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Histamine H3 Receptor Antagonist

Pitolisant for Alcoholism

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2.6 hours for reporting.

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 more

Secondary study objectives

Alcohol Consumption During the 12-day Drug Exposure

Alcohol Craving During 12-day Drug Exposure

Alcohol Craving: Observation Period, Minute 10

+27 more

Awards & 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

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