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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

Study Summary

This trial will test whether pitolisant can reduce alcohol consumption and craving.

Eligible Conditions
  • Alcoholism
  • Alcohol Consumption

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Alcohol Consumption (BAC): Observation Period, Minute 10
Alcohol Consumption (BAC): Observation Period, Minute 20
Alcohol Consumption (BAC): Observation Period, Minute 30
+6 more
Secondary outcome measures
Alcohol Consumption During the 12-day Drug Exposure
Alcohol Craving During 12-day Drug Exposure
Alcohol Craving: Observation Period, Minute 10
+27 more

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
800 Previous Clinical Trials
1,362,988 Total Patients Enrolled
423 Trials studying Alcoholism
985,699 Patients Enrolled for Alcoholism
Boston Medical CenterLead Sponsor
383 Previous Clinical Trials
871,140 Total Patients Enrolled
11 Trials studying Alcoholism
6,256 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Massachusetts
How old are they?
18 - 65
What site did they apply to?
Boston University Psychiatry Research Center, Clinical Studies Unit
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Pitolisant Effects on Alcohol Self-Administration in Heavy Drinkers
2021. "Pitolisant Effects on Alcohol Self-Administration in Heavy Drinkers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04596267.
~3 spots leftby Apr 2025
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