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Histamine H3 Receptor Antagonist
Pitolisant Effects on Alcohol Self-Administration in Heavy Drinkers
Phase 1
Waitlist Available
Led By Eric Devine, PhD
Research Sponsored by Boston Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2.6 hours
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved
Summary
This trial tests whether Pitolisant, a narcolepsy medication, can reduce alcohol cravings and consumption in heavy drinkers who are not seeking treatment. It works by affecting brain receptors related to craving behaviors. The study aims to see if participants drink less alcohol when taking Pitolisant. Pitolisant is a medication primarily used to treat narcolepsy by reducing excessive daytime sleepiness and cataplexy.
Eligible Conditions
- Alcoholism
- Alcohol Consumption
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2.6 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2.6 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Alcohol Consumption (BAC): Observation Period, Minute 10
Alcohol Consumption (BAC): Observation Period, Minute 20
Alcohol Consumption (BAC): Observation Period, Minute 30
+6 moreSecondary study objectives
Alcohol Consumption During the 12-day Drug Exposure
Alcohol Craving During 12-day Drug Exposure
Alcohol Craving: Observation Period, Minute 10
+27 moreAwards & Highlights
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: PitolisantExperimental Treatment1 Intervention
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.
Group II: PlaceboPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pitolisant
FDA approved
Find a Location
Who is running the clinical trial?
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
837 Previous Clinical Trials
1,083,025 Total Patients Enrolled
458 Trials studying Alcoholism
824,041 Patients Enrolled for Alcoholism
Boston Medical CenterLead Sponsor
404 Previous Clinical Trials
884,896 Total Patients Enrolled
11 Trials studying Alcoholism
6,202 Patients Enrolled for Alcoholism
Eric Devine, PhDPrincipal InvestigatorBoston Medical Center
3 Previous Clinical Trials
83 Total Patients Enrolled
2 Trials studying Alcoholism
74 Patients Enrolled for Alcoholism