Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-03-06 @ 12:34 AM
Study NCT ID:
NCT03096860
Status:
COMPLETED
Last Update Posted:
2017-10-13
First Post:
2017-03-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Concurrent Hookah and Alcohol Consumption on Smoking Topography and Toxicant Exposure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000428', 'term': 'Alcohol Drinking'}, {'id': 'D000073867', 'term': 'Water Pipe Smoking'}], 'ancestors': [{'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000073868', 'term': 'Pipe Smoking'}, {'id': 'D012907', 'term': 'Smoking'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D000431', 'term': 'Ethanol'}, {'id': 'D004467', 'term': 'Economics'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-11', 'studyFirstSubmitDate': '2017-03-20', 'studyFirstSubmitQcDate': '2017-03-24', 'lastUpdatePostDateStruct': {'date': '2017-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total volume smoke inhaled', 'timeFrame': 'up to 2 hours', 'description': 'hookah topography'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcohol Use, Unspecified', 'Hookah Smoking']}, 'referencesModule': {'references': [{'pmid': '30820567', 'type': 'DERIVED', 'citation': 'Leavens ELS, Morgan TL, Brett EI, Patzkowsky K, Son J, Molina N, Eissenberg T, Shihadeh A, Leffingwell TR, Wagener TL. Concurrent Alcohol Use and Waterpipe Tobacco Smoking: Smoking Topography, Toxicant Exposure, and Abuse Liability. Nicotine Tob Res. 2020 Feb 6;22(2):280-287. doi: 10.1093/ntr/ntz032.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the current study is to investigate in a prospective randomized cross-over trial, the impact of alcohol versus a placebo drink on smoking behavior and topography (duration and frequency of puffing), abuse liability, and toxicity. It is hypothesized that drinking alcohol before smoking will be associated with longer puffs and shorter duration between puffs and greater abuse liability and toxicity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Report using hookah at least 1 time per month over the past 6 months\n2. Are at least 21 years old\n3. Speak and understand English\n4. Do not currently suffer from lung disease including asthma, CF, or COPD\n5. Do not currently suffer from heart disease\n6. Are not currently pregnant or breast-feeding or have plans to become pregnant or begin breast-feeding at any point during the study\n7. No current, regular use of \\>5 cigarettes or other tobacco products (e.g., e-cig, cigar, etc.) per month.\n8. No current marijuana use \\> 5 times per month\n9. No use of illicit drugs during the past 30 days\n10. willing to provide informed consent and abstain from all tobacco, nicotine, and marijuana use for at least 12 hours and abstain from alcohol for at least 24 hours prior to each of the two sessions\n11. Live within 25 miles of the study location.\n12. Have a friend who is eligible and willing to participate.\n13. Consume 2 or more or one or more drinks per episode for men and women, respectively\n14. Drink alcohol at least one time per week\n15. Not currently be seeking treatment for alcohol use\n16. Able to answer at least two hookah-specific screening questions from the screener.\n\n \\-\n\nExclusion Criteria:\n\n1. Hookah use less than one time per month over the past 6 months\n2. Under the age of 21\n3. Unwilling to abstain from alcohol for 24 hours and tobacco and nicotine products 12 hours prior to each study visit\n4. Live more than 25 miles from the study location\n5. Pregnant or breast feeding or plan to become pregnant or begin breast feeding at any point in the study -'}, 'identificationModule': {'nctId': 'NCT03096860', 'briefTitle': 'Effect of Concurrent Hookah and Alcohol Consumption on Smoking Topography and Toxicant Exposure', 'organization': {'class': 'OTHER', 'fullName': 'Oklahoma State University'}, 'officialTitle': 'Effect of Concurrent Hookah and Alcohol Consumption on Smoking Topography and Toxicant Exposure', 'orgStudyIdInfo': {'id': 'NIH/NIDA F31 DA04252'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alcohol consumption and hookah', 'interventionNames': ['Other: Active alcohol consumption']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo consumption and hookah', 'interventionNames': ['Other: Placebo consumption']}], 'interventions': [{'name': 'Active alcohol consumption', 'type': 'OTHER', 'description': 'Comparison of alcohol consumption vs. placebo consumption and hookah smoking.', 'armGroupLabels': ['Alcohol consumption and hookah']}, {'name': 'Placebo consumption', 'type': 'OTHER', 'description': 'Comparison of alcohol consumption vs. placebo consumption and hookah smoking.', 'armGroupLabels': ['Placebo consumption and hookah']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'The Oklahoma Tobacco Research Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oklahoma State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Oklahoma', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Eleanor Leavens', 'investigatorAffiliation': 'Oklahoma State University'}}}}