Alcohol Drinking, Alcohol Use Disorder
Conditions
Keywords
pitolisant, Wakix
Brief summary
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
Detailed description
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.
Interventions
DRUGPitolisant
8.9mg Pitolisant for 5 days
DRUGPlacebo
Inert ingredients
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Boston Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
This study is double-blind. Medications are over-encapsulated.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. 21-55 years of age 2. Able to verify age with a state or federal picture identification 3. 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) 4. Reports at least one episode of binge drinking (\>3 drinks for women, \>4 drinks for men) in the 28 days prior consent. 5. Meets DSM-5 criteria for mild alcohol use disorder or greater severity. 6. Has a smartphone to complete medication exposure period study assessments.
Exclusion criteria
1. Seeking treatment for alcohol problems 2. Clinical Institute Withdrawal Assessment at ≥10 3. 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 4. If female, pregnant, nursing, have plans to become pregnant 5. If female, does not agree to use an accepted form of birth control 6. Has a medical contraindication to the use of pitolisant 7. Has medical or mental condition for which further alcohol exposure at the planned dose range would be contraindicated 8. Current risk of suicidality (MINI suicidality score greater than 8 (low risk) or Yes to the ideation question #4 of the C-SSRS) 9. BMI is greater than 40 or less than 18 10. Impaired renal function (GFR \<80 mL/min) 11. Have a history of any clinically significant renal or hepatic disease 12. Child-Pugh Score equal to or greater than Class B (evaluated based on presence or absence of encephalopathy and ascites, INR, bilirubin, and albumin) \[https://www.mdcalc.com/child-pugh-score-cirrhosis-mortality\] 13. 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 14. 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 15. Has received alcohol counseling or other non-pharmacologic intervention to treat AUD in the past 90 days 16. Has taken medications that are used to treat AUD in the past 90 days 17. Has urine toxicology results positive for cocaine, opioids, amphetamines, buprenorphine, methadone, methamphetamines, oxycontin, barbiturates, or benzodiazepines. 18. 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). 19. Subject is known to be a poor CYP2D6 metabolizer. 20. Subject is unable to comfortably abstain from nicotine for a period of 8 hours. 21. 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.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol Consumption in Alcohol Self-Administration Trials | 2.6 hours | 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. |
| Alcohol Consumption (BAC): Observation Period, Minute 10 | 1 minute | Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable |
| Alcohol Consumption (BAC): Observation Period, Minute 20 | 1 minute | Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable. |
| Alcohol Consumption (BAC): Observation Period, Minute 30 | 1 minute | Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable. |
| Alcohol Consumption (BAC): Observation Period, Minute 40 | 1 minute | Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable. |
| Alcohol Consumption (BAC): Self-administration Block 1, Minute 30 | 1 minute | Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable. |
| Alcohol Consumption (BAC): Self-administration Block 1, Minute 60 | 1 minute | Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable. |
| Alcohol Consumption (BAC): Self-administration Block 2, Minute 30 | 1 minute | Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable. |
| Alcohol Consumption (BAC): Self-administration Block 2, Minute 60 | 1 minute | Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol-induced Stimulation: Self-Administration Block 2, Minute 60 | 1 minute | 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. |
| Alcohol-induced Sedation: Observation Period, Minute 10 | 1 minute | 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. |
| Alcohol-induced Sedation: Observation Period, Minute 20 | 1 minute | 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. |
| Alcohol-induced Sedation: Observation Period, Minute 30 | 1 minute | 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. |
| Alcohol-induced Sedation: Observation Period, Minute 40 | 1 minute | 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. |
| Alcohol-induced Sedation: Self-Administration Block 1, Minute 30 | 1 minute | 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. |
| Alcohol-induced Sedation: Self-administration Block 1, Minute 60 | 1 minute | 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. |
| Alcohol-induced Sedation: Self-administration Block 2, Minute 30 | 1 minute | 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. |
| Alcohol-induced Sedation: Self-administration Block 2, Minute 60 | 1 minute | 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. |
| Alcohol Urge: Self-administration Block 1, Minute 30 | 1 minute | 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. |
| Alcohol Craving During 12-day Drug Exposure | 12 days | 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. |
| Alcohol Urge: Self-administration Block 2, Minute 30 | 1 minute | 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. |
| Alcohol Urge: Self-administration Block 2, Minute 60 | 1 minute | 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. |
| Alcohol Craving: Observation Period, Minute 10 | 1 minute | 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. |
| Alcohol Craving: Observation Period, Minute 20 | 1 minute | 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. |
| Alcohol Craving: Observation Period, Minute 30 | 1 minute | 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. |
| Alcohol Craving: Observation Period, Minute 40 | 1 minute | 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. |
| Alcohol Craving: Self-administration Block 1, Minute 30 | 1 minute | 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. |
| Alcohol Craving: Self-administration Block 1, Minute 60 | 1 minute | 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. |
| Alcohol Craving: Self-administration Block 2, Minute 30 | 1 minute | 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. |
| Alcohol Craving: Self-administration Block 2, Minute 60 | 1 minute | 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. |
| Alcohol Urge: Self-administration Block 1, Minute 60 | 1 minute | 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. |
| Alcohol Consumption During the 12-day Drug Exposure | 12 days | Alcohol consumption during the 12 days of drug exposure will be measured using the timeline followback method. Lower (Standard Drink Units) SDUs are favorable. |
| Alcohol-induced Stimulation: Observation Period, Minute 10 | 1 minute | 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. |
| Alcohol-induced Stimulation: Observation Period, Minute 20 | 1 minute | 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. |
| Alcohol-induced Stimulation: Observation Period, Minute 30 | 1 minute | 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. |
| Alcohol-induced Stimulation: Observation Period, Minute 40 | 1 minute | 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. |
| Alcohol-induced Stimulation: Self-Administration Block 1, Minute 30 | 1 minute | 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. |
| Alcohol-induced Stimulation: Self-Administration Block 1, Minute 60 | 1 minute | 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. |
| Alcohol-induced Stimulation: Self-Administration Block 2, Minute 30 | 1 minute | 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. |
Countries
United States
Participant flow
Pre-assignment details
A.total of 9 subjects were enrolled and 7 completed the study.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 4 |
| 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. | 5 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Medication Dispense/Exposure Period 1 | Lost to Follow-up | 1 | 0 |
| Medication Dispense/Exposure Period 1 | Physician Decision | 0 | 1 |
Baseline characteristics
| Characteristic | Pitolisant Then Placebo | Placebo Then Pitolisant | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 5 Participants | 9 Participants |
| Age, Continuous | 28 years STANDARD_DEVIATION 6 | 33 years STANDARD_DEVIATION 7.9 | 30.9 years STANDARD_DEVIATION 7.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 5 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 4 Participants | 8 Participants |
| Region of Enrollment United States | 4 participants | 5 participants | 9 participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 7 |
| other Total, other adverse events | 2 / 7 | 2 / 7 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 |
Outcome results
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
Time frame: 1 minute
Population: A total of 9 subjects were randomized and 7 completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitolisant | Alcohol Consumption (BAC): Observation Period, Minute 10 | 0.034 Grams of alcohol/210 Liters of breath | Standard Deviation 0.005 |
| Placebo | Alcohol Consumption (BAC): Observation Period, Minute 10 | 0.033 Grams of alcohol/210 Liters of breath | Standard Deviation 0.01 |
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.
Time frame: 1 minute
Population: A total of 9 subjects were randomized and 7 completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitolisant | Alcohol Consumption (BAC): Observation Period, Minute 20 | 0.038 Grams of alcohol/210 Liters of breath | Standard Deviation 0.009 |
| Placebo | Alcohol Consumption (BAC): Observation Period, Minute 20 | 0.0364 Grams of alcohol/210 Liters of breath | Standard Deviation 0.011 |
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.
Time frame: 1 minute
Population: A total of 9 subjects were randomized and 7 completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitolisant | Alcohol Consumption (BAC): Observation Period, Minute 30 | 0.037 Grams of alcohol/210 Liters of breath | Standard Deviation 0.003 |
| Placebo | Alcohol Consumption (BAC): Observation Period, Minute 30 | 0.034 Grams of alcohol/210 Liters of breath | Standard Deviation 0.009 |
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.
Time frame: 1 minute
Population: A total of 9 subjects were randomized and 7 completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitolisant | Alcohol Consumption (BAC): Observation Period, Minute 40 | 0.033 Grams of alcohol/210 Liters of breath | Standard Deviation 0.006 |
| Placebo | Alcohol Consumption (BAC): Observation Period, Minute 40 | 0.031 Grams of alcohol/210 Liters of breath | Standard Deviation 0.006 |
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.
Time frame: 1 minute
Population: A total of 9 subjects were randomized and 7 completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitolisant | Alcohol Consumption (BAC): Self-administration Block 1, Minute 30 | 0.069 Grams of alcohol/210 Liters of breath | Standard Deviation 0.046 |
| Placebo | Alcohol Consumption (BAC): Self-administration Block 1, Minute 30 | 0.063 Grams of alcohol/210 Liters of breath | Standard Deviation 0.033 |
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.
Time frame: 1 minute
Population: A total of 9 subjects were randomized and 7 completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitolisant | Alcohol Consumption (BAC): Self-administration Block 1, Minute 60 | 0.072 Grams of alcohol/210 Liters of breath | Standard Deviation 0.037 |
| Placebo | Alcohol Consumption (BAC): Self-administration Block 1, Minute 60 | 0.047 Grams of alcohol/210 Liters of breath | Standard Deviation 0.021 |
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.
Time frame: 1 minute
Population: A total of 9 subjects were randomized and 7 completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitolisant | Alcohol Consumption (BAC): Self-administration Block 2, Minute 30 | 0.086 Grams of alcohol/210 Liters of breath | Standard Deviation 0.04 |
| Placebo | Alcohol Consumption (BAC): Self-administration Block 2, Minute 30 | 0.075 Grams of alcohol/210 Liters of breath | Standard Deviation 0.046 |
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.
Time frame: 1 minute
Population: A total of 9 subjects were randomized and 7 completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitolisant | Alcohol Consumption (BAC): Self-administration Block 2, Minute 60 | 0.079 Grams of alcohol/210 Liters of breath | Standard Deviation 0.047 |
| Placebo | Alcohol Consumption (BAC): Self-administration Block 2, Minute 60 | 0.082 Grams of alcohol/210 Liters of breath | Standard Deviation 0.056 |
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.
Time frame: 2.6 hours
Population: A total of 9 subjects were randomized and 7 completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitolisant | Alcohol Consumption in Alcohol Self-Administration Trials | 67.214 Total SDUs | Standard Deviation 25.759 |
| Placebo | Alcohol Consumption in Alcohol Self-Administration Trials | 66.786 Total SDUs | Standard Deviation 15.369 |
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.
Time frame: 12 days
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitolisant | Alcohol Consumption During the 12-day Drug Exposure | 67.2 SDUs | Standard Deviation 25.8 |
| Placebo | Alcohol Consumption During the 12-day Drug Exposure | 66.8 SDUs | Standard Deviation 15.4 |
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.
Time frame: 12 days
Population: A total of 9 subjects were randomized and 7 completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitolisant | Alcohol Craving During 12-day Drug Exposure | 53.2 score on a scale | Standard Deviation 30.1 |
| Placebo | Alcohol Craving During 12-day Drug Exposure | 47.2 score on a scale | Standard Deviation 33.7 |
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.
Time frame: 1 minute
Population: A total of 9 subjects were randomized and 7 completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitolisant | Alcohol Craving: Observation Period, Minute 10 | 44.57 score on a scale | Standard Deviation 22.97 |
| Placebo | Alcohol Craving: Observation Period, Minute 10 | 34.71 score on a scale | Standard Deviation 21.623 |
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.
Time frame: 1 minute
Population: A total of 9 subjects were randomized and 7 completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitolisant | Alcohol Craving: Observation Period, Minute 20 | 44.43 score on a scale | Standard Deviation 31.405 |
| Placebo | Alcohol Craving: Observation Period, Minute 20 | 37.14 score on a scale | Standard Deviation 23.398 |
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.
Time frame: 1 minute
Population: A total of 9 subjects were randomized and 7 completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitolisant | Alcohol Craving: Observation Period, Minute 30 | 47.29 score on a scale | Standard Deviation 26.266 |
| Placebo | Alcohol Craving: Observation Period, Minute 30 | 39.57 score on a scale | Standard Deviation 26.038 |
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.
Time frame: 1 minute
Population: A total of 9 subjects were randomized and 7 completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitolisant | Alcohol Craving: Observation Period, Minute 40 | 50.57 score on a scale | Standard Deviation 29.051 |
| Placebo | Alcohol Craving: Observation Period, Minute 40 | 34.86 score on a scale | Standard Deviation 25.016 |
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.
Time frame: 1 minute
Population: A total of 9 subjects were randomized and 7 completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitolisant | Alcohol Craving: Self-administration Block 1, Minute 30 | 41.29 score on a scale | Standard Deviation 24.965 |
| Placebo | Alcohol Craving: Self-administration Block 1, Minute 30 | 39.86 score on a scale | Standard Deviation 28.962 |
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.
Time frame: 1 minute
Population: A total of 9 subjects were randomized and 7 completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitolisant | Alcohol Craving: Self-administration Block 1, Minute 60 | 42.14 score on a scale | Standard Deviation 27.492 |
| Placebo | Alcohol Craving: Self-administration Block 1, Minute 60 | 40.86 score on a scale | Standard Deviation 31.519 |
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.
Time frame: 1 minute
Population: A total of 9 subjects were randomized and 7 completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitolisant | Alcohol Craving: Self-administration Block 2, Minute 30 | 35.00 score on a scale | Standard Deviation 33.65 |
| Placebo | Alcohol Craving: Self-administration Block 2, Minute 30 | 45.57 score on a scale | Standard Deviation 31.133 |
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.
Time frame: 1 minute
Population: A total of 9 subjects were randomized and 7 completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitolisant | Alcohol Craving: Self-administration Block 2, Minute 60 | 41.14 score on a scale | Standard Deviation 35.315 |
| Placebo | Alcohol Craving: Self-administration Block 2, Minute 60 | 42.43 score on a scale | Standard Deviation 29.86 |
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.
Time frame: 1 minute
Population: A total of 9 subjects were randomized and 7 completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitolisant | Alcohol-induced Sedation: Observation Period, Minute 10 | 12.714 score on a scale | Standard Deviation 8.92 |
| Placebo | Alcohol-induced Sedation: Observation Period, Minute 10 | 18.857 score on a scale | Standard Deviation 15.742 |
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.
Time frame: 1 minute
Population: A total of 9 subjects were randomized and 7 completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitolisant | Alcohol-induced Sedation: Observation Period, Minute 20 | 9.429 score on a scale | Standard Deviation 5.827 |
| Placebo | Alcohol-induced Sedation: Observation Period, Minute 20 | 18.286 score on a scale | Standard Deviation 14.407 |
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.
Time frame: 1 minute
Population: A total of 9 subjects were randomized and 7 completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitolisant | Alcohol-induced Sedation: Observation Period, Minute 30 | 7.286 score on a scale | Standard Deviation 5.407 |
| Placebo | Alcohol-induced Sedation: Observation Period, Minute 30 | 18.286 score on a scale | Standard Deviation 17.114 |
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.
Time frame: 1 minute
Population: A total of 9 subjects were randomized and 7 completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitolisant | Alcohol-induced Sedation: Observation Period, Minute 40 | 8.571 score on a scale | Standard Deviation 7.3 |
| Placebo | Alcohol-induced Sedation: Observation Period, Minute 40 | 18.286 score on a scale | Standard Deviation 17.026 |
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.
Time frame: 1 minute
Population: A total of 9 subjects were randomized and 7 completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitolisant | Alcohol-induced Sedation: Self-Administration Block 1, Minute 30 | 9.714 score on a scale | Standard Deviation 7.041 |
| Placebo | Alcohol-induced Sedation: Self-Administration Block 1, Minute 30 | 20.714 score on a scale | Standard Deviation 18.848 |
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.
Time frame: 1 minute
Population: A total of 9 subjects were randomized and 7 completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitolisant | Alcohol-induced Sedation: Self-administration Block 1, Minute 60 | 10.286 score on a scale | Standard Deviation 8.44 |
| Placebo | Alcohol-induced Sedation: Self-administration Block 1, Minute 60 | 18.143 score on a scale | Standard Deviation 18.614 |
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.
Time frame: 1 minute
Population: A total of 9 subjects were randomized and 7 completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitolisant | Alcohol-induced Sedation: Self-administration Block 2, Minute 30 | 11.286 score on a scale | Standard Deviation 10.323 |
| Placebo | Alcohol-induced Sedation: Self-administration Block 2, Minute 30 | 17.571 score on a scale | Standard Deviation 18.537 |
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.
Time frame: 1 minute
Population: A total of 9 subjects were randomized and 7 completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitolisant | Alcohol-induced Sedation: Self-administration Block 2, Minute 60 | 9.571 score on a scale | Standard Deviation 14.316 |
| Placebo | Alcohol-induced Sedation: Self-administration Block 2, Minute 60 | 16.286 score on a scale | Standard Deviation 19.914 |
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.
Time frame: 1 minute
Population: A total of 9 subjects were randomized and 7 completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitolisant | Alcohol-induced Stimulation: Observation Period, Minute 10 | 31.714 score on a scale | Standard Deviation 20.878 |
| Placebo | Alcohol-induced Stimulation: Observation Period, Minute 10 | 30.714 score on a scale | Standard Deviation 12.433 |
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.
Time frame: 1 minute
Population: A total of 9 subjects were randomized and 7 completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitolisant | Alcohol-induced Stimulation: Observation Period, Minute 20 | 31.429 score on a scale | Standard Deviation 19.957 |
| Placebo | Alcohol-induced Stimulation: Observation Period, Minute 20 | 30.714 score on a scale | Standard Deviation 12.433 |
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.
Time frame: 1 minute
Population: A total of 9 subjects were randomized and 7 completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitolisant | Alcohol-induced Stimulation: Observation Period, Minute 30 | 29.571 score on a scale | Standard Deviation 18.183 |
| Placebo | Alcohol-induced Stimulation: Observation Period, Minute 30 | 31.857 score on a scale | Standard Deviation 13.322 |
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.
Time frame: 1 minute
Population: A total of 9 subjects were randomized and 7 completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitolisant | Alcohol-induced Stimulation: Observation Period, Minute 40 | 29.714 score on a scale | Standard Deviation 17.557 |
| Placebo | Alcohol-induced Stimulation: Observation Period, Minute 40 | 31.000 score on a scale | Standard Deviation 14.944 |
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.
Time frame: 1 minute
Population: A total of 9 subjects were randomized and 7 completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitolisant | Alcohol-induced Stimulation: Self-Administration Block 1, Minute 30 | 32.143 score on a scale | Standard Deviation 19.463 |
| Placebo | Alcohol-induced Stimulation: Self-Administration Block 1, Minute 30 | 32.000 score on a scale | Standard Deviation 11.719 |
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.
Time frame: 1 minute
Population: A total of 9 subjects were randomized and 7 completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitolisant | Alcohol-induced Stimulation: Self-Administration Block 1, Minute 60 | 31.571 score on a scale | Standard Deviation 18.831 |
| Placebo | Alcohol-induced Stimulation: Self-Administration Block 1, Minute 60 | 34.429 score on a scale | Standard Deviation 14.954 |
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.
Time frame: 1 minute
Population: A total of 9 subjects were randomized and 7 completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitolisant | Alcohol-induced Stimulation: Self-Administration Block 2, Minute 30 | 31.286 score on a scale | Standard Deviation 17.792 |
| Placebo | Alcohol-induced Stimulation: Self-Administration Block 2, Minute 30 | 33.714 score on a scale | Standard Deviation 15.348 |
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.
Time frame: 1 minute
Population: A total of 9 subjects were randomized and 7 completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitolisant | Alcohol-induced Stimulation: Self-Administration Block 2, Minute 60 | 28.714 score on a scale | Standard Deviation 16.68 |
| Placebo | Alcohol-induced Stimulation: Self-Administration Block 2, Minute 60 | 32.714 score on a scale | Standard Deviation 16.007 |
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.
Time frame: 1 minute
Population: A total of 9 subjects were randomized and 7 completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitolisant | Alcohol Urge: Self-administration Block 1, Minute 30 | 26.57 score on a scale | Standard Deviation 10.937 |
| Placebo | Alcohol Urge: Self-administration Block 1, Minute 30 | 24.00 score on a scale | Standard Deviation 3.964 |
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.
Time frame: 1 minute
Population: A total of 9 subjects were randomized and 7 completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitolisant | Alcohol Urge: Self-administration Block 1, Minute 60 | 23.43 score on a scale | Standard Deviation 11.674 |
| Placebo | Alcohol Urge: Self-administration Block 1, Minute 60 | 27.14 score on a scale | Standard Deviation 11.466 |
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.
Time frame: 1 minute
Population: A total of 9 subjects were randomized and 7 completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitolisant | Alcohol Urge: Self-administration Block 2, Minute 30 | 21.29 score on a scale | Standard Deviation 13.048 |
| Placebo | Alcohol Urge: Self-administration Block 2, Minute 30 | 23.29 score on a scale | Standard Deviation 12.079 |
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.
Time frame: 1 minute
Population: A total of 9 subjects were randomized and 7 completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitolisant | Alcohol Urge: Self-administration Block 2, Minute 60 | 22.00 score on a scale | Standard Deviation 12.055 |
| Placebo | Alcohol Urge: Self-administration Block 2, Minute 60 | 22.43 score on a scale | Standard Deviation 11.731 |