Randomized Clinical Trial Evaluating BP1.3656 Versus Placebo For Alcohol Use Disorder Treatment

A Multisite Randomized Clinical Trial Evaluating BP1.3656 Vs Placebo For Alcohol Use Disorder Treatment

A Multisite Randomized Clinical Trial Evaluating BP1.3656 Vs Placebo For Alcohol Use Disorder Treatment.

Study Overview

• Status: Completed
• Conditions: Alcohol Use Disorder
• Intervention / Treatment: Drug: BP1.3656 low dose; Drug: BP1.3656 intermediate dose; Drug: Placebo; Drug: BP1.3656 high dose

Detailed Description

Proof of concept study evaluating in alcohol use disorder, the ability of psychosocial support in combination with BP1.3656 to reduce alcohol consumption. The study will be a multicenter, randomized, double-blind, placebo-controlled phase II trial with parallel groups to evaluate the effectiveness and the safety of BP1.3656.

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Phase 2

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria, 1303
    • State Psychiatric Hospital for Treatment of drug addiction and alcoholism
• France
  • Amiens, France, 80054
    • CHU Amiens Picardie
• Russian Federation
  • Leningrad, Russian Federation, 188661
    • Leningrad Regional Narcology Dispensary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female alcohol use disorder
• Ages 18-65
• Absent or minimal alcohol withdrawal symptoms assessed
• 18 kg/m2 ≤ BMI ≤ 35 kg/m2
• Excessive alcohol use during the 2 weeks between screening and baseline
• Voluntarily expressed willingness to participate in the study, understanding protocol procedures and having signed and dated an informed consent prior to the start of protocol required procedures while not intoxicated (BAC<0.05).

Exclusion Criteria:

• History of delirium tremens, epilepsy, or withdrawal seizures
• Clinical depression or suicidality: Beck Depression Inventory (BDI) ≥ 16 and suicidality (Item G ≠ 0)
• Recent illicit drug use, i.e. cannabis, cocaine, amphetamines or opioids
• Clinically significant cardiovascular, hematologic, severe hepatic impairment
• History of psychosis, or current severe psychiatric disorder, e.g. schizophrenia, bipolar disorder, severe depression or organic brain syndrome unrelated to alcohol abuse
• Physical dependence on sedatives or hypnotics that requires pharmacologically supported detox
• Receiving ongoing alcohol use disorder medication (e.g. Baclofen)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BP1.3656 low dose; administration of BP1.3656 at 30 µg	Drug: BP1.3656 low dose; Tablet, once daily oral administration at the low dose
Experimental: BP1.3656 intermediate dose; administration of BP1.3656 at 60 µg	Drug: BP1.3656 intermediate dose; Tablet, once daily oral administration at the intermediate dose
Placebo Comparator: Placebo; administration of placebo	Drug: Placebo; Tablet, once daily oral administration
Experimental: BP1.3656 high dose; administration of BP1.3656 at 90 µg	Drug: BP1.3656 high dose; Tablet, once daily oral administration at the high dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease in number of monthly Heavy Drinking Days (HDDs/month)	Decrease in number of monthly heavy drinking days (HDD/month) from baseline to the end of the double blind Randomized Treatment.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total daily alcohol consumption (TAC)	Total daily alcohol consumption (TAC) from baseline to the end of treatment	12 weeks
Percent of patients without Heavy Drinking Days (HDDs)	Percent of patients without HDDs during the 12-week medication phase	12 weeks

Collaborators and Investigators

• Sponsor: Bioprojet
• Investigators: Principal Investigator: Evgeny Krupitsky, Pr, Leningrad Regional Narcology Dispensary, Russia

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2018
• Primary Completion (Actual): November 24, 2021
• Study Completion (Actual): November 24, 2021

Study Registration Dates

• First Submitted: January 26, 2018
• First Submitted That Met QC Criteria: February 6, 2018
• First Posted (Actual): February 7, 2018

Study Record Updates

• Last Update Posted (Actual): January 21, 2022
• Last Update Submitted That Met QC Criteria: January 6, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Alcohol Drinking; Alcoholism
• Other Study ID Numbers: P15-01 / BP1.3656; 2017-000069-57 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No