Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-26 @ 3:50 AM
Study NCT ID:
NCT05088018
Status:
COMPLETED
Last Update Posted:
2022-06-07
First Post:
2021-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Swallowable Cannabigerol Tablets for Sleep Quality In Veterans (Veterans Exploring Cannabigerol for Sleep)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C037036', 'term': 'cannabigerol'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-04', 'studyFirstSubmitDate': '2021-10-11', 'studyFirstSubmitQcDate': '2021-10-11', 'lastUpdatePostDateStruct': {'date': '2022-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Sleep Biometric Activity', 'timeFrame': '4 weeks', 'description': 'Change in sleep Duration and quality from baseline to 4 weeks post-treatment, captured using a Fitbit Physical Activity Tracking Device'}, {'measure': 'Activity Biometric Activity', 'timeFrame': '4 weeks', 'description': 'Change in activity Duration and quality from baseline to 4 weeks post-treatment, captured using a Fitbit Physical Activity Tracking Device'}, {'measure': 'Heart Rate Biometric Activity', 'timeFrame': '4 weeks', 'description': 'Change in resting heart rate from baseline to 4 weeks post-treatment, captured using a Fitbit Physical Activity Tracking Device'}, {'measure': 'Medical Outcomes Study (MOS) Sleep Problems Index II', 'timeFrame': '2 weeks', 'description': "Change in sleep quality from baseline scores as measured by the Medical Outcomes Study (MOS) Sleep Problems Index II after 2 weeks' treatment. Scores range from 0-100, with higher scores indicating a worse outcome."}], 'primaryOutcomes': [{'measure': 'Medical Outcomes Study (MOS) Sleep Problems Index II', 'timeFrame': '4 weeks', 'description': 'Change in sleep quality from baseline scores as measured by the Medical Outcomes Study (MOS) Sleep Problems Index II after 4 weeks. Scores range from 0-100, with higher scores indicating a worse outcome.'}], 'secondaryOutcomes': [{'measure': 'WHO-DAS-2.0-12', 'timeFrame': '4 weeks', 'description': 'Change in qualify of life from baseline scores on the World Health Organization Disability Assessment Schedule, Version 2.0 after 4 weeks. Scores range from 12-60, with higher scores indicating a worse outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep']}, 'descriptionModule': {'briefSummary': "New methods for the treatment and support of Veterans experiencing sleep issues is critically needed. LEVEL's unique, targeted effects-based cannabis products provide a unique opportunity to study the therapeutic safety and efficacy of cannabigerol (a non-psychoactive cannabinoid) with a controlled dosage. Study participants will participate in an interventional, placebo-controlled, triple-blind pre-post study design. Participants will have a four-week run-in phase followed by an eight-week treatment phase with a CBG ProtabTM or placebo ProtabTM in a swallowable tablet form. During the study, participants will answer questions assessing their sleep, alcohol and drug use, and quality of life, among others. They will also wear a Fitbit Inspire 2 to collect biometric data."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Veteran status\n* MOS Sleep Problems Index II \\> 30\n* California resident\n* Participants must own their own smartphone device to use for the study. Devices must meet the following criteria:\n* Participants must be comfortable reading study instructions in English and communicating with study team in English\n* Be willing to commit to study dosing, completing evaluation instruments, and following study protocol activities.\n* If female and of childbearing potential, agree to use an effective form of birth control during study participation.\n\nExclusion Criteria:\n\n* If using sleep medications, medication and dosage have not been changed in the past month and will remain unchanged for the duration of the study\n* If using other psychotropic medications, medication and dosage have not been changed in the past 2 months, and will remain unchanged for the duration of the study\n* Prior observation that the prospective participant has stopped breathing or observed choking/gasping during their sleep\n* Previous diagnosis of sleep apnea (participant reported) without use of a CPAP (or similar PAP device) for at least the prior 4 weeks\n* Currently in a Cognitive Behavioral Therapy for Insomnia (CBTI) program\n* Women who are currently pregnant, trying to become pregnant, or breastfeeding\n* Currently using CBG on a regular basis\n* Participant has already participated in this study'}, 'identificationModule': {'nctId': 'NCT05088018', 'acronym': 'ECS21', 'briefTitle': 'Swallowable Cannabigerol Tablets for Sleep Quality In Veterans (Veterans Exploring Cannabigerol for Sleep)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Metta Medical, Inc'}, 'officialTitle': 'A Placebo-controlled, Triple-blind, Pre-post Interventional Study of Swallowable Cannabigerol Tablets on Sleep Quality in Veterans', 'orgStudyIdInfo': {'id': 'VetsECS21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Cannabigerol', 'description': '25 mg daily swallowable Cannabigerol tablets for 2 weeks, immediately followed by 50 mg daily swallowable Cannabigerol tablets for 2 weeks', 'interventionNames': ['Other: Cannabigerol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '25 mg daily swallowable placebo tablets for 2 weeks, immediately followed by 50 mg daily swallowable placebo tablets for 2 weeks', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Cannabigerol', 'type': 'OTHER', 'description': 'Cannabigerol is a non-psychoactive cannabinoid obtained from the cannabis plant.', 'armGroupLabels': ['Active Cannabigerol']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'A placebo form of the same swallowable tablet with no cannabigerol', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91789', 'city': 'Walnut', 'state': 'California', 'country': 'United States', 'facility': 'Virtual Site', 'geoPoint': {'lat': 34.02029, 'lon': -117.86534}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chris Emerson', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Veterans Cannabis Group', 'class': 'UNKNOWN'}, {'name': 'Curebase Inc.', 'class': 'INDUSTRY'}, {'name': 'Santa Cruz Veterans Alliance', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'CEO & Founder', 'investigatorFullName': 'Chris Emerson', 'investigatorAffiliation': 'Metta Medical, Inc'}}}}