A Phase 1 interventional study of Pitolisant and Placebo in Alcohol Use Disorder and Alcohol Drinking, sponsored by Boston Medical Center. Terminated at 1 site in United States. Open to participants aged 21 Years to 55 Years. Per ClinicalTrials.gov, last updated 2023-12-04.
Sponsored by Boston Medical Center · Phase 1, Interventional, and Treatment
Among 11 studies in Alcoholism by Boston Medical Center — none open to participants now, none under way, none of them phase 3. Alcoholism · Boston Medical Center.
Among the 11 studies in Alcoholism by Boston Medical Center, this one is the 9th largest by enrollment of the 10 interventional ones, is the only one that started in 2021, is one of 3 in phase 1, and was the 10th registered.
1,674 studies on the registry are indexed under Alcoholism; 331 are open to participants now.
This study's enrollment of 9 is below the median of 88 across 1,428 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →None of the 11 studies in Alcoholism by Boston Medical Center is open now.
Of the 239 Alcoholism studies recruiting now, 84 (35%) set no upper age limit and 133 (56%) stop at 75 or younger; 11 take children under 18; 64 take healthy volunteers.
This study: 21 Years to 55 Years · all sexes · no healthy volunteers.
The full table on the hub →11 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 1 started in 2021.
Median enrollment 148 across the 10 interventional studies, 46 across the 1 observational. Of the 11 that completed or were terminated, 6 (55%) have results posted.
Boston Medical Center is the lead sponsor of 323 studies on the registry; 33 are open to participants now.
Of its 34 completed or terminated interventional studies of FDA-regulated products, 28 (82%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 11 studies in Alcoholism by Boston Medical Center, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Pitolisant
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.
Drug: Placebo
8.9mg Pitolisant for 5 days
Also known as: wakix
Inert ingredients
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
| Milestone | Pitolisant Then Placebo | Placebo Then Pitolisant |
|---|---|---|
| Started | 4 | 5 |
| Completed | 3 | 4 |
| Not completed | 1 | 1 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Physician decision | 0 | 1 |
| Milestone | Pitolisant Then Placebo | Placebo Then Pitolisant |
|---|---|---|
| Started | 3 | 4 |
| Completed | 3 | 4 |
| Not completed | 0 | 0 |
| Milestone | Pitolisant Then Placebo | Placebo Then Pitolisant |
|---|---|---|
| Started | 3 | 4 |
| Completed | 3 | 4 |
| Not completed | 0 | 0 |
| Milestone | Pitolisant Then Placebo | Placebo Then Pitolisant |
|---|---|---|
| Started | 3 | 4 |
| Completed | 3 | 4 |
| Not completed | 0 | 0 |
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.
| Total SDUs | Pitolisant | Placebo |
|---|---|---|
| Alcohol Consumption in Alcohol Self-Administration Trials | 67.214 ± 25.759 | 66.786 ± 15.369 |
Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable
| Grams of alcohol/210 Liters of breath | Pitolisant | Placebo |
|---|---|---|
| Alcohol Consumption (BAC): Observation Period, Minute 10 | 0.034 ± 0.005 | 0.033 ± 0.010 |
Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable.
| Grams of alcohol/210 Liters of breath | Pitolisant | Placebo |
|---|---|---|
| Alcohol Consumption (BAC): Observation Period, Minute 20 | 0.038 ± 0.009 | 0.0364 ± 0.011 |
Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable.
| Grams of alcohol/210 Liters of breath | Pitolisant | Placebo |
|---|---|---|
| Alcohol Consumption (BAC): Observation Period, Minute 30 | 0.037 ± 0.003 | 0.034 ± 0.009 |
Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable.
| Grams of alcohol/210 Liters of breath | Pitolisant | Placebo |
|---|---|---|
| Alcohol Consumption (BAC): Observation Period, Minute 40 | 0.033 ± 0.006 | 0.031 ± 0.006 |
Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable.
| Grams of alcohol/210 Liters of breath | Pitolisant | Placebo |
|---|---|---|
| Alcohol Consumption (BAC): Self-administration Block 1, Minute 30 | 0.069 ± 0.046 | 0.063 ± 0.033 |
Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable.
| Grams of alcohol/210 Liters of breath | Pitolisant | Placebo |
|---|---|---|
| Alcohol Consumption (BAC): Self-administration Block 1, Minute 60 | 0.072 ± 0.037 | 0.047 ± 0.021 |
Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable.
| Grams of alcohol/210 Liters of breath | Pitolisant | Placebo |
|---|---|---|
| Alcohol Consumption (BAC): Self-administration Block 2, Minute 30 | 0.086 ± 0.040 | 0.075 ± 0.046 |
Alcohol consumption will be measured throughout the study by their Blood Alcohol Content (BAC) measured by a breathalyzer test. Lower BACs are favorable.
| Grams of alcohol/210 Liters of breath | Pitolisant | Placebo |
|---|---|---|
| Alcohol Consumption (BAC): Self-administration Block 2, Minute 60 | 0.079 ± 0.047 | 0.082 ± 0.056 |
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.
| score on a scale | Pitolisant | Placebo |
|---|---|---|
| Alcohol Craving During 12-day Drug Exposure | 53.2 ± 30.1 | 47.2 ± 33.7 |
Alcohol consumption during the 12 days of drug exposure will be measured using the timeline followback method. Lower (Standard Drink Units) SDUs are favorable.
| SDUs | Pitolisant | Placebo |
|---|---|---|
| Alcohol Consumption During the 12-day Drug Exposure | 67.2 ± 25.8 | 66.8 ± 15.4 |
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.
| score on a scale | Pitolisant | Placebo |
|---|---|---|
| Alcohol-induced Stimulation: Observation Period, Minute 10 | 31.714 ± 20.878 | 30.714 ± 12.433 |
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.
| score on a scale | Pitolisant | Placebo |
|---|---|---|
| Alcohol-induced Stimulation: Observation Period, Minute 20 | 31.429 ± 19.957 | 30.714 ± 12.433 |
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.
| score on a scale | Pitolisant | Placebo |
|---|---|---|
| Alcohol-induced Stimulation: Observation Period, Minute 30 | 29.571 ± 18.183 | 31.857 ± 13.322 |
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.
| score on a scale | Pitolisant | Placebo |
|---|---|---|
| Alcohol-induced Stimulation: Observation Period, Minute 40 | 29.714 ± 17.557 | 31.000 ± 14.944 |
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.
| score on a scale | Pitolisant | Placebo |
|---|---|---|
| Alcohol-induced Stimulation: Self-Administration Block 1, Minute 30 | 32.143 ± 19.463 | 32.000 ± 11.719 |
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.
| score on a scale | Pitolisant | Placebo |
|---|---|---|
| Alcohol-induced Stimulation: Self-Administration Block 1, Minute 60 | 31.571 ± 18.831 | 34.429 ± 14.954 |
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.
| score on a scale | Pitolisant | Placebo |
|---|---|---|
| Alcohol-induced Stimulation: Self-Administration Block 2, Minute 30 | 31.286 ± 17.792 | 33.714 ± 15.348 |
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.
| score on a scale | Pitolisant | Placebo |
|---|---|---|
| Alcohol-induced Stimulation: Self-Administration Block 2, Minute 60 | 28.714 ± 16.680 | 32.714 ± 16.007 |
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.
| score on a scale | Pitolisant | Placebo |
|---|---|---|
| Alcohol-induced Sedation: Observation Period, Minute 10 | 12.714 ± 8.920 | 18.857 ± 15.742 |
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.
| score on a scale | Pitolisant | Placebo |
|---|---|---|
| Alcohol-induced Sedation: Observation Period, Minute 20 | 9.429 ± 5.827 | 18.286 ± 14.407 |
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.
| score on a scale | Pitolisant | Placebo |
|---|---|---|
| Alcohol-induced Sedation: Observation Period, Minute 30 | 7.286 ± 5.407 | 18.286 ± 17.114 |
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.
| score on a scale | Pitolisant | Placebo |
|---|---|---|
| Alcohol-induced Sedation: Observation Period, Minute 40 | 8.571 ± 7.300 | 18.286 ± 17.026 |
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.
| score on a scale | Pitolisant | Placebo |
|---|---|---|
| Alcohol-induced Sedation: Self-Administration Block 1, Minute 30 | 9.714 ± 7.041 | 20.714 ± 18.848 |
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.
| score on a scale | Pitolisant | Placebo |
|---|---|---|
| Alcohol-induced Sedation: Self-administration Block 1, Minute 60 | 10.286 ± 8.440 | 18.143 ± 18.614 |
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.
| score on a scale | Pitolisant | Placebo |
|---|---|---|
| Alcohol-induced Sedation: Self-administration Block 2, Minute 30 | 11.286 ± 10.323 | 17.571 ± 18.537 |
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.
| score on a scale | Pitolisant | Placebo |
|---|---|---|
| Alcohol-induced Sedation: Self-administration Block 2, Minute 60 | 9.571 ± 14.316 | 16.286 ± 19.914 |
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.
| score on a scale | Pitolisant | Placebo |
|---|---|---|
| Alcohol Urge: Self-administration Block 1, Minute 30 | 26.57 ± 10.937 | 24.00 ± 3.964 |
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.
| score on a scale | Pitolisant | Placebo |
|---|---|---|
| Alcohol Urge: Self-administration Block 1, Minute 60 | 23.43 ± 11.674 | 27.14 ± 11.466 |
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.
| score on a scale | Pitolisant | Placebo |
|---|---|---|
| Alcohol Urge: Self-administration Block 2, Minute 30 | 21.29 ± 13.048 | 23.29 ± 12.079 |
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.
| score on a scale | Pitolisant | Placebo |
|---|---|---|
| Alcohol Urge: Self-administration Block 2, Minute 60 | 22.00 ± 12.055 | 22.43 ± 11.731 |
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.
| score on a scale | Pitolisant | Placebo |
|---|---|---|
| Alcohol Craving: Observation Period, Minute 10 | 44.57 ± 22.970 | 34.71 ± 21.623 |
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.
| score on a scale | Pitolisant | Placebo |
|---|---|---|
| Alcohol Craving: Observation Period, Minute 20 | 44.43 ± 31.405 | 37.14 ± 23.398 |
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.
| score on a scale | Pitolisant | Placebo |
|---|---|---|
| Alcohol Craving: Observation Period, Minute 30 | 47.29 ± 26.266 | 39.57 ± 26.038 |
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.
| score on a scale | Pitolisant | Placebo |
|---|---|---|
| Alcohol Craving: Observation Period, Minute 40 | 50.57 ± 29.051 | 34.86 ± 25.016 |
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.
| score on a scale | Pitolisant | Placebo |
|---|---|---|
| Alcohol Craving: Self-administration Block 1, Minute 30 | 41.29 ± 24.965 | 39.86 ± 28.962 |
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.
| score on a scale | Pitolisant | Placebo |
|---|---|---|
| Alcohol Craving: Self-administration Block 1, Minute 60 | 42.14 ± 27.492 | 40.86 ± 31.519 |
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.
| score on a scale | Pitolisant | Placebo |
|---|---|---|
| Alcohol Craving: Self-administration Block 2, Minute 30 | 35.00 ± 33.650 | 45.57 ± 31.133 |
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.
| score on a scale | Pitolisant | Placebo |
|---|---|---|
| Alcohol Craving: Self-administration Block 2, Minute 60 | 41.14 ± 35.315 | 42.43 ± 29.860 |
Collected over Up to 48 Days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pitolisant | 0/7 (0%) | 0/7 (0%) | 2/7 (28.6%) |
| Placebo | 0/7 (0%) | 0/7 (0%) | 2/7 (28.6%) |
| Event | Pitolisant | Placebo |
|---|---|---|
| Bright yellow urineRenal and urinary disorders | 2/7 | 2/7 |
| NauseaGastrointestinal disorders | 1/7 | 0/7 |
| Increased ThirstGeneral disorders | 1/7 | 0/7 |
| Left Ankle PainGeneral disorders | 1/7 | 0/7 |
| Right knee contusion with abrasionGeneral disorders | 1/7 | 0/7 |
| Age, Categorical(Participants) | Pitolisant Then Placebo | Placebo Then Pitolisant | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 4 | 5 | 9 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Pitolisant Then Placebo | Placebo Then Pitolisant | Total |
|---|---|---|---|
| Mean | 28 ± 6 | 33 ± 7.9 | 30.9 ± 7.1 |
| Sex: Female, Male(Participants) | Pitolisant Then Placebo | Placebo Then Pitolisant | Total |
|---|---|---|---|
| Female | 1 | 2 | 3 |
| Male | 3 | 3 | 6 |
| Ethnicity (NIH/OMB)(Participants) | Pitolisant Then Placebo | Placebo Then Pitolisant | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 4 | 5 | 9 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Pitolisant Then Placebo | Placebo Then Pitolisant | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 4 | 4 | 8 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Pitolisant Then Placebo | Placebo Then Pitolisant | Total |
|---|---|---|---|
| United States | 4 | 5 | 9 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Deidentified data from this study will be submitted to the NIAAA Data archive (https://nda.nih.gov/).
This study is terminated, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pitolisant