Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-02-20 @ 8:32 PM
Study NCT ID:
NCT05630235
Status:
RECRUITING
Last Update Posted:
2025-06-17
First Post:
2022-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of CBD/CBD-A Oral Extract on Resting-state EEG and Neuropathic Pain Symptoms After SCI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D009437', 'term': 'Neuralgia'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-16', 'studyFirstSubmitDate': '2022-11-18', 'studyFirstSubmitQcDate': '2022-11-18', 'lastUpdatePostDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in neuropathic pain intensity or unpleasantness.', 'timeFrame': 'Baseline, approximately 3 hours post intervention, and approximately 6 hours post intervention', 'description': 'Assess changes in pain intensity and unpleasantness of the worst neuropathic pain using a numerical rating scale from 0-10 (0 no pain and 10 worst imaginable/unpleasant pain).'}, {'measure': 'Change in brain electrocortical activity at rest.', 'timeFrame': 'Baseline and 3 hours post intervention', 'description': 'Assess brain electrocortical activity at rest using a 64-channel Biosemi EEG system and conducting EEG power spectrum analysis'}], 'secondaryOutcomes': [{'measure': 'Change in neuropathic pain symptoms severity using the NPSI.', 'timeFrame': 'Baseline, approximately 3 hours post intervention, and approximately 6 hours post intervention', 'description': 'The Neuropathic Pain Symptom Inventory (NPSI) will assess the presence and severity of common neuropathic pain symptoms. Range 0-100 with higher scores representing greater neuropathic pain symptoms.'}, {'measure': 'Change in sensory function using QST.', 'timeFrame': 'Baseline and 3 hours post intervention', 'description': 'Sensory function will be assessed using quantitative sensory testing (QST) using an FDA-approved Thermal Sensory Analyzer.'}, {'measure': 'Change in state anxiety using the STAI.', 'timeFrame': 'Baseline, approximately 3 hours post intervention, and approximately 6 hours post intervention', 'description': 'Using the State-trait Anxiety Inventory (STAI), we will evaluate changes in momentary anxiety with scores ranging from 5-20. Higher values equate to greater anxiety symptoms.'}, {'measure': 'Subjective Drug Effects', 'timeFrame': 'Baseline, approximately 3 hours post intervention, and approximately 6 hours post intervention', 'description': 'Drug Effects Questionnaire (DEQ): The DEQ is a brief five item instrument used to assess subjective drug effects. The five items are presented on a 100 mm visual analogue scale ranging from not at all to extremely. The participants are instructed to draw a vertical line at any place between the two responses'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['SCI - Spinal Cord Injury', 'Neuropathic Pain']}, 'descriptionModule': {'briefSummary': 'The main purposes of this study are to (1) measure the effect of CBD/CBD-A on pain symptoms, pain intensity, pain unpleasantness, and skin sensitivity to hot and cold temperatures; and (2) measure the effect of CBD on brain electrical activity with electroencephalography (EEG).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Men or Women;\n2. 18-64 years of age with an incomplete or complete acquired traumatic SCI;\n3. Must have experienced neuropathic pain for a minimum of three months before entering the study (neuropathic pain will be assessed using the International SCI Pain Classification);\n4. The pain intensity must be in the moderate to severe category, which will be defined as a score of at least four on an NRS (range of 0 to 10).\n5. Must have previous experience with consuming cannabis and or cannabinoids.\n\nExclusion Criteria:\n\n1. Current drug (DAST-10: \\>6) or alcohol abuse (AUDIT: \\>10);\n2. Current use of cannabis plant or cannabis products (CBD or CBD+THC) or any other drugs of abuse (unless prescribed) including alcohol;\n3. Presence of significant medical illness (e.g., diabetes, obesity, cardiovascular disease, hypertension, hepatitis) or other significant neurological trauma;\n4. History of or current severe psychopathology (e.g., major depressive disorder, bipolar disorder, schizophrenia, post-traumatic stress disorder) judged by the investigator to put the subject at greater risk of experiencing an adverse event;\n5. Adults who are unable to consent, women who are pregnant, breastfeeding, or not practicing an effective form of birth control (condoms, diaphragm, birth control pill, IUD), and prisoners;\n6. Current pregnancy. Pregnancy will be evaluated using a pregnancy test during the first study visit. Female subjects of childbearing potential will be required to use two forms of effective birth control for the 3 months prior to participating in the study and continuing for 1 month after completion of the study;\n7. Have a history of renal or hepatic disease: or\n8. Have elevated serum creatinine above the laboratory upper limit of normal (ULN): or\n9. Have elevated serum transaminases (ALT or AST) above the ULN: or\n10. Have elevated total bilirubin above the ULN; or\n11. Take valproate, due increased risk of liver enzyme elevation; or\n12. Currently using strong CYP2C19 and CYP3A4 inducers; or\n13. Have suicidal ideation (subjects should be screened for suicidal ideation); or\n14. Cannot abstain from the use of alcohol during the study period, due to increased risk of sedation; or\n15. Have a known or suspected hypersensitivity to cannabidiol or tetrahydrocannabinol.\n16. Have a known or suspected hypersensitivity to sesame seed oil, lecithin, or bovine gelatin.'}, 'identificationModule': {'nctId': 'NCT05630235', 'briefTitle': 'Effects of CBD/CBD-A Oral Extract on Resting-state EEG and Neuropathic Pain Symptoms After SCI', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Effects of a Hemp-derived Cannabidiol and Cannabidiolic-acid Oral Extract on Resting-state Electroencephalography and Neuropathic Pain Symptoms in People With Spinal Cord Injury', 'orgStudyIdInfo': {'id': '20220782'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CBD/CBD-A followed by placebo group', 'description': 'Participants in this group will receive a one time dose of CBD/CBD-A on visit 2, followed by a placebo on visit 3 after a two-week period.', 'interventionNames': ['Drug: CBD/CBD-A', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo followed by CBD/CBD-A group', 'description': 'Participants in this group will receive a placebo on visit 2, followed by a one time of CBD/CBD-A on visit 3 after a two-week period.', 'interventionNames': ['Drug: CBD/CBD-A', 'Other: Placebo']}], 'interventions': [{'name': 'CBD/CBD-A', 'type': 'DRUG', 'description': 'Participants will be administered a one-time dose of 204.6 mg of CBD/CBD-A orally.', 'armGroupLabels': ['CBD/CBD-A followed by placebo group', 'Placebo followed by CBD/CBD-A group']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'The placebo equivalent of the CBD/CBD-A dose administered orally.', 'armGroupLabels': ['CBD/CBD-A followed by placebo group', 'Placebo followed by CBD/CBD-A group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Eva Widerstrom-Noga, PhD, DDS', 'role': 'CONTACT', 'email': 'ewiderstrom-noga@med.miami.edu', 'phone': '305-243-7125'}, {'name': 'Eva Widerstrom-Noga, PhD, DDS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lynn Rehabilitation Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'centralContacts': [{'name': 'Eva Widerstrom-Noga, PhD, DDS', 'role': 'CONTACT', 'email': 'ewiderstrom-noga@med.miami.edu', 'phone': '+1 (305) 2437125'}], 'overallOfficials': [{'name': 'Eva Widerstrom-Noga, PhD, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'Consortium for Medical Marijuana Clinical Outcomes Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Professor', 'investigatorFullName': 'Eva Widerstrom-Noga', 'investigatorAffiliation': 'University of Miami'}}}}