Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2025-12-29 @ 3:18 PM
Study NCT ID:
NCT01096303
Status:
COMPLETED
Last Update Posted:
2017-05-15
First Post:
2010-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Marijuana Used on Lung Function in Persons With Chronic Obstructive Pulmonary Disease (COPD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D008385', 'term': 'Marijuana Smoking'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000074609', 'term': 'Marijuana Use'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000073847', 'term': 'Smoking, Non-Tobacco Products'}, {'id': 'D012907', 'term': 'Smoking'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-12', 'studyFirstSubmitDate': '2010-03-24', 'studyFirstSubmitQcDate': '2010-03-30', 'lastUpdatePostDateStruct': {'date': '2017-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Obstructive limitation in pulmonary function test', 'timeFrame': '1 year', 'description': 'Comparison on the severity of obstruction among both groups'}], 'secondaryOutcomes': [{'measure': 'Decreased diffusion capacity for carbon monoxide', 'timeFrame': '1 year', 'description': 'Comparison on the severity of decreased DLco among groups.'}, {'measure': 'Airtrapping', 'timeFrame': '1 year', 'description': 'Comparison on the severity of air-trapping by pulmonary function testing among groups.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD', 'pulmonary function', 'tobacco and marihuana smoking'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'The main hypothesis is that persons that smoke or smoked tobacco and marihuana have worsen lung function as compared with persons that only smoke or smoked tobacco.', 'detailedDescription': 'We will follow persons with already diagnosed COPD (chronic bronchitis and/or emphysema). Obtain their smoking history: tobacco and marihuana and review their pulmonary function study results. Then we are planning to compare both groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '25 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'COPD patients recruited in pulmonary clinic.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* COPD patients former or current tobacco smokers\n* COPD patients former or current tobacco and marihuana smokers\n\nExclusion Criteria:\n\n* History of COPD without pulmonary function testing\n* Refusal to provide smoking or marihuana used history'}, 'identificationModule': {'nctId': 'NCT01096303', 'briefTitle': 'Effects of Marijuana Used on Lung Function in Persons With Chronic Obstructive Pulmonary Disease (COPD)', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Effects of Marijuana Smoking on Pulmonary Function in Patients With COPD', 'orgStudyIdInfo': {'id': 'HSC-MS-09-0362'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COPD tobacco and/or marihuana users', 'description': 'COPD patients with history of tobacco and/or marihuana smoking.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '77026', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Lyndon B Johnson General Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas- Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Rosa M Estrada-Y-Martin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor - I/M Pulmonary and Critical Care', 'investigatorFullName': 'Rosa Estrada Y Martin', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}