- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04596267
Pitolisant Effects on Alcohol Self-Administration in Heavy Drinkers
November 9, 2023 updated by: Boston Medical Center
The Effects of the Histamine-3 Receptor Inverse Agonist Pitolisant on Alcohol Self-Administration in Heavy Drinkers
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
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Eric Devine, PhD
- Phone Number: 617-414-1990
- Email: eric.devine@bmc.org
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02118
- Boston University Psychiatry Research Center, Clinical Studies Unit
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 21-55 years of age
- Able to verify age with a state or federal picture identification
- 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)
- Reports at least one episode of binge drinking (>3 drinks for women, >4 drinks for men) in the 28 days prior consent.
- Meets DSM-5 criteria for mild alcohol use disorder or greater severity.
- Has a smartphone to complete medication exposure period study assessments.
Exclusion Criteria:
- Seeking treatment for alcohol problems
- Clinical Institute Withdrawal Assessment at ≥10
- 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
- If female, pregnant, nursing, have plans to become pregnant
- If female, does not agree to use an accepted form of birth control
- Has a medical contraindication to the use of pitolisant
- Has medical or mental condition for which further alcohol exposure at the planned dose range would be contraindicated
- Current risk of suicidality (MINI suicidality score greater than 8 (low risk) or Yes to the ideation question #4 of the C-SSRS)
- BMI is greater than 40 or less than 18
- Impaired renal function (GFR <80 mL/min)
- Have a history of any clinically significant renal or hepatic disease
- 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]
- 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
- 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
- Has received alcohol counseling or other non-pharmacologic intervention to treat AUD in the past 90 days
- Has taken medications that are used to treat AUD in the past 90 days
- Has urine toxicology results positive for cocaine, opioids, amphetamines, buprenorphine, methadone, methamphetamines, oxycontin, barbiturates, or benzodiazepines.
- 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).
- Subject is known to be a poor CYP2D6 metabolizer.
- Subject is unable to comfortably abstain from nicotine for a period of 8 hours.
- 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.).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pitolisant
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.
|
8.9mg Pitolisant for 5 days
Other Names:
|
Placebo Comparator: Placebo
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.
|
Inert ingredients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alcohol Consumption in Alcohol Self-Administration Trials
Time Frame: 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.
|
2.6 hours
|
Alcohol Consumption (BAC): Observation Period, Minute 10
Time Frame: 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
|
1 minute
|
Alcohol Consumption (BAC): Observation Period, Minute 20
Time Frame: 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.
|
1 minute
|
Alcohol Consumption (BAC): Observation Period, Minute 30
Time Frame: 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.
|
1 minute
|
Alcohol Consumption (BAC): Observation Period, Minute 40
Time Frame: 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.
|
1 minute
|
Alcohol Consumption (BAC): Self-administration Block 1, Minute 30
Time Frame: 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.
|
1 minute
|
Alcohol Consumption (BAC): Self-administration Block 1, Minute 60
Time Frame: 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.
|
1 minute
|
Alcohol Consumption (BAC): Self-administration Block 2, Minute 30
Time Frame: 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.
|
1 minute
|
Alcohol Consumption (BAC): Self-administration Block 2, Minute 60
Time Frame: 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.
|
1 minute
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alcohol Craving During 12-day Drug Exposure
Time Frame: 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.
|
12 days
|
Alcohol Consumption During the 12-day Drug Exposure
Time Frame: 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.
|
12 days
|
Alcohol-induced Stimulation: Observation Period, Minute 10
Time Frame: 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.
|
1 minute
|
Alcohol-induced Stimulation: Observation Period, Minute 20
Time Frame: 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.
|
1 minute
|
Alcohol-induced Stimulation: Observation Period, Minute 30
Time Frame: 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.
|
1 minute
|
Alcohol-induced Stimulation: Observation Period, Minute 40
Time Frame: 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.
|
1 minute
|
Alcohol-induced Stimulation: Self-Administration Block 1, Minute 30
Time Frame: 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.
|
1 minute
|
Alcohol-induced Stimulation: Self-Administration Block 1, Minute 60
Time Frame: 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.
|
1 minute
|
Alcohol-induced Stimulation: Self-Administration Block 2, Minute 30
Time Frame: 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.
|
1 minute
|
Alcohol-induced Stimulation: Self-Administration Block 2, Minute 60
Time Frame: 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.
|
1 minute
|
Alcohol-induced Sedation: Observation Period, Minute 10
Time Frame: 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.
|
1 minute
|
Alcohol-induced Sedation: Observation Period, Minute 20
Time Frame: 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.
|
1 minute
|
Alcohol-induced Sedation: Observation Period, Minute 30
Time Frame: 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.
|
1 minute
|
Alcohol-induced Sedation: Observation Period, Minute 40
Time Frame: 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.
|
1 minute
|
Alcohol-induced Sedation: Self-Administration Block 1, Minute 30
Time Frame: 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.
|
1 minute
|
Alcohol-induced Sedation: Self-administration Block 1, Minute 60
Time Frame: 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.
|
1 minute
|
Alcohol-induced Sedation: Self-administration Block 2, Minute 30
Time Frame: 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.
|
1 minute
|
Alcohol-induced Sedation: Self-administration Block 2, Minute 60
Time Frame: 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.
|
1 minute
|
Alcohol Urge: Self-administration Block 1, Minute 30
Time Frame: 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.
|
1 minute
|
Alcohol Urge: Self-administration Block 1, Minute 60
Time Frame: 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.
|
1 minute
|
Alcohol Urge: Self-administration Block 2, Minute 30
Time Frame: 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.
|
1 minute
|
Alcohol Urge: Self-administration Block 2, Minute 60
Time Frame: 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.
|
1 minute
|
Alcohol Craving: Observation Period, Minute 10
Time Frame: 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.
|
1 minute
|
Alcohol Craving: Observation Period, Minute 20
Time Frame: 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.
|
1 minute
|
Alcohol Craving: Observation Period, Minute 30
Time Frame: 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.
|
1 minute
|
Alcohol Craving: Observation Period, Minute 40
Time Frame: 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.
|
1 minute
|
Alcohol Craving: Self-administration Block 1, Minute 30
Time Frame: 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.
|
1 minute
|
Alcohol Craving: Self-administration Block 1, Minute 60
Time Frame: 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.
|
1 minute
|
Alcohol Craving: Self-administration Block 2, Minute 30
Time Frame: 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.
|
1 minute
|
Alcohol Craving: Self-administration Block 2, Minute 60
Time Frame: 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.
|
1 minute
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Eric Devine, PhD, Boston Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 13, 2021
Primary Completion (Actual)
February 3, 2023
Study Completion (Actual)
February 3, 2023
Study Registration Dates
First Submitted
October 15, 2020
First Submitted That Met QC Criteria
October 15, 2020
First Posted (Actual)
October 22, 2020
Study Record Updates
Last Update Posted (Actual)
December 4, 2023
Last Update Submitted That Met QC Criteria
November 9, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-40959
- 1R21AA028864-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Deidentified data from this study will be submitted to the NIAAA Data archive (https://nda.nih.gov/).
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alcohol Drinking
-
University of North Carolina, Chapel HillNational Institute on Alcohol Abuse and Alcoholism (NIAAA)RecruitingDrinking Behavior | Adolescent Behavior | Drinking, Alcohol | Alcohol Drinking, AdolescentUnited States
-
Boston University Charles River CampusRecruiting
-
University of Auckland, New ZealandTe Hiringa Hauora/Health Promotion AgencyCompletedDrinking, Alcohol | Consumption, AlcoholNew Zealand
-
University of ArkansasRecruitingDrinking Behavior | Drinking Excessive | DrinkingUnited States
-
Butler HospitalNational Institute of General Medical Sciences (NIGMS)CompletedDrinking, AlcoholUnited States
-
Real Prevention, LLCCompletedUnderage Drinking | Alcohol Use, UnderageUnited States
-
University of FloridaNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Active, not recruiting
-
University of North Texas Health Science CenterNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Completed
-
Universidad de GranadaCompletedExercise | Drinking, AlcoholSpain
-
Lehigh UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA); Brown UniversityCompletedCollege DrinkingUnited States
Clinical Trials on Pitolisant
-
BioprojetCompleted
-
BioprojetCompletedEfficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's Disease (HARPS1)Parkinson's DiseaseFrance
-
BioprojetCompletedEfficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's Disease (HARPS2)Parkinson's DiseaseGermany
-
William Ondo, MDHarmony Biosciences, LLCRecruiting
-
BioprojetCompletedNarcolepsy | CataplexyFrance
-
BioprojetCompletedBF2.649 in Patients With OSA, Still Complaining of EDS and Refusing to be Treated by CPAP. (HAROSA2)Obstructive Sleep Apnea | Excessive Daytime SleepinessFrance
-
BioprojetCompletedExcessive Daytime Sleepiness | Obstructive Sleep ApnoeaFrance
-
BioprojetCompletedObstructive Sleep Apnea | Excessive Daytime SleepinessFrance
-
Harmony Biosciences, LLCActive, not recruitingIdiopathic Hypersomnia | Excessive Daytime SleepinessUnited States
-
Harmony Biosciences, LLCActive, not recruitingMyotonic Dystrophy 1 | Excessive Daytime SleepinessUnited States, Canada