'measure': 'Number of Hospital Admissions', 'timeFrame': 'at 4 weeks', 'description': 'Number of hospital admissions'}, {'measure': 'Number of Psychiatric Facility Utilizations', 'timeFrame': 'at 4 weeks', 'description': 'Number of psychiatric facility utilization'}, {'measure': 'Columbia-Suicide Severity Rating Scale - Severity and Intensity Subscale (C-SSRS SI)', 'timeFrame': 'at 4 weeks', 'description': '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.'}, {'measure': 'Prodromal Questionnaire - Brief Version (PQ-B)', 'timeFrame': 'at 4 weeks', 'description': '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'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic pain', 'epidiolex', 'cannabidiol'], 'conditions': ['Sickle Cell Disease']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years\n* Clinical diagnosis of SCD (HbSS, HbSC, HbSβ+; Thal, HbSβ0Thal, HbS variants)\n* Baseline score of 60 or lower on the ASCQ-Me 7-day pain interference domain\n* If on a SCD modifying therapy (hydroxyurea, regular blood transfusions, L-glutamine, voxelotor, crizanlizumab), on stable dose for at least 3 months\n* If using opioids for pain at home, on stable dose for at least 3 months\n* One urine toxicology negative for cannabinoids within 30 days of randomization\n* Willing to abstain from cannabis, medical and illicit, during study weeks 1 through 4 • Not pregnant or nursing\n* 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.\n* Able to consent for research\n\nExclusion Criteria:\n\n* No known intolerance to cannabinoids\n* No history of psychotic episode, psychosis, or active suicidality\n* No contraindication to epidiolex with attention to potential side effects, concurrent medications/substances, and concurrent medical problems, as evaluated by a physician\n* Not a daily cannabis user\n* No diagnosis of active substance use disorder\n* No ALT\\>3 times the upper limit of normal'}, 'identificationModule': {'nctId': 'NCT06930703', 'acronym': 'SPICE', 'briefTitle': 'Cannabidiol in Sickle Cell Disease', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'Treatment of Sickle Cell Pain and Inflammation With Cannabidiol (SPICe)', 'orgStudyIdInfo': {'id': 'STUDY-24-00903'}, 'secondaryIdInfos': [{'id': 'IN123001222', 'type': 'OTHER_GRANT', 'domain': 'American Society of Hematology'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Twice daily matching placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cannabidiol 200 mg', 'description': 'Twice daily 200 mg cannabidiol', 'interventionNames': ['Drug: Cannabidiol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cannabidiol 400 mg', 'description': 'Twice daily 400 mg cannabidiol', 'interventionNames': ['Drug: Cannabidiol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cannabidiol 600 mg', 'description': 'Twice daily 600 mg cannabidiol', 'interventionNames': ['Drug: Cannabidiol']}], 'interventions': [{'name': 'Cannabidiol', 'type': 'DRUG', 'otherNames': ['Epidiolex'], 'description': 'Cannabidiol (CBD) twice daily taken orally for 4-weeks', 'armGroupLabels': ['Cannabidiol 200 mg', 'Cannabidiol 400 mg', 'Cannabidiol 600 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo equivalent twice daily taken orally for 4-weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'Manhattan', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Susanna Curtis, MD, PhD', 'role': 'CONTACT', 'email': 'susanna.curtis@mssm.edu'}, {'name': 'Susanna Curtis', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.78343, 'lon': -73.96625}}], 'centralContacts': [{'name': 'Susanna Curtis', 'role': 'CONTACT', 'email': 'susanna.curtis@mssm.edu', 'phone': '212-241-3650'}], 'overallOfficials': [{'name': 'Susanna Curtis', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Specify Other Time FrameOn request.', 'ipdSharing': 'YES', 'description': 'All of the individual participant data collected during the trial, after deidentification.', 'accessCriteria': 'Researchers who provide a methodologically sound proposal. Any purpose. Proposals should be directed to Susanna.curtis@mssm.edu. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Link TBD).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Susanna Curtis', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}