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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21AA028864-01 | U.S. NIH Grant/Contract | View source |
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Study funding was exhausted prior to reaching the recruitment goal due to pandemic related delays
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pitolisant | Experimental | 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. |
|
| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pitolisant | Drug | 8.9mg Pitolisant for 5 days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol Consumption in Alcohol Self-Administration Trials | 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. | 2.6 hours |
| Alcohol Consumption (BAC): Observation Period, Minute 10 | Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable | 1 minute |
| Alcohol Consumption (BAC): Observation Period, Minute 20 | Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable. | 1 minute |
| Alcohol Consumption (BAC): Observation Period, Minute 30 | Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable. | 1 minute |
| Alcohol Consumption (BAC): Observation Period, Minute 40 | Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable. | 1 minute |
| Alcohol Consumption (BAC): Self-administration Block 1, Minute 30 | Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable. |
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol Craving During 12-day Drug Exposure | 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. | 12 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Devine, PhD | Boston Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston University Psychiatry Research Center, Clinical Studies Unit | Boston | Massachusetts | 02118 | United States |
Deidentified data from this study will be submitted to the NIAAA Data archive (https://nda.nih.gov/).
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A.total of 9 subjects were enrolled and 7 completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pitolisant Then Placebo | 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. |
| FG001 | Placebo Then Pitolisant | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Medication Dispense/Exposure Period 1 |
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| Alcohol Self-Administration Trial 1 |
| ||||||||||||||||||||||
| Medication Dispense/Exposure Period 2 |
| ||||||||||||||||||||||
| Alcohol Self-Administration Trial 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pitolisant Then Placebo | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Alcohol Consumption in Alcohol Self-Administration Trials | 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. | A total of 9 subjects were randomized and 7 completed. | Posted | Mean | Standard Deviation | Total SDUs | 2.6 hours |
|
Up to 48 Days
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pitolisant | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bright yellow urine | Renal and urinary disorders | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eric Devine | Boston Medical Center | 617-418-7888 | eric.devine@bmc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 7, 2022 | Aug 16, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 26, 2022 | May 17, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C516975 | pitolisant |
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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.
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This study is double-blind. Medications are over-encapsulated.
| Placebo | Drug | Inert ingredients |
|
| 1 minute |
| Alcohol Consumption (BAC): Self-administration Block 1, Minute 60 | Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable. | 1 minute |
| Alcohol Consumption (BAC): Self-administration Block 2, Minute 30 | Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable. | 1 minute |
| Alcohol Consumption (BAC): Self-administration Block 2, Minute 60 | Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable. | 1 minute |
| Alcohol Consumption During the 12-day Drug Exposure | Alcohol consumption during the 12 days of drug exposure will be measured using the timeline followback method. Lower (Standard Drink Units) SDUs are favorable. | 12 days |
| Alcohol-induced Stimulation: Observation Period, Minute 10 | 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. | 1 minute |
| Alcohol-induced Stimulation: Observation Period, Minute 20 | 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. | 1 minute |
| Alcohol-induced Stimulation: Observation Period, Minute 30 | 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. | 1 minute |
| Alcohol-induced Stimulation: Observation Period, Minute 40 | 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. | 1 minute |
| Alcohol-induced Stimulation: Self-Administration Block 1, Minute 30 | 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. | 1 minute |
| Alcohol-induced Stimulation: Self-Administration Block 1, Minute 60 | 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. | 1 minute |
| Alcohol-induced Stimulation: Self-Administration Block 2, Minute 30 | 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. | 1 minute |
| Alcohol-induced Stimulation: Self-Administration Block 2, Minute 60 | 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. | 1 minute |
| Alcohol-induced Sedation: Observation Period, Minute 10 | 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. | 1 minute |
| Alcohol-induced Sedation: Observation Period, Minute 20 | 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. | 1 minute |
| Alcohol-induced Sedation: Observation Period, Minute 30 | 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. | 1 minute |
| Alcohol-induced Sedation: Observation Period, Minute 40 | 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. | 1 minute |
| Alcohol-induced Sedation: Self-Administration Block 1, Minute 30 | 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. | 1 minute |
| Alcohol-induced Sedation: Self-administration Block 1, Minute 60 | 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. | 1 minute |
| Alcohol-induced Sedation: Self-administration Block 2, Minute 30 | 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. | 1 minute |
| Alcohol-induced Sedation: Self-administration Block 2, Minute 60 | 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. | 1 minute |
| Alcohol Urge: Self-administration Block 1, Minute 30 | 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. | 1 minute |
| Alcohol Urge: Self-administration Block 1, Minute 60 | 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. | 1 minute |
| Alcohol Urge: Self-administration Block 2, Minute 30 | 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. | 1 minute |
| Alcohol Urge: Self-administration Block 2, Minute 60 | 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. | 1 minute |
| Alcohol Craving: Observation Period, Minute 10 | 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. | 1 minute |
| Alcohol Craving: Observation Period, Minute 20 | 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. | 1 minute |
| Alcohol Craving: Observation Period, Minute 30 | 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. | 1 minute |
| Alcohol Craving: Observation Period, Minute 40 | 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. | 1 minute |
| Alcohol Craving: Self-administration Block 1, Minute 30 | 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. | 1 minute |
| Alcohol Craving: Self-administration Block 1, Minute 60 | 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. | 1 minute |
| Alcohol Craving: Self-administration Block 2, Minute 30 | 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. | 1 minute |
| Alcohol Craving: Self-administration Block 2, Minute 60 | 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. | 1 minute |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | Placebo Then Pitolisant | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Alcohol Consumption (BAC): Observation Period, Minute 10 | Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable | A total of 9 subjects were randomized and 7 completed. | Posted | Mean | Standard Deviation | Grams of alcohol/210 Liters of breath | 1 minute |
|
|
|
| Primary | Alcohol Consumption (BAC): Observation Period, Minute 20 | Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable. | A total of 9 subjects were randomized and 7 completed. | Posted | Mean | Standard Deviation | Grams of alcohol/210 Liters of breath | 1 minute |
|
|
|
| Primary | Alcohol Consumption (BAC): Observation Period, Minute 30 | Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable. | A total of 9 subjects were randomized and 7 completed. | Posted | Mean | Standard Deviation | Grams of alcohol/210 Liters of breath | 1 minute |
|
|
|
| Primary | Alcohol Consumption (BAC): Observation Period, Minute 40 | Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable. | A total of 9 subjects were randomized and 7 completed. | Posted | Mean | Standard Deviation | Grams of alcohol/210 Liters of breath | 1 minute |
|
|
|
| Primary | Alcohol Consumption (BAC): Self-administration Block 1, Minute 30 | Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable. | A total of 9 subjects were randomized and 7 completed. | Posted | Mean | Standard Deviation | Grams of alcohol/210 Liters of breath | 1 minute |
|
|
|
| Primary | Alcohol Consumption (BAC): Self-administration Block 1, Minute 60 | Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable. | A total of 9 subjects were randomized and 7 completed. | Posted | Mean | Standard Deviation | Grams of alcohol/210 Liters of breath | 1 minute |
|
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| Primary | Alcohol Consumption (BAC): Self-administration Block 2, Minute 30 | Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable. | A total of 9 subjects were randomized and 7 completed. | Posted | Mean | Standard Deviation | Grams of alcohol/210 Liters of breath | 1 minute |
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| Primary | Alcohol Consumption (BAC): Self-administration Block 2, Minute 60 | Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable. | A total of 9 subjects were randomized and 7 completed. | Posted | Mean | Standard Deviation | Grams of alcohol/210 Liters of breath | 1 minute |
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| Secondary | Alcohol Craving During 12-day Drug Exposure | 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. | A total of 9 subjects were randomized and 7 completed. | Posted | Mean | Standard Deviation | score on a scale | 12 days |
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| Secondary | Alcohol Consumption During the 12-day Drug Exposure | Alcohol consumption during the 12 days of drug exposure will be measured using the timeline followback method. Lower (Standard Drink Units) SDUs are favorable. | 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. | Posted | Mean | Standard Deviation | SDUs | 12 days |
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| Secondary | Alcohol-induced Stimulation: Observation Period, Minute 10 | 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. | A total of 9 subjects were randomized and 7 completed. | Posted | Mean | Standard Deviation | score on a scale | 1 minute |
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| Secondary | Alcohol-induced Stimulation: Observation Period, Minute 20 | 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. | A total of 9 subjects were randomized and 7 completed. | Posted | Mean | Standard Deviation | score on a scale | 1 minute |
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| Secondary | Alcohol-induced Stimulation: Observation Period, Minute 30 | 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. | A total of 9 subjects were randomized and 7 completed. | Posted | Mean | Standard Deviation | score on a scale | 1 minute |
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| Secondary | Alcohol-induced Stimulation: Observation Period, Minute 40 | 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. | A total of 9 subjects were randomized and 7 completed. | Posted | Mean | Standard Deviation | score on a scale | 1 minute |
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| Secondary | Alcohol-induced Stimulation: Self-Administration Block 1, Minute 30 | 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. | A total of 9 subjects were randomized and 7 completed. | Posted | Mean | Standard Deviation | score on a scale | 1 minute |
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| Secondary | Alcohol-induced Stimulation: Self-Administration Block 1, Minute 60 | 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. | A total of 9 subjects were randomized and 7 completed. | Posted | Mean | Standard Deviation | score on a scale | 1 minute |
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| Secondary | Alcohol-induced Stimulation: Self-Administration Block 2, Minute 30 | 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. | A total of 9 subjects were randomized and 7 completed. | Posted | Mean | Standard Deviation | score on a scale | 1 minute |
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| Secondary | Alcohol-induced Stimulation: Self-Administration Block 2, Minute 60 | 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. | A total of 9 subjects were randomized and 7 completed. | Posted | Mean | Standard Deviation | score on a scale | 1 minute |
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| Secondary | Alcohol-induced Sedation: Observation Period, Minute 10 | 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. | A total of 9 subjects were randomized and 7 completed. | Posted | Mean | Standard Deviation | score on a scale | 1 minute |
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| Secondary | Alcohol-induced Sedation: Observation Period, Minute 20 | 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. | A total of 9 subjects were randomized and 7 completed. | Posted | Mean | Standard Deviation | score on a scale | 1 minute |
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| Secondary | Alcohol-induced Sedation: Observation Period, Minute 30 | 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. | A total of 9 subjects were randomized and 7 completed. | Posted | Mean | Standard Deviation | score on a scale | 1 minute |
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| Secondary | Alcohol-induced Sedation: Observation Period, Minute 40 | 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. | A total of 9 subjects were randomized and 7 completed. | Posted | Mean | Standard Deviation | score on a scale | 1 minute |
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| Secondary | Alcohol-induced Sedation: Self-Administration Block 1, Minute 30 | 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. | A total of 9 subjects were randomized and 7 completed. | Posted | Mean | Standard Deviation | score on a scale | 1 minute |
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| Secondary | Alcohol-induced Sedation: Self-administration Block 1, Minute 60 | 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. | A total of 9 subjects were randomized and 7 completed. | Posted | Mean | Standard Deviation | score on a scale | 1 minute |
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| Secondary | Alcohol-induced Sedation: Self-administration Block 2, Minute 30 | 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. | A total of 9 subjects were randomized and 7 completed. | Posted | Mean | Standard Deviation | score on a scale | 1 minute |
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| Secondary | Alcohol-induced Sedation: Self-administration Block 2, Minute 60 | 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. | A total of 9 subjects were randomized and 7 completed. | Posted | Mean | Standard Deviation | score on a scale | 1 minute |
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| Secondary | Alcohol Urge: Self-administration Block 1, Minute 30 | 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. | A total of 9 subjects were randomized and 7 completed. | Posted | Mean | Standard Deviation | score on a scale | 1 minute |
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| Secondary | Alcohol Urge: Self-administration Block 1, Minute 60 | 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. | A total of 9 subjects were randomized and 7 completed. | Posted | Mean | Standard Deviation | score on a scale | 1 minute |
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| Secondary | Alcohol Urge: Self-administration Block 2, Minute 30 | 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. | A total of 9 subjects were randomized and 7 completed. | Posted | Mean | Standard Deviation | score on a scale | 1 minute |
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| Secondary | Alcohol Urge: Self-administration Block 2, Minute 60 | 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. | A total of 9 subjects were randomized and 7 completed. | Posted | Mean | Standard Deviation | score on a scale | 1 minute |
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| Secondary | Alcohol Craving: Observation Period, Minute 10 | 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. | A total of 9 subjects were randomized and 7 completed. | Posted | Mean | Standard Deviation | score on a scale | 1 minute |
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| Secondary | Alcohol Craving: Observation Period, Minute 20 | 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. | A total of 9 subjects were randomized and 7 completed. | Posted | Mean | Standard Deviation | score on a scale | 1 minute |
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| Secondary | Alcohol Craving: Observation Period, Minute 30 | 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. | A total of 9 subjects were randomized and 7 completed. | Posted | Mean | Standard Deviation | score on a scale | 1 minute |
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| Secondary | Alcohol Craving: Observation Period, Minute 40 | 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. | A total of 9 subjects were randomized and 7 completed. | Posted | Mean | Standard Deviation | score on a scale | 1 minute |
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| Secondary | Alcohol Craving: Self-administration Block 1, Minute 30 | 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. | A total of 9 subjects were randomized and 7 completed. | Posted | Mean | Standard Deviation | score on a scale | 1 minute |
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| Secondary | Alcohol Craving: Self-administration Block 1, Minute 60 | 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. | A total of 9 subjects were randomized and 7 completed. | Posted | Mean | Standard Deviation | score on a scale | 1 minute |
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| Secondary | Alcohol Craving: Self-administration Block 2, Minute 30 | 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. | A total of 9 subjects were randomized and 7 completed. | Posted | Mean | Standard Deviation | score on a scale | 1 minute |
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| Secondary | Alcohol Craving: Self-administration Block 2, Minute 60 | 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. | A total of 9 subjects were randomized and 7 completed. | Posted | Mean | Standard Deviation | score on a scale | 1 minute |
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| 0 |
| 7 |
| 0 |
| 7 |
| 2 |
| 7 |
| EG001 | Placebo | 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. | 0 | 7 | 0 | 7 | 2 | 7 |
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Increased Thirst | General disorders | Systematic Assessment |
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| Left Ankle Pain | General disorders | Systematic Assessment | Due to sprained ankle |
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| Right knee contusion with abrasion | General disorders | Systematic Assessment |
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Not provided
Not provided
| D004327 | Drinking Behavior |
| D001519 | Behavior |