Medication (BP1.3656) for Alcoholism

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured during the 2nd week of the 14-day placebo phase for reporting.

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 more

Secondary 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 more

Trial 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

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