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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
Awards & highlights

Study Summary

The current study will determine whether a novel pharmacotherapy, BP1. 3656, affects laboratory alcohol self-administration in participants with alcohol use disorder (AUD).

Eligible Conditions
  • Alcoholism

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

Find a Location

Who is running the clinical trial?

Centre for Addiction and Mental HealthLead Sponsor
354 Previous Clinical Trials
81,083 Total Patients Enrolled
16 Trials studying Alcoholism
3,468 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.
Recent research and studies
clinicaltrials.govStudy
Role of BP1.3656 on Alcohol Responses
2021. "Role of BP1.3656 on Alcohol Responses". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04727086.
~9 spots leftby Apr 2025
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