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Role of BP1.3656 on Alcohol Responses
Phase 2
Waitlist Available
Research Sponsored by Centre for Addiction and Mental Health
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 measured during the 2nd week of the 14-day placebo phase
Summary
This trial is testing a new drug called BP1.3656 on people with Alcohol Use Disorder who are not currently seeking treatment. The drug helps break down certain chemicals and boosts brain chemicals that can affect mood and behavior, which might help reduce alcohol consumption.
Eligible Conditions
- Alcoholism
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured during the 2nd week of the 14-day placebo phase
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured during the 2nd week of the 14-day placebo phase
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Motivation for alcohol completed during a progressive ratio alcohol self-administration session while taking placebo.
Motivation for alcohol completed during a progressive ratio alcohol self-administration session while taking study medication (BP1.3656).
Peak breath alcohol concentration (mg%) during free-access alcohol self-administration while taking placebo.
+1 moreSecondary study objectives
Safety and tolerability of BP1.3656
Self-reported craving after a priming dose of alcohol during free-access and progressive ratio self-administration sessions while taking BP1.3656, as measured by the Alcohol Urge Questionnaire (1-7 scoring)
Self-reported craving after a priming dose of alcohol during free-access and progressive ratio self-administration sessions while taking placebo, as measured by the Alcohol Urge Questionnaire (1-7 scoring)
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Medication (BP1.3656)Experimental Treatment1 Intervention
Participants will receive BP1.3656 in tablet form once daily at a dose of 30 µg/day for the first 4 days, followed by 60 µg/day for the remaining 10 days. If the highest dose is not tolerated, it will be lowered to 30 µg.
Group II: Placebo pillsPlacebo Group1 Intervention
Participants will receive matching placebo pills for 14 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BP1.3656
2021
Completed Phase 2
~40
Find a Location
Who is running the clinical trial?
Centre for Addiction and Mental HealthLead Sponsor
372 Previous Clinical Trials
82,798 Total Patients Enrolled
20 Trials studying Alcoholism
3,716 Patients Enrolled for Alcoholism