Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2025-12-26 @ 3:52 AM
Study NCT ID:
NCT05511818
Status:
COMPLETED
Last Update Posted:
2023-11-22
First Post:
2022-08-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Radicle Rest: A Study of Cannabinoids on Sleep and Health Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020447', 'term': 'Parasomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'The investigator is blinded to the participants assigned study products. Participants are blinded to the study product they received.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be stratified based on gender at birth then randomized to one of the study arms'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2679}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-20', 'studyFirstSubmitDate': '2022-08-10', 'studyFirstSubmitQcDate': '2022-08-22', 'lastUpdatePostDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in sleep disturbance', 'timeFrame': '4 weeks', 'description': 'Mean difference in sleep disturbance score as assessed by Patient Reported Outcome Measurement System (PROMIS) Sleep Disturbance Short Form 8A (scale 8-40; where higher scores correspond to greater sleep disturbance)'}], 'secondaryOutcomes': [{'measure': 'Change in overall well-being', 'timeFrame': '4 weeks', 'description': 'Mean difference in well-being score as assessed by World Health Organization 5 (WHO 5; scale 0-25; with 0 representing the worst imaginable well-being and 25 representing the best imaginable well-being)'}, {'measure': 'Change in overall quality of life (QOL)', 'timeFrame': '4 weeks', 'description': 'Mean difference in QOL score as assessed by Kemp QOL (scale 1-7; with 1 representing very poor QOL and 7 representing excellent QOL)'}, {'measure': 'Change in anxiety', 'timeFrame': '4 weeks', 'description': 'Mean difference in anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety)'}, {'measure': 'Change in pain', 'timeFrame': '4 weeks', 'description': 'Mean difference in pain score as assessed by the Pain on average, Enjoyment of life, and General activity score (PEG; scale 0-10; with 0 representing no pain and 10 representing the worst pain imaginable that completely interferes with enjoyment of life and general activities)'}, {'measure': 'Change in stress', 'timeFrame': '4 weeks', 'description': 'Mean difference in stress score as assessed by PROMIS Stress 4A (scale 4-20; where higher scores correspond to more severe stress)'}, {'measure': 'Change in fatigue', 'timeFrame': '4 weeks', 'description': 'Mean difference in fatigue score as assessed by PROMIS Fatigue 4A (scale 4-20; where higher scores correspond to more severe fatigue)'}, {'measure': 'Minimal clinically important difference (MCID) in sleep disturbance', 'timeFrame': '4 weeks', 'description': 'Likelihood of achieving a MCID in sleep disturbance, as measured by PROMIS Sleep Disturbance Short Form 8A (scale 8-40; where higher scores correspond to greater sleep disturbance)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep', 'Sleep Disturbance', 'Sleep Disorder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://radiclescience.com', 'label': 'Radicle Science, Inc'}]}, 'descriptionModule': {'briefSummary': 'A randomized, blinded, placebo-controlled, direct-to-consumer study assessing the impact of plant derived cannabinoids on sleep and overall health outcomes', 'detailedDescription': 'This is a randomized, blinded, placebo-controlled study conducted with up to 300 adult participants per study arm, age 21 and older and residing in the United States.\n\nEligible participants will (1) endorse a desire for better sleep, (2) indicate a willingness to refrain from taking cannabinoids during the study period, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study.\n\nParticipants with known liver disease, heavy drinkers, and those who are pregnant, trying to become pregnant, or breastfeeding will be excluded. Those taking medications that warn against grapefruit consumption will be excluded.\n\nSelf-reported data are collected electronically from eligible participants over 5 weeks. Participant reports of health indicators will be collected during baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '105 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 21 years of age and older\n* Resides in the United States\n* Endorses a desire for better sleep\n* Selects sleep as a primary reason for taking a cannabinoid product\n* Expresses a willingness to refrain from taking any non-study cannabinoid product (i.e. CBD, CBG, CBC, CBN, THC) for the duration of participant engagement (5 weeks)\n* Expresses an interest in taking a study product and not knowing the product identity until the end of the study\n\nExclusion Criteria:\n\n* Pregnant, trying to become pregnant, or breastfeeding\n* Reports a diagnosis of liver disease\n* Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)\n* Unable to read and understand English\n* Lack of reliable daily access to the internet\n* Reports taking any medication that warns against grapefruit consumption'}, 'identificationModule': {'nctId': 'NCT05511818', 'briefTitle': 'Radicle Rest: A Study of Cannabinoids on Sleep and Health Outcomes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Radicle Science'}, 'officialTitle': 'Radicle™ Rest: A Randomized, Blinded, Placebo-controlled, Direct-to-consumer Study Assessing the Impact of Plant Derived Cannabinoids on Sleep and Overall Health Outcomes', 'orgStudyIdInfo': {'id': 'RADX-22D03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Control 1', 'description': 'Rest Product Form 1 - control', 'interventionNames': ['Dietary Supplement: Rest Study Product Usage']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Control 2', 'description': 'Rest Product Form 2 - control', 'interventionNames': ['Dietary Supplement: Rest Study Product Usage']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Control 3', 'description': 'Rest Product Form 3 - control', 'interventionNames': ['Dietary Supplement: Rest Study Product Usage']}, {'type': 'EXPERIMENTAL', 'label': 'Active Product 1.1', 'description': 'Rest Product Form 1 - active product 1', 'interventionNames': ['Dietary Supplement: Rest Study Product Usage']}, {'type': 'EXPERIMENTAL', 'label': 'Active Product 1.2', 'description': 'Rest Product Form 1 - active product 2', 'interventionNames': ['Dietary Supplement: Rest Study Product Usage']}, {'type': 'EXPERIMENTAL', 'label': 'Active Product 1.3', 'description': 'Rest Product Form 1 - active product 3', 'interventionNames': ['Dietary Supplement: Rest Study Product Usage']}, {'type': 'EXPERIMENTAL', 'label': 'Active Product 1.4', 'description': 'Rest Product Form 1 - active product 4', 'interventionNames': ['Dietary Supplement: Rest Study Product Usage']}, {'type': 'EXPERIMENTAL', 'label': 'Active Product 2.1', 'description': 'Rest Product Form 2 - active product 1', 'interventionNames': ['Dietary Supplement: Rest Study Product Usage']}, {'type': 'EXPERIMENTAL', 'label': 'Active Product 2.2', 'description': 'Rest Product Form 2 - active product 2', 'interventionNames': ['Dietary Supplement: Rest Study Product Usage']}, {'type': 'EXPERIMENTAL', 'label': 'Active Product 3.1', 'description': 'Rest Product Form 3 - active product 1', 'interventionNames': ['Dietary Supplement: Rest Study Product Usage']}, {'type': 'EXPERIMENTAL', 'label': 'Active Product 3.2', 'description': 'Rest Product Form 3 - active product 2', 'interventionNames': ['Dietary Supplement: Rest Study Product Usage']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Control 4', 'description': 'Rest Product Form 4 - control', 'interventionNames': ['Dietary Supplement: Rest Study Product Usage']}, {'type': 'EXPERIMENTAL', 'label': 'Active Product 4', 'description': 'Rest Product Form 4 - active product 1', 'interventionNames': ['Dietary Supplement: Rest Study Product Usage']}], 'interventions': [{'name': 'Rest Study Product Usage', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will use their Radicle Rest study product as directed for a period of 4 weeks.', 'armGroupLabels': ['Active Product 1.1', 'Active Product 1.2', 'Active Product 1.3', 'Active Product 1.4', 'Active Product 2.1', 'Active Product 2.2', 'Active Product 3.1', 'Active Product 3.2', 'Active Product 4', 'Placebo Control 1', 'Placebo Control 2', 'Placebo Control 3', 'Placebo Control 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92014', 'city': 'Del Mar', 'state': 'California', 'country': 'United States', 'facility': 'Radicle Science, Inc', 'geoPoint': {'lat': 32.95949, 'lon': -117.26531}}], 'overallOfficials': [{'name': 'Emily K. Pauli, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radicle Science Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will not be shared with researchers outside of Radicle Collaborators on this study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radicle Science', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}