Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT04596267
Status:
TERMINATED
Last Update Posted:
2023-12-04
First Post:
2020-10-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pitolisant Effects on Alcohol Self-Administration in Heavy Drinkers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}, {'id': 'D000428', 'term': 'Alcohol Drinking'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C516975', 'term': 'pitolisant'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'eric.devine@bmc.org', 'phone': '617-418-7888', 'title': 'Dr. Eric Devine', 'organization': 'Boston Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Recruitment was impacted by COVID-19 restrictions on human subject research, leading to a smaller number of subjects analyzed than planned. This study start date was also delayed due to problems securing the medication supply.'}}, 'adverseEventsModule': {'timeFrame': 'Up to 48 Days', 'description': 'The primary risks of this study were risks related to taking study medication, loss of confidentiality, discomfort with study procedures, overconsumption of alcohol, and interference with efforts for recovery from alcohol use disorder. These risks were adequately minimized by study design and adherence to the study protocol.', 'eventGroups': [{'id': 'EG000', 'title': 'Pitolisant', 'description': 'This is a within subjects design study in which each subject receives both study drug and placebo. Subjects received a dose of 8.9 mg (two 4.45 mg pills) of pitolisant once daily over a 7-day period and a dose of 17.8 mg (one 17.8 mg pill) of pitolisant once daily over a 5-day period before the first alcohol self-administration trial.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 2, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'This is a within subjects design study in which each subject receives both study drug and placebo. Subjects in this group received 12 days of matched placebo before the first alcohol self-administration trial.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 2, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Bright yellow urine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased Thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Left Ankle Pain', 'notes': 'Due to sprained ankle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right knee contusion with abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Alcohol Consumption in Alcohol Self-Administration Trials', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pitolisant', 'description': 'Subjects received 12 days of Pitolisant before the alcohol self-administration trial.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 12 days of placebo before the alcohol self-administration trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '67.214', 'spread': '25.759', 'groupId': 'OG000'}, {'value': '66.786', 'spread': '15.369', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2.6 hours', 'description': 'Alcohol consumption will be measured by using a graduated cylinder to determine the amount of alcohol given to the subject that was not consumed. This outcome will be measured as standard drink units (SDU). A standard drink contains approximately 0.6 fluid ounces of pure alcohol. Lower SDUs are favorable.', 'unitOfMeasure': 'Total SDUs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 9 subjects were randomized and 7 completed.'}, {'type': 'PRIMARY', 'title': 'Alcohol Consumption (BAC): Observation Period, Minute 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pitolisant', 'description': 'Subjects received 12 days of Pitolisant before the alcohol self-administration trial.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 12 days of placebo before the alcohol self-administration trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.034', 'spread': '0.005', 'groupId': 'OG000'}, {'value': '0.033', 'spread': '0.010', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 minute', 'description': 'Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable', 'unitOfMeasure': 'Grams of alcohol/210 Liters of breath', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 9 subjects were randomized and 7 completed.'}, {'type': 'PRIMARY', 'title': 'Alcohol Consumption (BAC): Observation Period, Minute 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pitolisant', 'description': 'Subjects received 12 days of Pitolisant before the alcohol self-administration trial.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 12 days of placebo before the alcohol self-administration trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.038', 'spread': '0.009', 'groupId': 'OG000'}, {'value': '0.0364', 'spread': '0.011', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 minute', 'description': 'Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable.', 'unitOfMeasure': 'Grams of alcohol/210 Liters of breath', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 9 subjects were randomized and 7 completed.'}, {'type': 'PRIMARY', 'title': 'Alcohol Consumption (BAC): Observation Period, Minute 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pitolisant', 'description': 'Subjects received 12 days of Pitolisant before the alcohol self-administration trial.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 12 days of placebo before the alcohol self-administration trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.037', 'spread': '0.003', 'groupId': 'OG000'}, {'value': '0.034', 'spread': '0.009', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 minute', 'description': 'Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable.', 'unitOfMeasure': 'Grams of alcohol/210 Liters of breath', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 9 subjects were randomized and 7 completed.'}, {'type': 'PRIMARY', 'title': 'Alcohol Consumption (BAC): Observation Period, Minute 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pitolisant', 'description': 'Subjects received 12 days of Pitolisant before the alcohol self-administration trial.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 12 days of placebo before the alcohol self-administration trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.033', 'spread': '0.006', 'groupId': 'OG000'}, {'value': '0.031', 'spread': '0.006', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 minute', 'description': 'Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable.', 'unitOfMeasure': 'Grams of alcohol/210 Liters of breath', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 9 subjects were randomized and 7 completed.'}, {'type': 'PRIMARY', 'title': 'Alcohol Consumption (BAC): Self-administration Block 1, Minute 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pitolisant', 'description': 'Subjects received 12 days of Pitolisant before the alcohol self-administration trial.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 12 days of placebo before the alcohol self-administration trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.069', 'spread': '0.046', 'groupId': 'OG000'}, {'value': '0.063', 'spread': '0.033', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 minute', 'description': 'Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable.', 'unitOfMeasure': 'Grams of alcohol/210 Liters of breath', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 9 subjects were randomized and 7 completed.'}, {'type': 'PRIMARY', 'title': 'Alcohol Consumption (BAC): Self-administration Block 1, Minute 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pitolisant', 'description': 'Subjects received 12 days of Pitolisant before the alcohol self-administration trial.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 12 days of placebo before the alcohol self-administration trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.072', 'spread': '0.037', 'groupId': 'OG000'}, {'value': '0.047', 'spread': '0.021', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 minute', 'description': 'Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable.', 'unitOfMeasure': 'Grams of alcohol/210 Liters of breath', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 9 subjects were randomized and 7 completed.'}, {'type': 'PRIMARY', 'title': 'Alcohol Consumption (BAC): Self-administration Block 2, Minute 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pitolisant', 'description': 'Subjects received 12 days of Pitolisant before the alcohol self-administration trial.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 12 days of placebo before the alcohol self-administration trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.086', 'spread': '0.040', 'groupId': 'OG000'}, {'value': '0.075', 'spread': '0.046', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 minute', 'description': 'Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable.', 'unitOfMeasure': 'Grams of alcohol/210 Liters of breath', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 9 subjects were randomized and 7 completed.'}, {'type': 'PRIMARY', 'title': 'Alcohol Consumption (BAC): Self-administration Block 2, Minute 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pitolisant', 'description': 'Subjects received 12 days of Pitolisant before the alcohol self-administration trial.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 12 days of placebo before the alcohol self-administration trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.079', 'spread': '0.047', 'groupId': 'OG000'}, {'value': '0.082', 'spread': '0.056', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 minute', 'description': 'Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable.', 'unitOfMeasure': 'Grams of alcohol/210 Liters of breath', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 9 subjects were randomized and 7 completed.'}, {'type': 'SECONDARY', 'title': 'Alcohol Craving During 12-day Drug Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pitolisant', 'description': 'Subjects received 12 days of Pitolisant before the alcohol self-administration trial.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 12 days of placebo before the alcohol self-administration trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '53.2', 'spread': '30.1', 'groupId': 'OG000'}, {'value': '47.2', 'spread': '33.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 days', 'description': 'The Visual Analog Scale (VAS) will be used to assess alcohol craving during the medication exposure period. The VAS is a 10 cm straight line with one end meaning no alcohol craving and the other end meaning intense alcohol craving. Higher VAS scores are associated with more cravings. Lower VAS scores are favorable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 9 subjects were randomized and 7 completed.'}, {'type': 'SECONDARY', 'title': 'Alcohol Consumption During the 12-day Drug Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pitolisant', 'description': 'Subjects received 12 days of Pitolisant before the alcohol self-administration trial.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 12 days of placebo before the alcohol self-administration trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '67.2', 'spread': '25.8', 'groupId': 'OG000'}, {'value': '66.8', 'spread': '15.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 days', 'description': 'Alcohol consumption during the 12 days of drug exposure will be measured using the timeline followback method. Lower (Standard Drink Units) SDUs are favorable.', 'unitOfMeasure': 'SDUs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '19 subjects were consented but 10 dropped out prior to randomization in the study (ineligible after screening or lost to follow-up). A total of 9 subjects were randomized and 7 completed.'}, {'type': 'SECONDARY', 'title': 'Alcohol-induced Stimulation: Observation Period, Minute 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pitolisant', 'description': 'Subjects received 12 days of Pitolisant before the alcohol self-administration trial.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 12 days of placebo before the alcohol self-administration trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.714', 'spread': '20.878', 'groupId': 'OG000'}, {'value': '30.714', 'spread': '12.433', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 minute', 'description': 'Whether pitolisant increases the stimulant effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher BAES scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on stimulation. Lower BAES scores are favorable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 9 subjects were randomized and 7 completed.'}, {'type': 'SECONDARY', 'title': 'Alcohol-induced Stimulation: Observation Period, Minute 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pitolisant', 'description': 'Subjects received 12 days of Pitolisant before the alcohol self-administration trial.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 12 days of placebo before the alcohol self-administration trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.429', 'spread': '19.957', 'groupId': 'OG000'}, {'value': '30.714', 'spread': '12.433', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 minute', 'description': 'Whether pitolisant increases the stimulant effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on stimulation. Lower BAES scores are favorable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 9 subjects were randomized and 7 completed.'}, {'type': 'SECONDARY', 'title': 'Alcohol-induced Stimulation: Observation Period, Minute 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pitolisant', 'description': 'Subjects received 12 days of Pitolisant before the alcohol self-administration trial.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 12 days of placebo before the alcohol self-administration trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.571', 'spread': '18.183', 'groupId': 'OG000'}, {'value': '31.857', 'spread': '13.322', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 minute', 'description': 'Whether pitolisant increases the stimulant effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on stimulation. Lower BAES scores are favorable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 9 subjects were randomized and 7 completed.'}, {'type': 'SECONDARY', 'title': 'Alcohol-induced Stimulation: Observation Period, Minute 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pitolisant', 'description': 'Subjects received 12 days of Pitolisant before the alcohol self-administration trial.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 12 days of placebo before the alcohol self-administration trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.714', 'spread': '17.557', 'groupId': 'OG000'}, {'value': '31.000', 'spread': '14.944', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 minute', 'description': 'Whether pitolisant increases the stimulant effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on stimulation. Lower BAES scores are favorable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 9 subjects were randomized and 7 completed.'}, {'type': 'SECONDARY', 'title': 'Alcohol-induced Stimulation: Self-Administration Block 1, Minute 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pitolisant', 'description': 'Subjects received 12 days of Pitolisant before the alcohol self-administration trial.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 12 days of placebo before the alcohol self-administration trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.143', 'spread': '19.463', 'groupId': 'OG000'}, {'value': '32.000', 'spread': '11.719', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 minute', 'description': 'Whether pitolisant increases the stimulant effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on stimulation. Lower BAES scores are favorable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 9 subjects were randomized and 7 completed.'}, {'type': 'SECONDARY', 'title': 'Alcohol-induced Stimulation: Self-Administration Block 1, Minute 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pitolisant', 'description': 'Subjects received 12 days of Pitolisant before the alcohol self-administration trial.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 12 days of placebo before the alcohol self-administration trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.571', 'spread': '18.831', 'groupId': 'OG000'}, {'value': '34.429', 'spread': '14.954', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 minute', 'description': 'Whether pitolisant increases the stimulant effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on stimulation. Lower BAES scores are favorable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 9 subjects were randomized and 7 completed.'}, {'type': 'SECONDARY', 'title': 'Alcohol-induced Stimulation: Self-Administration Block 2, Minute 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pitolisant', 'description': 'Subjects received 12 days of Pitolisant before the alcohol self-administration trial.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 12 days of placebo before the alcohol self-administration trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.286', 'spread': '17.792', 'groupId': 'OG000'}, {'value': '33.714', 'spread': '15.348', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 minute', 'description': 'Whether pitolisant increases the stimulant effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on stimulation. Lower BAES scores are favorable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 9 subjects were randomized and 7 completed.'}, {'type': 'SECONDARY', 'title': 'Alcohol-induced Stimulation: Self-Administration Block 2, Minute 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pitolisant', 'description': 'Subjects received 12 days of Pitolisant before the alcohol self-administration trial.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 12 days of placebo before the alcohol self-administration trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.714', 'spread': '16.680', 'groupId': 'OG000'}, {'value': '32.714', 'spread': '16.007', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 minute', 'description': 'Whether pitolisant increases the stimulant effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on stimulation. Lower BAES scores are favorable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 9 subjects were randomized and 7 completed.'}, {'type': 'SECONDARY', 'title': 'Alcohol-induced Sedation: Observation Period, Minute 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pitolisant', 'description': 'Subjects received 12 days of Pitolisant before the alcohol self-administration trial.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 12 days of placebo before the alcohol self-administration trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.714', 'spread': '8.920', 'groupId': 'OG000'}, {'value': '18.857', 'spread': '15.742', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 minute', 'description': 'Whether pitolisant increases the sedative effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on sedation. Lower BAES scores are favorable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 9 subjects were randomized and 7 completed.'}, {'type': 'SECONDARY', 'title': 'Alcohol-induced Sedation: Observation Period, Minute 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pitolisant', 'description': 'Subjects received 12 days of Pitolisant before the alcohol self-administration trial.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 12 days of placebo before the alcohol self-administration trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.429', 'spread': '5.827', 'groupId': 'OG000'}, {'value': '18.286', 'spread': '14.407', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 minute', 'description': 'Whether pitolisant increases the sedative effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on sedation. Lower BAES scores are favorable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 9 subjects were randomized and 7 completed.'}, {'type': 'SECONDARY', 'title': 'Alcohol-induced Sedation: Observation Period, Minute 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pitolisant', 'description': 'Subjects received 12 days of Pitolisant before the alcohol self-administration trial.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 12 days of placebo before the alcohol self-administration trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.286', 'spread': '5.407', 'groupId': 'OG000'}, {'value': '18.286', 'spread': '17.114', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 minute', 'description': 'Whether pitolisant increases the sedative effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on sedation. Lower BAES scores are favorable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 9 subjects were randomized and 7 completed.'}, {'type': 'SECONDARY', 'title': 'Alcohol-induced Sedation: Observation Period, Minute 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pitolisant', 'description': 'Subjects received 12 days of Pitolisant before the alcohol self-administration trial.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 12 days of placebo before the alcohol self-administration trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.571', 'spread': '7.300', 'groupId': 'OG000'}, {'value': '18.286', 'spread': '17.026', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 minute', 'description': 'Whether pitolisant increases the sedative effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on sedation. Lower BAES scores are favorable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 9 subjects were randomized and 7 completed.'}, {'type': 'SECONDARY', 'title': 'Alcohol-induced Sedation: Self-Administration Block 1, Minute 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pitolisant', 'description': 'Subjects received 12 days of Pitolisant before the alcohol self-administration trial.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 12 days of Placebo before the alcohol self-administration trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.714', 'spread': '7.041', 'groupId': 'OG000'}, {'value': '20.714', 'spread': '18.848', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 minute', 'description': 'Whether pitolisant increases the sedative effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on sedation. Lower BAES scores are favorable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 9 subjects were randomized and 7 completed.'}, {'type': 'SECONDARY', 'title': 'Alcohol-induced Sedation: Self-administration Block 1, Minute 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pitolisant', 'description': 'Subjects received 12 days of Pitolisant before the alcohol self-administration trial.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 12 days of placebo before the alcohol self-administration trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.286', 'spread': '8.440', 'groupId': 'OG000'}, {'value': '18.143', 'spread': '18.614', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 minute', 'description': 'Whether pitolisant increases the sedative effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on sedation. Lower BAES scores are favorable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 9 subjects were randomized and 7 completed.'}, {'type': 'SECONDARY', 'title': 'Alcohol-induced Sedation: Self-administration Block 2, Minute 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pitolisant', 'description': 'Subjects received 12 days of Pitolisant before the alcohol self-administration trial.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 12 days of placebo before the alcohol self-administration trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.286', 'spread': '10.323', 'groupId': 'OG000'}, {'value': '17.571', 'spread': '18.537', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 minute', 'description': 'Whether pitolisant increases the sedative effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on sedation. Lower BAES scores are favorable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 9 subjects were randomized and 7 completed.'}, {'type': 'SECONDARY', 'title': 'Alcohol-induced Sedation: Self-administration Block 2, Minute 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pitolisant', 'description': 'Subjects received 12 days of Pitolisant before the alcohol self-administration trial.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 12 days of placebo before the alcohol self-administration trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.571', 'spread': '14.316', 'groupId': 'OG000'}, {'value': '16.286', 'spread': '19.914', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 minute', 'description': 'Whether pitolisant increases the sedative effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on sedation. Lower BAES scores are favorable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 9 subjects were randomized and 7 completed.'}, {'type': 'SECONDARY', 'title': 'Alcohol Urge: Self-administration Block 1, Minute 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pitolisant', 'description': 'Subjects received 12 days of Pitolisant before the alcohol self-administration trial.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 12 days of placebo before the alcohol self-administration trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.57', 'spread': '10.937', 'groupId': 'OG000'}, {'value': '24.00', 'spread': '3.964', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 minute', 'description': "The Alcohol Urge questionnaire (AUQ) is an 8 item measure of self-reported urges to drink in human laboratory studies that assesses the participant's urge for an alcoholic drink at the time the questionnaire is completed, Questions are in the form of a 7-point Likert scale (from strongly disagree to strongly agree) and participants select the extent to which they disagree or agree with the 8 statements relating to desire to drink, expectation of a desired outcome from drinking, and inability to avoid drinking if alcohol was available. The minimum AUQ score is 8 and the maximum score is 56. Lower AUQ scores are associated with less urge for an alcoholic drink, and therefore more favorable.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 9 subjects were randomized and 7 completed.'}, {'type': 'SECONDARY', 'title': 'Alcohol Urge: Self-administration Block 1, Minute 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pitolisant', 'description': 'Subjects received 12 days of Pitolisant before the alcohol self-administration trial.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 12 days of placebo before the alcohol self-administration trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.43', 'spread': '11.674', 'groupId': 'OG000'}, {'value': '27.14', 'spread': '11.466', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 minute', 'description': "The Alcohol Urge questionnaire (AUQ) is an 8 item measure of self-reported urges to drink in human laboratory studies that assesses the participant's urge for an alcoholic drink at the time the questionnaire is completed, Questions are in the form of a 7-point Likert scale (from strongly disagree to strongly agree) and participants select the extent to which they disagree or agree with the 8 statements relating to desire to drink, expectation of a desired outcome from drinking, and inability to avoid drinking if alcohol was available. The minimum AUQ score is 8 and the maximum score is 56. Lower AUQ scores are associated with less urge for an alcoholic drink, and therefore more favorable.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 9 subjects were randomized and 7 completed.'}, {'type': 'SECONDARY', 'title': 'Alcohol Urge: Self-administration Block 2, Minute 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pitolisant', 'description': 'Subjects received 12 days of Pitolisant before the alcohol self-administration trial.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 12 days of placebo before the alcohol self-administration trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.29', 'spread': '13.048', 'groupId': 'OG000'}, {'value': '23.29', 'spread': '12.079', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 minute', 'description': "The Alcohol Urge questionnaire (AUQ) is an 8 item measure of self-reported urges to drink in human laboratory studies that assesses the participant's urge for an alcoholic drink at the time the questionnaire is completed, Questions are in the form of a 7-point Likert scale (from strongly disagree to strongly agree) and participants select the extent to which they disagree or agree with the 8 statements relating to desire to drink, expectation of a desired outcome from drinking, and inability to avoid drinking if alcohol was available. The minimum AUQ score is 8 and the maximum score is 56. Lower AUQ scores are associated with less urge for an alcoholic drink, and therefore more favorable.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 9 subjects were randomized and 7 completed.'}, {'type': 'SECONDARY', 'title': 'Alcohol Urge: Self-administration Block 2, Minute 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pitolisant', 'description': 'Subjects received 12 days of Pitolisant before the alcohol self-administration trial.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 12 days of placebo before the alcohol self-administration trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.00', 'spread': '12.055', 'groupId': 'OG000'}, {'value': '22.43', 'spread': '11.731', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 minute', 'description': "The Alcohol Urge questionnaire (AUQ) is an 8 item measure of self-reported urges to drink in human laboratory studies that assesses the participant's urge for an alcoholic drink at the time the questionnaire is completed, Questions are in the form of a 7-point Likert scale (from strongly disagree to strongly agree) and participants select the extent to which they disagree or agree with the 8 statements relating to desire to drink, expectation of a desired outcome from drinking, and inability to avoid drinking if alcohol was available. The minimum AUQ score is 8 and the maximum score is 56. Lower AUQ scores are associated with less urge for an alcoholic drink, and therefore more favorable.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 9 subjects were randomized and 7 completed.'}, {'type': 'SECONDARY', 'title': 'Alcohol Craving: Observation Period, Minute 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pitolisant', 'description': 'Subjects received 12 days of Pitolisant before the alcohol self-administration trial.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 12 days of placebo before the alcohol self-administration trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '44.57', 'spread': '22.970', 'groupId': 'OG000'}, {'value': '34.71', 'spread': '21.623', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 minute', 'description': 'Alcohol craving will be measured by self report with the Visual Analog Scale (VAS). The VAS is a straight line with one end meaning no alcohol craving (score of 0) and the other end meaning intense alcohol craving (score of 100). The Participant marks a point on the line that matches their amount of alcohol craving. Lower VAS score is favorable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 9 subjects were randomized and 7 completed.'}, {'type': 'SECONDARY', 'title': 'Alcohol Craving: Observation Period, Minute 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pitolisant', 'description': 'Subjects received 12 days of Pitolisant before the alcohol self-administration trial.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 12 days of placebo before the alcohol self-administration trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '44.43', 'spread': '31.405', 'groupId': 'OG000'}, {'value': '37.14', 'spread': '23.398', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 minute', 'description': 'Alcohol craving will be measured by self report with the Visual Analog Scale (VAS). The VAS is a straight line with one end meaning no alcohol craving (score of 0) and the other end meaning intense alcohol craving (score of 100). The Participant marks a point on the line that matches their amount of alcohol craving. Lower VAS score is favorable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 9 subjects were randomized and 7 completed.'}, {'type': 'SECONDARY', 'title': 'Alcohol Craving: Observation Period, Minute 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pitolisant', 'description': 'Subjects received 12 days of Pitolisant before the alcohol self-administration trial.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 12 days of placebo before the alcohol self-administration trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '47.29', 'spread': '26.266', 'groupId': 'OG000'}, {'value': '39.57', 'spread': '26.038', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 minute', 'description': 'Alcohol craving will be measured by self report with the Visual Analog Scale (VAS). The VAS is a straight line with one end meaning no alcohol craving (score of 0) and the other end meaning intense alcohol craving (score of 100). The Participant marks a point on the line that matches their amount of alcohol craving. Lower VAS score is favorable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 9 subjects were randomized and 7 completed.'}, {'type': 'SECONDARY', 'title': 'Alcohol Craving: Observation Period, Minute 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pitolisant', 'description': 'Subjects received 12 days of Pitolisant before the alcohol self-administration trial.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 12 days of pitolisant before the alcohol self-administration trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.57', 'spread': '29.051', 'groupId': 'OG000'}, {'value': '34.86', 'spread': '25.016', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 minute', 'description': 'Alcohol craving will be measured by self report with the Visual Analog Scale (VAS). The VAS is a straight line with one end meaning no alcohol craving (score of 0) and the other end meaning intense alcohol craving (score of 100). The Participant marks a point on the line that matches their amount of alcohol craving. Lower VAS score is favorable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 9 subjects were randomized and 7 completed.'}, {'type': 'SECONDARY', 'title': 'Alcohol Craving: Self-administration Block 1, Minute 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pitolisant', 'description': 'Subjects received 12 days of Pitolisant before the alcohol self-administration trial.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 12 days of placebo before the alcohol self-administration trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.29', 'spread': '24.965', 'groupId': 'OG000'}, {'value': '39.86', 'spread': '28.962', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 minute', 'description': 'Alcohol craving will be measured by self report with the Visual Analog Scale (VAS). The VAS is a straight line with one end meaning no alcohol craving (score of 0) and the other end meaning intense alcohol craving (score of 100). The Participant marks a point on the line that matches their amount of alcohol craving. Lower VAS score is favorable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 9 subjects were randomized and 7 completed.'}, {'type': 'SECONDARY', 'title': 'Alcohol Craving: Self-administration Block 1, Minute 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pitolisant', 'description': 'Subjects received 12 days of Pitolisant before the alcohol self-administration trial.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 12 days of placebo before the alcohol self-administration trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.14', 'spread': '27.492', 'groupId': 'OG000'}, {'value': '40.86', 'spread': '31.519', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 minute', 'description': 'Alcohol craving will be measured by self report with the Visual Analog Scale (VAS). The VAS is a straight line with one end meaning no alcohol craving (score of 0) and the other end meaning intense alcohol craving (score of 100). The Participant marks a point on the line that matches their amount of alcohol craving. Lower VAS score is favorable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 9 subjects were randomized and 7 completed.'}, {'type': 'SECONDARY', 'title': 'Alcohol Craving: Self-administration Block 2, Minute 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pitolisant', 'description': 'Subjects received 12 days of Pitolisant before the alcohol self-administration trial.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 12 days of placebo before the alcohol self-administration trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.00', 'spread': '33.650', 'groupId': 'OG000'}, {'value': '45.57', 'spread': '31.133', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 minute', 'description': 'Alcohol craving will be measured by self report with the Visual Analog Scale (VAS). The VAS is a straight line with one end meaning no alcohol craving (score of 0) and the other end meaning intense alcohol craving (score of 100). The Participant marks a point on the line that matches their amount of alcohol craving. Lower VAS score is favorable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 9 subjects were randomized and 7 completed.'}, {'type': 'SECONDARY', 'title': 'Alcohol Craving: Self-administration Block 2, Minute 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pitolisant', 'description': 'Subjects received 12 days of Pitolisant before the alcohol self-administration trial.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received 12 days of placebo before the alcohol self-administration trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.14', 'spread': '35.315', 'groupId': 'OG000'}, {'value': '42.43', 'spread': '29.860', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 minute', 'description': 'Alcohol craving will be measured by self report with the Visual Analog Scale (VAS). The VAS is a straight line with one end meaning no alcohol craving (score of 0) and the other end meaning intense alcohol craving (score of 100). The Participant marks a point on the line that matches their amount of alcohol craving. Lower VAS score is favorable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 9 subjects were randomized and 7 completed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pitolisant Then Placebo', 'description': 'This is a within subjects design study in which each subject receives both study drug and placebo. Subjects in this group received a dose of 8.9 mg (two 4.45 mg pills) of pitolisant once daily over a 7-day period and a dose of 17.8 mg (one 17.8 mg pill) of pitolisant once daily over a 5-day period before the first alcohol self-administration trial and 12 days of matched placebo before the second alcohol self-administration trial.'}, {'id': 'FG001', 'title': 'Placebo Then Pitolisant', 'description': 'This is a within subjects design study in which each subject receives both study drug and placebo. Subjects in this group received 12 days of matched placebo before the first alcohol self-administration trial and a dose of 8.9 mg (two 4.45 mg pills) of pitolisant once daily over a 7-day period and a dose of 17.8 mg (one 17.8 mg pill) of pitolisant once daily over a 5-day period before the second alcohol self-administration trial.'}], 'periods': [{'title': 'Medication Dispense/Exposure Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Alcohol Self-Administration Trial 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Medication Dispense/Exposure Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Alcohol Self-Administration Trial 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A.total of 9 subjects were enrolled and 7 completed the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pitolisant Then Placebo', 'description': 'This is a within subjects design study in which each subject receives both study drug and placebo. Subjects in this group received a dose of 8.9 mg (two 4.45 mg pills) of pitolisant once daily over a 7-day period and a dose of 17.8 mg (one 17.8 mg pill) of pitolisant once daily over a 5-day period before the first alcohol self-administration trial and 12 days of matched placebo before the second alcohol self-administration trial.'}, {'id': 'BG001', 'title': 'Placebo Then Pitolisant', 'description': 'This is a within subjects design study in which each subject receives both study drug and placebo. Subjects in this group received 12 days of matched placebo before the first alcohol self-administration trial and a dose of 8.9 mg (two 4.45 mg pills) of pitolisant once daily over a 7-day period and a dose of 17.8 mg (one 17.8 mg pill) of pitolisant once daily over a 5-day period before the second alcohol self-administration trial.'}, {'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': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', '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': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28', 'spread': '6', 'groupId': 'BG000'}, {'value': '33', 'spread': '7.9', 'groupId': 'BG001'}, {'value': '30.9', 'spread': '7.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-07-07', 'size': 1124047, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-08-16T14:54', 'hasProtocol': True}, {'date': '2022-10-26', 'size': 384338, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-05-17T16:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'This study is double-blind. Medications are over-encapsulated.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This is a double-blind, randomized, placebo-controlled, crossover design trial that will test the effect of pitolisant on alcohol self-administration and craving following a priming dose of alcohol.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'whyStopped': 'Study funding was exhausted prior to reaching the recruitment goal due to pandemic related delays', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-02-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-09', 'studyFirstSubmitDate': '2020-10-15', 'resultsFirstSubmitDate': '2023-10-12', 'studyFirstSubmitQcDate': '2020-10-15', 'lastUpdatePostDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-11-09', 'studyFirstPostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alcohol Consumption in Alcohol Self-Administration Trials', 'timeFrame': '2.6 hours', 'description': 'Alcohol consumption will be measured by using a graduated cylinder to determine the amount of alcohol given to the subject that was not consumed. This outcome will be measured as standard drink units (SDU). A standard drink contains approximately 0.6 fluid ounces of pure alcohol. Lower SDUs are favorable.'}, {'measure': 'Alcohol Consumption (BAC): Observation Period, Minute 10', 'timeFrame': '1 minute', 'description': 'Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable'}, {'measure': 'Alcohol Consumption (BAC): Observation Period, Minute 20', 'timeFrame': '1 minute', 'description': 'Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable.'}, {'measure': 'Alcohol Consumption (BAC): Observation Period, Minute 30', 'timeFrame': '1 minute', 'description': 'Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable.'}, {'measure': 'Alcohol Consumption (BAC): Observation Period, Minute 40', 'timeFrame': '1 minute', 'description': 'Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable.'}, {'measure': 'Alcohol Consumption (BAC): Self-administration Block 1, Minute 30', 'timeFrame': '1 minute', 'description': 'Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable.'}, {'measure': 'Alcohol Consumption (BAC): Self-administration Block 1, Minute 60', 'timeFrame': '1 minute', 'description': 'Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable.'}, {'measure': 'Alcohol Consumption (BAC): Self-administration Block 2, Minute 30', 'timeFrame': '1 minute', 'description': 'Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable.'}, {'measure': 'Alcohol Consumption (BAC): Self-administration Block 2, Minute 60', 'timeFrame': '1 minute', 'description': 'Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable.'}], 'secondaryOutcomes': [{'measure': 'Alcohol Craving During 12-day Drug Exposure', 'timeFrame': '12 days', 'description': 'The Visual Analog Scale (VAS) will be used to assess alcohol craving during the medication exposure period. The VAS is a 10 cm straight line with one end meaning no alcohol craving and the other end meaning intense alcohol craving. Higher VAS scores are associated with more cravings. Lower VAS scores are favorable.'}, {'measure': 'Alcohol Consumption During the 12-day Drug Exposure', 'timeFrame': '12 days', 'description': 'Alcohol consumption during the 12 days of drug exposure will be measured using the timeline followback method. Lower (Standard Drink Units) SDUs are favorable.'}, {'measure': 'Alcohol-induced Stimulation: Observation Period, Minute 10', 'timeFrame': '1 minute', 'description': 'Whether pitolisant increases the stimulant effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher BAES scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on stimulation. Lower BAES scores are favorable.'}, {'measure': 'Alcohol-induced Stimulation: Observation Period, Minute 20', 'timeFrame': '1 minute', 'description': 'Whether pitolisant increases the stimulant effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on stimulation. Lower BAES scores are favorable.'}, {'measure': 'Alcohol-induced Stimulation: Observation Period, Minute 30', 'timeFrame': '1 minute', 'description': 'Whether pitolisant increases the stimulant effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on stimulation. Lower BAES scores are favorable.'}, {'measure': 'Alcohol-induced Stimulation: Observation Period, Minute 40', 'timeFrame': '1 minute', 'description': 'Whether pitolisant increases the stimulant effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on stimulation. Lower BAES scores are favorable.'}, {'measure': 'Alcohol-induced Stimulation: Self-Administration Block 1, Minute 30', 'timeFrame': '1 minute', 'description': 'Whether pitolisant increases the stimulant effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on stimulation. Lower BAES scores are favorable.'}, {'measure': 'Alcohol-induced Stimulation: Self-Administration Block 1, Minute 60', 'timeFrame': '1 minute', 'description': 'Whether pitolisant increases the stimulant effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on stimulation. Lower BAES scores are favorable.'}, {'measure': 'Alcohol-induced Stimulation: Self-Administration Block 2, Minute 30', 'timeFrame': '1 minute', 'description': 'Whether pitolisant increases the stimulant effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on stimulation. Lower BAES scores are favorable.'}, {'measure': 'Alcohol-induced Stimulation: Self-Administration Block 2, Minute 60', 'timeFrame': '1 minute', 'description': 'Whether pitolisant increases the stimulant effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on stimulation. Lower BAES scores are favorable.'}, {'measure': 'Alcohol-induced Sedation: Observation Period, Minute 10', 'timeFrame': '1 minute', 'description': 'Whether pitolisant increases the sedative effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on sedation. Lower BAES scores are favorable.'}, {'measure': 'Alcohol-induced Sedation: Observation Period, Minute 20', 'timeFrame': '1 minute', 'description': 'Whether pitolisant increases the sedative effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on sedation. Lower BAES scores are favorable.'}, {'measure': 'Alcohol-induced Sedation: Observation Period, Minute 30', 'timeFrame': '1 minute', 'description': 'Whether pitolisant increases the sedative effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on sedation. Lower BAES scores are favorable.'}, {'measure': 'Alcohol-induced Sedation: Observation Period, Minute 40', 'timeFrame': '1 minute', 'description': 'Whether pitolisant increases the sedative effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on sedation. Lower BAES scores are favorable.'}, {'measure': 'Alcohol-induced Sedation: Self-Administration Block 1, Minute 30', 'timeFrame': '1 minute', 'description': 'Whether pitolisant increases the sedative effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on sedation. Lower BAES scores are favorable.'}, {'measure': 'Alcohol-induced Sedation: Self-administration Block 1, Minute 60', 'timeFrame': '1 minute', 'description': 'Whether pitolisant increases the sedative effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on sedation. Lower BAES scores are favorable.'}, {'measure': 'Alcohol-induced Sedation: Self-administration Block 2, Minute 30', 'timeFrame': '1 minute', 'description': 'Whether pitolisant increases the sedative effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on sedation. Lower BAES scores are favorable.'}, {'measure': 'Alcohol-induced Sedation: Self-administration Block 2, Minute 60', 'timeFrame': '1 minute', 'description': 'Whether pitolisant increases the sedative effects of a priming drink of alcohol will be assessed using the Biphasic Alcohol Effects Scale (BAES). It is a self-report, unipolar adjective rating scale that is designed to measure both stimulant and sedative effects of alcohol. It consists of fourteen items, that comprise two subscales (stimulant and sedative). Items are rated on a eleven-point scale from 0 (not at all) to 10 (extremely). The stimulant subscale can range from 0 to 70 and the sedative scale can rage from 0 to 50. Higher scores are associated with more stimulant and sedative effects, respectively. This section focuses solely on sedation. Lower BAES scores are favorable.'}, {'measure': 'Alcohol Urge: Self-administration Block 1, Minute 30', 'timeFrame': '1 minute', 'description': "The Alcohol Urge questionnaire (AUQ) is an 8 item measure of self-reported urges to drink in human laboratory studies that assesses the participant's urge for an alcoholic drink at the time the questionnaire is completed, Questions are in the form of a 7-point Likert scale (from strongly disagree to strongly agree) and participants select the extent to which they disagree or agree with the 8 statements relating to desire to drink, expectation of a desired outcome from drinking, and inability to avoid drinking if alcohol was available. The minimum AUQ score is 8 and the maximum score is 56. Lower AUQ scores are associated with less urge for an alcoholic drink, and therefore more favorable."}, {'measure': 'Alcohol Urge: Self-administration Block 1, Minute 60', 'timeFrame': '1 minute', 'description': "The Alcohol Urge questionnaire (AUQ) is an 8 item measure of self-reported urges to drink in human laboratory studies that assesses the participant's urge for an alcoholic drink at the time the questionnaire is completed, Questions are in the form of a 7-point Likert scale (from strongly disagree to strongly agree) and participants select the extent to which they disagree or agree with the 8 statements relating to desire to drink, expectation of a desired outcome from drinking, and inability to avoid drinking if alcohol was available. The minimum AUQ score is 8 and the maximum score is 56. Lower AUQ scores are associated with less urge for an alcoholic drink, and therefore more favorable."}, {'measure': 'Alcohol Urge: Self-administration Block 2, Minute 30', 'timeFrame': '1 minute', 'description': "The Alcohol Urge questionnaire (AUQ) is an 8 item measure of self-reported urges to drink in human laboratory studies that assesses the participant's urge for an alcoholic drink at the time the questionnaire is completed, Questions are in the form of a 7-point Likert scale (from strongly disagree to strongly agree) and participants select the extent to which they disagree or agree with the 8 statements relating to desire to drink, expectation of a desired outcome from drinking, and inability to avoid drinking if alcohol was available. The minimum AUQ score is 8 and the maximum score is 56. Lower AUQ scores are associated with less urge for an alcoholic drink, and therefore more favorable."}, {'measure': 'Alcohol Urge: Self-administration Block 2, Minute 60', 'timeFrame': '1 minute', 'description': "The Alcohol Urge questionnaire (AUQ) is an 8 item measure of self-reported urges to drink in human laboratory studies that assesses the participant's urge for an alcoholic drink at the time the questionnaire is completed, Questions are in the form of a 7-point Likert scale (from strongly disagree to strongly agree) and participants select the extent to which they disagree or agree with the 8 statements relating to desire to drink, expectation of a desired outcome from drinking, and inability to avoid drinking if alcohol was available. The minimum AUQ score is 8 and the maximum score is 56. Lower AUQ scores are associated with less urge for an alcoholic drink, and therefore more favorable."}, {'measure': 'Alcohol Craving: Observation Period, Minute 10', 'timeFrame': '1 minute', 'description': 'Alcohol craving will be measured by self report with the Visual Analog Scale (VAS). The VAS is a straight line with one end meaning no alcohol craving (score of 0) and the other end meaning intense alcohol craving (score of 100). The Participant marks a point on the line that matches their amount of alcohol craving. Lower VAS score is favorable.'}, {'measure': 'Alcohol Craving: Observation Period, Minute 20', 'timeFrame': '1 minute', 'description': 'Alcohol craving will be measured by self report with the Visual Analog Scale (VAS). The VAS is a straight line with one end meaning no alcohol craving (score of 0) and the other end meaning intense alcohol craving (score of 100). The Participant marks a point on the line that matches their amount of alcohol craving. Lower VAS score is favorable.'}, {'measure': 'Alcohol Craving: Observation Period, Minute 30', 'timeFrame': '1 minute', 'description': 'Alcohol craving will be measured by self report with the Visual Analog Scale (VAS). The VAS is a straight line with one end meaning no alcohol craving (score of 0) and the other end meaning intense alcohol craving (score of 100). The Participant marks a point on the line that matches their amount of alcohol craving. Lower VAS score is favorable.'}, {'measure': 'Alcohol Craving: Observation Period, Minute 40', 'timeFrame': '1 minute', 'description': 'Alcohol craving will be measured by self report with the Visual Analog Scale (VAS). The VAS is a straight line with one end meaning no alcohol craving (score of 0) and the other end meaning intense alcohol craving (score of 100). The Participant marks a point on the line that matches their amount of alcohol craving. Lower VAS score is favorable.'}, {'measure': 'Alcohol Craving: Self-administration Block 1, Minute 30', 'timeFrame': '1 minute', 'description': 'Alcohol craving will be measured by self report with the Visual Analog Scale (VAS). The VAS is a straight line with one end meaning no alcohol craving (score of 0) and the other end meaning intense alcohol craving (score of 100). The Participant marks a point on the line that matches their amount of alcohol craving. Lower VAS score is favorable.'}, {'measure': 'Alcohol Craving: Self-administration Block 1, Minute 60', 'timeFrame': '1 minute', 'description': 'Alcohol craving will be measured by self report with the Visual Analog Scale (VAS). The VAS is a straight line with one end meaning no alcohol craving (score of 0) and the other end meaning intense alcohol craving (score of 100). The Participant marks a point on the line that matches their amount of alcohol craving. Lower VAS score is favorable.'}, {'measure': 'Alcohol Craving: Self-administration Block 2, Minute 30', 'timeFrame': '1 minute', 'description': 'Alcohol craving will be measured by self report with the Visual Analog Scale (VAS). The VAS is a straight line with one end meaning no alcohol craving (score of 0) and the other end meaning intense alcohol craving (score of 100). The Participant marks a point on the line that matches their amount of alcohol craving. Lower VAS score is favorable.'}, {'measure': 'Alcohol Craving: Self-administration Block 2, Minute 60', 'timeFrame': '1 minute', 'description': 'Alcohol craving will be measured by self report with the Visual Analog Scale (VAS). The VAS is a straight line with one end meaning no alcohol craving (score of 0) and the other end meaning intense alcohol craving (score of 100). The Participant marks a point on the line that matches their amount of alcohol craving. Lower VAS score is favorable.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pitolisant', 'Wakix'], 'conditions': ['Alcohol Use Disorder', 'Alcohol Drinking']}, 'descriptionModule': {'briefSummary': 'This is a double-blind, randomized, placebo-controlled, crossover design trial that will test the effect of pitolisant on alcohol self-administration and craving following a priming dose of alcohol. The specific objective of this proposal is to determine whether pitolisant has effects on alcohol consumption and craving', 'detailedDescription': 'The present proposal is intended to answer the call for accelerating drug development by exploring the potential of a novel anticonvulsant, Pitolisant as a candidate medication for the treatment of AUD. Pitolisant is an H-3 receptor inverse agonist that is FDA-approved for treating narcolepsy which has been found to have effects of on alcohol craving and consumption in preclinical studies. The aims of this study are to test the effects of Pitolisant on alcohol self-administration and craving among a sample of non-treatment seeking heavy drinkers. The effects of 5-days of pitolisant (8.9mg) or placebo will be evaluated in a human laboratory using an alcohol self-administration methodology. In this within-subjects crossover design, heavy drinkers (N=28) will be randomized to the order of exposure (Pitolisant or placebo) prior to completing two alcohol self-administration trials. Subjects will receive a priming drink of alcohol and will have access to 8 alcoholic drinks over a 2-hour period. The investigators anticipate that subjects will consume less alcohol during an alcohol self-administration trial when receiving Pitolisant compared to when they are receiving placebo. Significant Pitolisant-induced reductions in the quantity of alcohol self-administered will be considered to be an indication that this drug may have value as an AUD medication. This study may provide a rationale for phase II clinical studies testing Pitolisant with a treatment-seeking AUD population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 21-55 years of age\n2. Able to verify age with a state or federal picture identification\n3. Exceeds safe weekly drinking limits during the 28 days prior to consent (average of 14 drinks for women or 21 drinks for men per week)\n4. Reports at least one episode of binge drinking (\\>3 drinks for women, \\>4 drinks for men) in the 28 days prior consent.\n5. Meets DSM-5 criteria for mild alcohol use disorder or greater severity.\n6. Has a smartphone to complete medication exposure period study assessments.\n\nExclusion Criteria:\n\n1. Seeking treatment for alcohol problems\n2. Clinical Institute Withdrawal Assessment at ≥10\n3. DSM-5 diagnosis of current major depression, bipolar disorder, schizophrenia, bulimia/anorexia, dementia, insomnia disorder or a substance use disorder other than alcohol, nicotine, marijuana or caffeine\n4. If female, pregnant, nursing, have plans to become pregnant\n5. If female, does not agree to use an accepted form of birth control\n6. Has a medical contraindication to the use of pitolisant\n7. Has medical or mental condition for which further alcohol exposure at the planned dose range would be contraindicated\n8. Current risk of suicidality (MINI suicidality score greater than 8 (low risk) or Yes to the ideation question #4 of the C-SSRS)\n9. BMI is greater than 40 or less than 18\n10. Impaired renal function (GFR \\<80 mL/min)\n11. Have a history of any clinically significant renal or hepatic disease\n12. Child-Pugh Score equal to or greater than Class B (evaluated based on presence or absence of encephalopathy and ascites, INR, bilirubin, and albumin) \\[https://www.mdcalc.com/child-pugh-score-cirrhosis-mortality\\]\n13. Have a clinically significant ECG as determined by the investigator or abnormal ECG heart rate (\\<45 or \\>100 bpm) or QTc interval corrected for heart rate using the Fridericia formula (QTcF) \\> 450 msec\n14. Have a history of cardiac arrhythmias or who for other reasons are at risk for developing Torsade de Pointes including those with bradycardia, hypokalemia, and congenital QT interval prolongation\n15. Has received alcohol counseling or other non-pharmacologic intervention to treat AUD in the past 90 days\n16. Has taken medications that are used to treat AUD in the past 90 days\n17. Has urine toxicology results positive for cocaine, opioids, amphetamines, buprenorphine, methadone, methamphetamines, oxycontin, barbiturates, or benzodiazepines.\n18. Subject is taking a medication which will significantly alter drug metabolism (e.g., strong CYP2D6 inhibitors, strong CYP3A4 inducers, or H1 receptor antagonists that cross the blood barrier (e.g. diphenhydramine or meclizine).\n19. Subject is known to be a poor CYP2D6 metabolizer.\n20. Subject is unable to comfortably abstain from nicotine for a period of 8 hours.\n21. Has Chronic Obstructive Pulmonary Disease (COPD), history of solid organ transplant, sickle cell disease, severe heart disease or other health condition for which exposure to COVID-19 represents an unreasonable risk as determined by the study staff physician using accepted COVID-19 guidance (e.g. Centers for Disease Control, etc.).'}, 'identificationModule': {'nctId': 'NCT04596267', 'briefTitle': 'Pitolisant Effects on Alcohol Self-Administration in Heavy Drinkers', 'organization': {'class': 'OTHER', 'fullName': 'Boston Medical Center'}, 'officialTitle': 'The Effects of the Histamine-3 Receptor Inverse Agonist Pitolisant on Alcohol Self-Administration in Heavy Drinkers', 'orgStudyIdInfo': {'id': 'H-40959'}, 'secondaryIdInfos': [{'id': '1R21AA028864-01', 'link': 'https://reporter.nih.gov/quickSearch/1R21AA028864-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pitolisant', 'description': 'Subjects will take an 8.9 mg dose (two 4.45 mg pills) of pitolisant once per day on day 1 through 4. On day 5, 8.9 mg will be taken in front of staff prior to an alcohol self administration trial.', 'interventionNames': ['Drug: Pitolisant']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subjects will take an placebo once per day on day 1 through 4. On day 5, a placebo will be taken in front of staff prior to an alcohol self administration trial.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Pitolisant', 'type': 'DRUG', 'otherNames': ['wakix'], 'description': '8.9mg Pitolisant for 5 days', 'armGroupLabels': ['Pitolisant']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Inert ingredients', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston University Psychiatry Research Center, Clinical Studies Unit', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Eric Devine, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Deidentified data from this study will be submitted to the NIAAA Data archive (https://nda.nih.gov/).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}