Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-31 @ 1:16 AM
Study NCT ID:
NCT05188404
Status:
COMPLETED
Last Update Posted:
2025-06-18
First Post:
2021-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aging and Marijuana: Benefits, Effects, and Risks
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 326}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-17', 'studyFirstSubmitDate': '2021-12-10', 'studyFirstSubmitQcDate': '2021-12-27', 'lastUpdatePostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Blood Cannabinoids and Endocannabinoids', 'timeFrame': 'Baseline, 1-month', 'description': 'Quantitation of major and minor cannabinoids and endocannabinoids in blood; measure of whether cannabinoid levels change over time'}, {'measure': 'Change in Neurofilament Light', 'timeFrame': 'Baseline, 1-month', 'description': 'Quantitation of neuronal damage in blood; measure of whether damage change over time'}, {'measure': 'Change in Expectancies about Cannabis', 'timeFrame': 'Baseline, 1-month, 2 months, 3 months, 4 months', 'description': 'Self-report of whether opinions about the health effects of cannabis has improved, gotten worse, or stayed the same'}, {'measure': 'Change in Flanker Inhibitory Control and Attention task', 'timeFrame': 'Baseline, 1-month', 'description': 'Measure of whether inhibition has improved, gotten worse, or stayed the same'}], 'primaryOutcomes': [{'measure': 'Change in Patient Global Impression of Change', 'timeFrame': '1-month, 2 months, 3 months, 4 months', 'description': 'Self report of whether symptoms have improved, gotten worse, or stayed the same'}, {'measure': 'Change in FACT-Cog', 'timeFrame': 'Baseline, 1-month, 2 months, 3 months, 4 months', 'description': 'Self-report of whether cognitive function has improved, gotten worse, or stayed the same'}, {'measure': 'Change in Rey Auditory Verbal Learning Task', 'timeFrame': 'Baseline, 1-month', 'description': 'Test of whether working memory has improved, gotten worse, or stayed the same'}, {'measure': 'Balance Task', 'timeFrame': '1-month', 'description': 'Stability with eyes closed and eyes open'}, {'measure': 'Change in Activities Specific Balance Confidence Scale', 'timeFrame': 'Baseline, 1-month, 2 months, 3 months, 4 months', 'description': 'Self-report of whether confidence in balance has improved, gotten worse, or stayed the same'}], 'secondaryOutcomes': [{'measure': 'Change in Depression Anxiety Stress Scale', 'timeFrame': 'Baseline, 1-month, 2 months, 3 months, 4 months', 'description': 'Self-report of whether depression, anxiety and stress have improved, gotten worse, or stayed the same'}, {'measure': 'Change in PROMIS Sleep Disturbance', 'timeFrame': 'Baseline, 1-month, 2 months, 3 months, 4 months', 'description': 'Self-report of whether sleep quality has improved, gotten worse, or stayed the same'}, {'measure': 'Change in PROMIS Fatigue', 'timeFrame': 'Baseline, 1-month, 2 months, 3 months, 4 months', 'description': 'Measure of whether experience of fatigue has improved, gotten worse, or stayed the same'}, {'measure': 'Change in PROMIS Pain Interference', 'timeFrame': 'Baseline, 1-month, 2 months, 3 months, 4 months', 'description': 'Self-report of whether the extent to which pain interferes with daily life activities has improved, gotten worse, or stayed the same'}, {'measure': 'Change in pain Intensity past 7 days', 'timeFrame': 'Baseline, 1-month, 2 months, 3 months, 4 months', 'description': 'Self-report of whether intensity of pain has improved, gotten worse, or stayed the same'}, {'measure': 'Current Pain Intensity', 'timeFrame': '1-month', 'description': 'Self-reported intensity of pain right now'}, {'measure': 'Addiction Research Center Inventory Marijuana Survey', 'timeFrame': '1-month', 'description': 'Acute subjective effects of cannabis'}, {'measure': 'Drug Effects Questionnaire', 'timeFrame': '1-month', 'description': 'Acute subjective effects of cannabis'}, {'measure': 'Profile of Mood States', 'timeFrame': '1-month', 'description': 'Acute mood effects of cannabis'}, {'measure': 'Change in PROMIS Global Health', 'timeFrame': 'Baseline, 1-month, 2 months, 3 months, 4 months', 'description': 'Self-report of whether general health and functioning has improved, gotten worse, or stayed the same'}, {'measure': 'Change in Polypharmacy', 'timeFrame': 'Baseline, 1-month, 2 months, 3 months, 4 months', 'description': 'Measure of whether number and dosage of current medications has improved, gotten worse, or stayed the same'}, {'measure': 'Change in Online Timeline Follow-back Assessment', 'timeFrame': 'Baseline, 1-month, 2 months, 3 months, 4 months', 'description': '30-day retrospective report of substance use (cannabis, alcohol, other drugs); measure of whether substance use has improved, gotten worse, or stayed the same'}, {'measure': 'Change in Marijuana Consumption Questionnaire', 'timeFrame': 'Baseline, 1-month, 2 months, 3 months, 4 months', 'description': 'Self-report of whether frequency and quantity of cannabis use changes over time or stays the same'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cannabis Use']}, 'descriptionModule': {'briefSummary': 'Investigators will gather data on both the beneficial and harmful effects of edible cannabis of varying composition (THC-only vs. CBD-only vs. THC+CBD), and will examine the process by which older adult cannabis users decide what type of cannabis product is preferred.', 'detailedDescription': 'Older adults are currently the fastest growing group of cannabis users in the U.S, and are more likely to use cannabis for medicinal purposes (e.g., pain, trouble sleeping, depression/anxiety) than for recreational purposes, despite having little data to guide their decisions about what type of product to use. This project utilizes a patient-centered observational design to recruit and assess older adults who are interested in using cannabis compared to a control group who is not interested in cannabis use. Investigators will gather data on both the beneficial and harmful effects of edible cannabis of varying composition (THC-only vs. CBD-only vs. THC+CBD), and will examine the process by which older adult cannabis users decide what type of cannabis product is preferred.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Older adults experiencing problems with pain, sleep, depression or anxiety who either wish to use cannabis or who do not wish to cannabis', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 60 years of age\n* Able to provide informed consent\n* Cannabis Users: Must not currently use cannabis more than 7 times per month and not for pain, sleep, depression or anxiety in the past 6 months\n* Cannabis Non-users: Should NOT have used cannabis in the past year and have not used regularly (e.g., more than weekly) for more than one year in the past 20 years\n* Cannabis Users: Must be interested in using cannabis for at least one of the following complains: pain, sleep problems, depression, anxiety\n* Non-users: Must NOT be interested in using cannabis but have at least one of the following complaints: pain, sleep problems, depression, anxiety\n* Cannabis users: must be comfortable using edible cannabis and having a mobile laboratory (Dodge van) parked at their home\n* Female participants must be postmenopausal\n* Comfortable reading and writing in English\n* Planning to stay in the Boulder/Denver area for the next month\n* Must be comfortable with blood draws\n\nExclusion Criteria:\n\n* Blood alcohol level \\> 0 at screening (to sign consent form)\n* Report of other drug use (cocaine, opiates, methamphetamine) in the past 90 days or fail urine screen for any of these drugs\n* Past or current diagnosis of psychosis\n* Current use of antipsychotic medications\n* Heavy drinking; Alcohol Use Disorder Identification Test (AUDIT) test score \\>8\n* Inability/discomfort/unwillingness with getting in and out of the mobile laboratory van\n* History of vertigo or falls within the past six months'}, 'identificationModule': {'nctId': 'NCT05188404', 'acronym': 'AMBER', 'briefTitle': 'Aging and Marijuana: Benefits, Effects, and Risks', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Boulder'}, 'officialTitle': 'Cannabis Use Among Older Adults: Potential Risks and Benefits to an Aging Population', 'orgStudyIdInfo': {'id': '1R01AG066698', 'link': 'https://reporter.nih.gov/quickSearch/1R01AG066698', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cannabis Users', 'description': 'Older adults (60 and up) who report pain, sleep problems, and/or negative mood (anxiety and/or depression) and who desire to use cannabis for these issues (n=300)', 'interventionNames': ['Behavioral: Choice of cannabis product']}, {'label': 'Cannabis Non-users', 'description': 'Older adults (60 and up) who report pain, sleep problems, and/or negative mood (anxiety and/or depression) and do NOT desire to use cannabis for these issues (n=50)'}], 'interventions': [{'name': 'Choice of cannabis product', 'type': 'BEHAVIORAL', 'description': 'Participants choose and purchase their own cannabis product', 'armGroupLabels': ['Cannabis Users']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80309', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Boulder', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Boulder', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Angela Bryan', 'investigatorAffiliation': 'University of Colorado, Boulder'}}}}