Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-26 @ 4:19 PM
Study NCT ID:
NCT03567434
Status:
COMPLETED
Last Update Posted:
2024-09-24
First Post:
2018-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Alcohol and Neural Cardiovascular Control in Binge Drinkers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063425', 'term': 'Binge Drinking'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D000428', 'term': 'Alcohol Drinking'}, {'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000431', 'term': 'Ethanol'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jason_carter1@baylor.edu', 'phone': '254-710-4499', 'title': 'Dr. Jason Carter', 'organization': 'Baylor University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'On average 1 to 2 months following initial laboratory testing session', 'description': 'Participants were monitored for minor and serious adverse events throughout the protocol. Participants were not at risk for all-cause mortality and were not monitored for all-cause mortality. All participants were young healthy (male/female) adults and were screened for serious disorders that may predispose them towards unanticipated adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Fluid Control', 'description': 'All participants received both a binge alcohol dose (0.85g/kg for females, 1.0g/kg for males) and a fluid control drink (i.e., juice) of the same volume of fluid as the alcohol condition. These conditions were provided in a randomized, crossover design, and were separated by 1-month washout.', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 0, 'otherNumAffected': 2, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Alcohol', 'description': 'All participants received both a binge alcohol dose (0.85g/kg for females, 1.0g/kg for males) and a fluid control drink (i.e., juice) of the same volume of fluid as the alcohol condition. These conditions were provided in a randomized, crossover design, and were separated by 1-month washout.', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 0, 'otherNumAffected': 1, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Presyncope in response to venipuncture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sympathetic Nerve Activity Burst Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluid Control', 'description': 'All participants received both a binge alcohol dose (0.85g/kg for females, 1.0g/kg for males) and a fluid control drink (i.e., juice) of the same volume of fluid as the alcohol condition. These conditions were provided in a randomized, crossover design, and were separated by 1-month washout.'}, {'id': 'OG001', 'title': 'Alcohol', 'description': 'All participants received both a binge alcohol dose (0.85g/kg for females, 1.0g/kg for males) and a fluid control drink (i.e., juice) of the same volume of fluid as the alcohol condition. These conditions were provided in a randomized, crossover design, and were separated by 1-month washout.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'spread': '9', 'groupId': 'OG000'}, {'value': '20', 'spread': '8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.283', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The original hypothesis was that resting MSNA burst frequency would be higher the morning after evening binge alcohol when compared to fluid control condition. A p-value of \\< 0.05 was used for significance.', 'groupDescription': 'Statistical analysis on Burst Frequency (Burst/Min)', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The original hypothesis was that resting MSNA burst frequency would be higher the morning after evening binge alcohol when compared to fluid control condition. A p-value of \\< 0.05 was used for significance.'}, {'pValue': '0.920', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The original hypothesis was that resting MSNA burst frequency would be higher the morning after evening binge alcohol when compared to fluid control condition. A p-value of \\< 0.05 was used for significance.', 'groupDescription': 'Statistical analysis on Burst Incidence (Burst/100hb)', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The original hypothesis was that resting MSNA burst incidence would be higher the morning after evening binge alcohol when compared to fluid control condition. A p-value of \\< 0.05 was used for significance.'}], 'paramType': 'MEAN', 'timeFrame': '1 month', 'description': 'Direct recordings of muscle sympathetic nerve activity (MSNA) from the peroneal nerve using a microelectrode.', 'unitOfMeasure': 'Burst/Min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '26 total participants were analyzed for primary outcome measures that completed both arms (fluid control vs. alcohol) of the study, using a randomized crossover design.'}, {'type': 'PRIMARY', 'title': 'Sympathetic Nerve Activity Burst Incidence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluid Control', 'description': 'All participants received both a binge alcohol dose (0.85g/kg for females, 1.0g/kg for males) and a fluid control drink (i.e., juice) of the same volume of fluid as the alcohol condition. These conditions were provided in a randomized, crossover design, and were separated by 1-month washout.'}, {'id': 'OG001', 'title': 'Alcohol', 'description': 'All participants received both a binge alcohol dose (0.85g/kg for females, 1.0g/kg for males) and a fluid control drink (i.e., juice) of the same volume of fluid as the alcohol condition. These conditions were provided in a randomized, crossover design, and were separated by 1-month washout.'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'spread': '16', 'groupId': 'OG000'}, {'value': '31', 'spread': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month', 'description': "Direct recordings of muscle sympathetic nerve activity (MSNA) from the peroneal nerve using a microelectrode. Burst incidence is calculated as the number of sympathetic bursts per 100 heartbeats. This measure takes into account varying heart rates on sympathetic activity by normalizing to each individual's heartbeat. Higher calculated number equates to higher sympathetic activity.", 'unitOfMeasure': 'burst/100 heart beats', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '26 total participants were analyzed for primary outcome measures that completed both arms (fluid control vs. alcohol) of the study, using a randomized crossover design.'}, {'type': 'SECONDARY', 'title': 'Spontaneous Sympathetic Baroreflex Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluid Control', 'description': 'All participants received both a binge alcohol dose (0.85g/kg for females, 1.0g/kg for males) and a fluid control drink (i.e., juice) of the same volume of fluid as the alcohol condition. These conditions were provided in a randomized, crossover design, and were separated by 1-month washout.'}, {'id': 'OG001', 'title': 'Alcohol', 'description': 'All participants received both a binge alcohol dose (0.85g/kg for females, 1.0g/kg for males) and a fluid control drink (i.e., juice) of the same volume of fluid as the alcohol condition. These conditions were provided in a randomized, crossover design, and were separated by 1-month washout.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2', 'spread': '1', 'groupId': 'OG000'}, {'value': '-2', 'spread': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.888', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The original hypothesis was that sympathetic baroreflex sensitivity would be blunted the morning after evening binge alcohol when compared to fluid control condition. A p-value of \\< 0.05 was used for significance.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The original hypothesis was that sympathetic baroreflex sensitivity would be blunted the morning after evening binge alcohol when compared to fluid control condition. A p-value of \\< 0.05 was used for significance.'}], 'paramType': 'MEAN', 'timeFrame': '1 month', 'description': 'The linear relationship between beat-to-beat blood pressure and sympathetic nerve activity expressed as bursts/100 heart beats. Sympathetic baroreflex sensitivity is determined using the slope of the weighted linear regression of diastolic blood pressure and MSNA burst incidence. Diastolic blood pressure values of individual cardiac cycles were binned into 3 mmHg intervals, and the MSNA burst incidence was determined and subsequently plotted against corresponding diastolic blood pressure bins.', 'unitOfMeasure': 'MSNA Bursts/100 heart beats/mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '11 total participants were analyzed for the secondary outcome measure that completed both arms of the study (fluid control vs. alcohol), with a randomized crossover design.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Nocturnal Blood Pressure Dip', 'timeFrame': '1 month', 'description': 'Change in nocturnal blood pressure during sleep when compared to evening/morning wakefulness.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Sleep Quality', 'timeFrame': '1 month', 'description': 'Polysomnography will be used to determine the quality of sleep, with a primary focus on the apnea-hypopnea index.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Sympathetic Reactivity', 'timeFrame': '1 month', 'description': 'The change in muscle sympathetic nerve activity during an acute laboratory stressor.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fluid Control, Then Alcohol', 'description': 'Participants first received a fluid control drink (i.e., juice) of the same volume of fluid as the alcohol condition. After at least a one-month washout period, they then received the alcohol condition.\n\nAlcohol vs. Placebo: Using a randomized, cross-over design, all subjects will consume evening alcohol (and a fluid-control placebo) in a dose that mimics binge drinking.'}, {'id': 'FG001', 'title': 'Alcohol, Then Fluid Control', 'description': 'Participants first received the alcohol condition with 95% ethanol and fruit juice (1:3 ratio). After at least a one-month washout period, they then received the fluid control condition with a volume fluid match.\n\nAlcohol vs. Placebo: Using a randomized, cross-over design, all subjects will consume evening alcohol (and a fluid-control placebo) in a dose that mimics binge drinking.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'Completed Test 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'Completed Test 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Participants were recruited by word-of-mouth and advertisements. 169 participants were screened for eligibility.', 'preAssignmentDetails': '38/169 participants were randomized. Of the 131 that were not randomized 100 did not meet inclusion criteria or did not consent and 31 were lost to follow-up/drop out.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Fluid Control, Then Alcohol', 'description': 'Participants first received a fluid control drink (i.e., juice) of the same volume of fluid as the alcohol condition. After at least a one-month washout period, they then received the alcohol condition.\n\nAlcohol vs. Placebo: Using a randomized, cross-over design, all subjects will consume evening alcohol (and a fluid-control placebo) in a dose that mimics binge drinking.'}, {'id': 'BG001', 'title': 'Alcohol, Then Fluid Control', 'description': 'Participants first received the alcohol condition with 95% ethanol and fruit juice (1:3 ratio). After at least a one-month washout period, they then received the fluid control condition with a volume fluid match.\n\nAlcohol vs. Placebo: Using a randomized, cross-over design, all subjects will consume evening alcohol (and a fluid-control placebo) in a dose that mimics binge drinking.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-02-21', 'size': 457224, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2024-06-26T17:13', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-29', 'studyFirstSubmitDate': '2018-05-24', 'resultsFirstSubmitDate': '2024-06-27', 'studyFirstSubmitQcDate': '2018-06-12', 'lastUpdatePostDateStruct': {'date': '2024-09-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-06', 'studyFirstPostDateStruct': {'date': '2018-06-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Nocturnal Blood Pressure Dip', 'timeFrame': '1 month', 'description': 'Change in nocturnal blood pressure during sleep when compared to evening/morning wakefulness.'}, {'measure': 'Sleep Quality', 'timeFrame': '1 month', 'description': 'Polysomnography will be used to determine the quality of sleep, with a primary focus on the apnea-hypopnea index.'}, {'measure': 'Sympathetic Reactivity', 'timeFrame': '1 month', 'description': 'The change in muscle sympathetic nerve activity during an acute laboratory stressor.'}], 'primaryOutcomes': [{'measure': 'Sympathetic Nerve Activity Burst Frequency', 'timeFrame': '1 month', 'description': 'Direct recordings of muscle sympathetic nerve activity (MSNA) from the peroneal nerve using a microelectrode.'}, {'measure': 'Sympathetic Nerve Activity Burst Incidence', 'timeFrame': '1 month', 'description': "Direct recordings of muscle sympathetic nerve activity (MSNA) from the peroneal nerve using a microelectrode. Burst incidence is calculated as the number of sympathetic bursts per 100 heartbeats. This measure takes into account varying heart rates on sympathetic activity by normalizing to each individual's heartbeat. Higher calculated number equates to higher sympathetic activity."}], 'secondaryOutcomes': [{'measure': 'Spontaneous Sympathetic Baroreflex Sensitivity', 'timeFrame': '1 month', 'description': 'The linear relationship between beat-to-beat blood pressure and sympathetic nerve activity expressed as bursts/100 heart beats. Sympathetic baroreflex sensitivity is determined using the slope of the weighted linear regression of diastolic blood pressure and MSNA burst incidence. Diastolic blood pressure values of individual cardiac cycles were binned into 3 mmHg intervals, and the MSNA burst incidence was determined and subsequently plotted against corresponding diastolic blood pressure bins.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Binge Drinking']}, 'referencesModule': {'references': [{'pmid': '39119705', 'type': 'DERIVED', 'citation': 'Bigalke JA, Greenlund IM, Solis-Montenegro TX, Durocher JJ, Joyner MJ, Carter JR. Binge Alcohol Consumption Elevates Sympathetic Transduction to Blood Pressure: A Randomized Controlled Trial. Hypertension. 2024 Oct;81(10):2140-2151. doi: 10.1161/HYPERTENSIONAHA.124.23416. Epub 2024 Aug 9.'}, {'pmid': '34015116', 'type': 'DERIVED', 'citation': 'Greenlund IM, Bigalke JA, Tikkanen AL, Durocher JJ, Smoot CA, Carter JR. Evening binge alcohol disrupts cardiovagal tone and baroreflex function during polysomnographic sleep. Sleep. 2021 Nov 12;44(11):zsab130. doi: 10.1093/sleep/zsab130.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the impact of evening alcohol consumption on sympathetic activity and baroreflex function in binge drinkers. Our central hypothesis is that evening binge alcohol consumption will lead to sympathetic overactivity and blunted baroreflex function.', 'detailedDescription': 'This study will recruit male and female binge drinkers who will participate in a randomized, cross-over, double-blind, placebo-based study to examine the impact of an evening of alcohol vs. placebo/fluid-control on autonomic and cardiovascular control at night and the subsequent morning. The study will utilize established techniques for assessing sleep (polysomnography) and autonomic/cardiovascular control (microneurography, beat-to-beat finger plethysmography, electrocardiogram, etc.). All subjects will undergo a familiarization night in the sleep laboratory prior to their first randomized test session with either alcohol or placebo/fluid-control. Both men and women will be tested to address a secondary aim of determining the impact of sex (male vs. female) and ovarian cycle (early follicular vs. midluteal phase) on sympathetic neural responsiveness to evening alcohol in binge drinkers. Finally, as a tertiary/exploratory aim, participants that have a respiratory disturbance index of ≥5 episodes per hour during the alcohol treatment will be asked to consider one additional overnight session where they will be randomly assigned to either continuous positive airway pressure (CPAP) or sham-CPAP for one additional night of evening alcohol consumption.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women age 21 - 40 years\n* Binge drinkers as defined by a pattern of consuming ≥4 drinks if female (≥5 drinks if males) in ≤ 2 hours on more than one occasion within the past 6 months, and at least once in the past 30 days. The National Institute of Alcohol Abuse and Alcoholism (NIAAA) definition of a "drink" will be used.\n* Women must be eumenorrheic and premenopausal with regular and consistent menstrual cycles (i.e., \\~25-30 days ovarian/uterine cycles that include 2-7 days of menstruation)\n* Willingness to abstain from exercise and caffeine at least 12 hours prior to any autonomic and cardiovascular testing, and abstain from alcohol 24 hours prior to any autonomic and cardiovascular testing (unless experimentally administered).\n\nExclusion Criteria:\n\n* Body mass index ≥ 35 kg/m2\n* Smokers\n* A physician diagnosis of diabetes\n* Pregnancy\n* Taking any cardiovascular medications\n* Severe obstructive sleep apnea as determined by an apnea-hypopnea index of ≥ 30 episodes per hour\n* Moderate-to-severe Alcohol Use Disorder (AUD) as determined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-V)\n* Individuals suspected to have mutant alcohol dehydrogenase 2 (ALDH2) isoenzyme as determined using a validated flushing questionnaire\n* Women using hormonal contraceptives (i.e., oral, intrauterine, etc.) in the prior 6 months'}, 'identificationModule': {'nctId': 'NCT03567434', 'briefTitle': 'Alcohol and Neural Cardiovascular Control in Binge Drinkers', 'organization': {'class': 'OTHER', 'fullName': 'Baylor University'}, 'officialTitle': 'Randomized, Double-Blind, Placebo-Based Study to Determine Effect of Evening Alcohol on Sympathetic Neural Activity and Baroreflex Function in Binge Drinkers', 'orgStudyIdInfo': {'id': 'JC080420-FC'}, 'secondaryIdInfos': [{'id': '1R01AA024892-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01AA024892-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Fluid Control', 'description': 'Participants first received a fluid control drink (i.e., juice) of the same volume of fluid as the alcohol condition. After at least a one-month washout period, they then received the alcohol condition.', 'interventionNames': ['Other: Alcohol vs. Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Alcohol', 'description': 'Participants first received the alcohol condition with 95% ethanol and fruit juice (1:3 ratio). After at least a one-month washout period, they then received the fluid control condition with a volume fluid match.', 'interventionNames': ['Other: Alcohol vs. Placebo']}], 'interventions': [{'name': 'Alcohol vs. Placebo', 'type': 'OTHER', 'otherNames': ['Ethanol'], 'description': 'Using a randomized, cross-over design, all subjects will consume evening alcohol (and a fluid-control placebo) in a dose that mimics binge drinking.', 'armGroupLabels': ['Alcohol', 'Fluid Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59717', 'city': 'Bozeman', 'state': 'Montana', 'country': 'United States', 'facility': 'Montana State University', 'geoPoint': {'lat': 45.67965, 'lon': -111.03856}}], 'overallOfficials': [{'name': 'Jason Carter', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The scientific field of neural cardiovascular control in humans does not, at present, have a common data repository that would be applicable to this project. However, all data will be stored on secure University server in a de-identified manner, and investigators will make raw data available to individuals, groups, and organizations upon request and when appropriate.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Chicago', 'class': 'OTHER'}, {'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}