Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2025-12-26 @ 5:18 PM
Study NCT ID:
NCT05269706
Status:
COMPLETED
Last Update Posted:
2025-02-14
First Post:
2022-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigation of the Pharmacokinetic Profile of CBD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, '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'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Study will be conducted using a cross-over design, separated by a 1-week washout period.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2023-02-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-12', 'studyFirstSubmitDate': '2022-02-16', 'studyFirstSubmitQcDate': '2022-02-25', 'lastUpdatePostDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systematic Assessment for Treatment Emergent Events (SAFTEE)', 'timeFrame': 'up to 24 hours post-treatment', 'description': 'Systematic Assessment for Treatment Emergent Events (SAFTEE) to measure safety and adverse events.'}, {'measure': 'Peak Plasma Concentration (Cmax)', 'timeFrame': 'up to 24 hours post-treatment', 'description': 'Peak plasma concentration of CBD and its metabolites'}, {'measure': 'Area under the plasma concentration curve (AUC)', 'timeFrame': 'up to 24 hours post-treatment', 'description': 'Area under the plasma concentration versus time curve'}], 'secondaryOutcomes': [{'measure': 'Peak urine concentration of CBD (Umax)', 'timeFrame': 'up to 24 hours post-treatment', 'description': 'Peak urinary excretion of CBD and its metabolites'}, {'measure': 'Area under the urine concentration curve (AUC)', 'timeFrame': 'up to 24 hours post-treatment', 'description': 'Area under the urine concentration versus time curve'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Methadone', 'Buprenorphine', 'Opioid Use Disorder'], 'conditions': ['Opioid Use Disorder']}, 'descriptionModule': {'briefSummary': 'The goal of the current study is to evaluate the bioavailability of CBD in normal healthy Individuals. This is an open cross-overdesign study in healthy individuals to assess the safety and pharmacokinetic (PK) effects of cannabidiol.', 'detailedDescription': 'The goal of this study is to determine the pharmacokinetics and pharmacodynamic profile of CBD in normal healthy individuals under standard and high fat fed conditions.\n\nCBD has recently gained significant attention as a potential treatment for various disorders. One aspect for consideration in the development of CBD medication in capsule form is the poor bioavailability of cannabinoids such as CBD to obtain clinically effective doses since only \\~4-6% of CBD is absorbed orally. This study will investigate the potential of CBD in a formulation in a capsule to enhance bioavailability, reduce the incidence of gastrointestinal side effects, reduce first pass metabolism and enhance onset time. This PK study will be conducted with standard meal and high fat conditions in normal healthy volunteers in a cross-over design, separated by a washout period of 1 week. Healthy volunteers are defined as having no significant health-related issues (i.e., the absence of significant medical, psychosocial, or emotional conditions) that are verified by clinical and psychiatric assessments.\n\nThe study will first evaluate in healthy volunteers the PK, tolerability and safety profiles of a new CBD formulation designed to improve bioavailability.\n\nTest conditions and order:\n\n1. 200 mg CBD (standard meal)\n2. 400 mg CBD (standard meal)\n3. 400 mg Epidiolex (standard meal)\n4. 400 mg CBD (high fat meal)\n\nBlood samples will be taken at -60,15, 30, 45 and 60 min and1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours associated with administration of the CBD capsules.\n\nMonitoring period for PK: 24 hours (plasma and urine PK). Participation in 4 test conditions for a duration of approximately 4 weeks and a 1-week follow-up assessment.\n\nTotal length of in-house stay is 12 hours, with participants returning the following day for 24-hour time point procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to understand and give informed consent;\n* Individuals between 18 and 65 years old; Sex is used a biological factor (50% of individuals recruited will be females, allowing sex comparisons).\n* English speakers.\n* Being healthy as determined by study physician according to screening medical and psychiatric history, physical examination, vitals, ECG and safety laboratory values. Only healthy volunteers with normal hepatic laboratory values will be enrolled.\n* Healthy volunteers who are medication- and drug-free, including free from nicotine and any prescribed medications.\n\nExclusion Criteria:\n\n* Having present or past medical conditions, including a DSM-5 Axis I psychiatric disorder, history of cardiac disease, arrhythmias, neurological disease of central origin, head trauma, and seizures\n* Using any psychoactive drug (other than nicotine) in at least the past 7 days (determined by lack of acute-opioid or other drugs related withdrawal symptoms and the negative result of a urine drug screen including an opioid drug metabolite test, and alcohol breathalyzer to detect alcohol intoxication);\n* Positive urine drug screen (cocaine, opiates, benzodiazepines, barbiturates, amphetamines, morphine, methadone, methamphetamines, oxycodone, phencyclidine, tricyclic antidepressant, tetrahydrocannabinol, buprenorphine, methylenedioxymethamphetamine, propoxyphene);\n* Having a history of hypersensitivity to cannabinoids or any of the ingredients in the product (gelatin and/or sesame oil);\n* Being pregnant or breastfeeding;\n* Not using an appropriate method of contraception such as hormonal contraception (oral hormonal contraceptives, Depo-Provera, Nuva-Ring), intrauterine device (IUD), sterilization, or double barrier method (combination of any two barrier methods used simultaneously, i.e. condom, spermicide, diaphragm);\n* Participating in another pharmacotherapeutic trial in the past 3 months;\n* History of impaired renal function or elevated liver enzymes at prescreening. The exclusionary lab values are: 3x nl AST/ALT, 1.5x bilirubin or 50%reduction in eGFR.\n* Participants who have used any medication, dietary supplements (and/or grape fruit juice), or combination of medications and supplements known to alter the metabolism of, or interact with CBD (bupropion, rifampin, barbiturates, phenothiazines, cimetidine, etc.) 14 days prior to and during the duration of the study.'}, 'identificationModule': {'nctId': 'NCT05269706', 'briefTitle': 'Investigation of the Pharmacokinetic Profile of CBD', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'Cannabidiol in the Treatment of Opioid Use Disorder', 'orgStudyIdInfo': {'id': 'STUDY-19-00681'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Standard Meal', 'description': 'Participants taking a standard meal.', 'interventionNames': ['Drug: Cannabidiol 200mg', 'Drug: Epidiolex', 'Drug: Cannabidiol 400mg', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'High Fat Meal', 'description': 'Participants taking a high fat meal.', 'interventionNames': ['Drug: Cannabidiol 200mg', 'Drug: Epidiolex', 'Drug: Cannabidiol 400mg', 'Drug: Placebo']}], 'interventions': [{'name': 'Cannabidiol 200mg', 'type': 'DRUG', 'otherNames': ['BSPG CBD'], 'description': 'Cannabidiol 200mg (twice daily)', 'armGroupLabels': ['High Fat Meal', 'Standard Meal']}, {'name': 'Epidiolex', 'type': 'DRUG', 'description': 'Epidiolex 400mg (twice daily)', 'armGroupLabels': ['High Fat Meal', 'Standard Meal']}, {'name': 'Cannabidiol 400mg', 'type': 'DRUG', 'otherNames': ['BSPG CBD'], 'description': 'Cannabidiol 400mg (twice daily)', 'armGroupLabels': ['High Fat Meal', 'Standard Meal']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching Placebo (Twice Daily)', 'armGroupLabels': ['High Fat Meal', 'Standard Meal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Yasmin Hurd, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yasmin Hurd', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yasmin Hurd', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}